Product Recalls

Brief description of the problem (reason for recall)

Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily Intake (ADI) threshold of 733 ng/day calculated by Pfizer, based on ICH M7 guidance, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Champix, batch 18069 and notified SAHPRA Regulatory Compliance Units. Recall process: Recall letter distributed to all healthcare professionals via medpages.

Advise for health professionals and distributors:

The company requested the immediate return of all the affected batch of Champix to the supplying distributor for full credit without delay. As a precautionary measure, distribution remains on hold of all Distribution Points under Pfizer control

Brief description of the problem (reason for recall)

The products are being recalled due to quality defect: the presence of a mutagenic impurity above the threshold limit observed during analysis, as requested by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on new Azido impurities [the presence of Azido (5-AMBBT) mutagesic impurity beyond total threshold limit was observed during analysis].

Advise for health professionals and distributors: 

Stock is blocked for distribution and immediate quarantine of stock is initiated in Distribution and Wholesales. Quantity of stock affected to be confirmed. Return any of the above products to your United Pharmaceutical Distributor (UPD) wholesaler.

*CLONAM 0.5mg and CLONAM 2 mg are both on state tender, code: RT289-2019, tender numbers: 51401516-00002 & 51401516-00001.

Brief description of the problem (reason for recall)

The products are being recalled due to quality defect: the tablet description should be cross-scored, but instead the tablet has only a single score.

Advise for health professionals and distributors:

All remaining stock at distributor put in quarantine to avoid sale and to prevent further stock from being distributed. Customers/ health professionals were sent a recall letter and feedback was requested regarding quantity of stock on hand. Available stock at customers to be returned and placed in quarantine.

Brief description of the problem (reason for recall)

The product was being recalled due to quality defect: Discoloration of tablets found in the batch.

Advise for health professionals and distributors:

The identified batches blocked for sale at Adcock Distribution centers and Hold Notification letter for Adco-Napamol tablets 5000’s was circulated to the Distributors and Wholesalers who bought directly from Adcock DCs. All stock of this batch must be immediately returned to your supplying wholesaler or distributor for full credit.

Brief description of the problem (reason for recall)

The product was being recalled due to quality defect: Discoloration of tablets found in the batch.

Advise for health professionals and distributors: 

The identified batches blocked for sale at Adcock Distribution centers and Hold Notification letter for Adco-Napamol tablets 5000’s was circulated to the Distributors and Wholesalers who bought directly from Adcock DCs. All stock of this batch must be immediately returned to your supplying wholesaler or distributor for full credit.

Brief description of the problem (reason for recall)

Austell Pharmaceuticals took the decision to initiate a voluntary recall on Azithromycin 200 mg/5 ml Powder for suspension. The recall is to be instituted due to some of the containers having defective primary packaging resulting in the seal being discoloured, which is not in line with the product specifications.

Advise for health professionals and distributors: 

The company requested immediate return of all units on hand of the batches mentioned above to their supplying wholesaler or distributor for a full credit.

Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all distribution points, recall initiated.

Brief description of the problem (reason for recall)

The products are being recalled due to quality defect: Presence of mutagesic azide impurity: The impurity, also known as known as 4-chloro azido methyl tetrazole, was detected during routine assessment and is formed during the manufacture of the active ingredient (API). The confirmed presence of a potential new azide impurity via their manufacturer was communicated to the API supplier (Zheijang Tianyu Pharmaceutical company).

Advise for health professionals and distributors:

As a precautionary measure all batches have been blocked for sale and immediate quarantine of stock is initiated in Distribution and Wholesales. Healthcare professionals are urged to return all inventory of ZARTAN CO 50/12,5 and ZARTAN CO 100/25 to their relevant distributor and/or wholesaler as soon as possible for reimbursement. Please retain this letter in a prominent position for at least one month in case of stock in transit.

Brief description of the problem (reason for recall)

These products are being recalled due to quality defect: Presence of impurity, also known as GTI 2 (5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole – CAS 152708-24-2) is formed during the manufacture of the active ingredient.

Advise for health professionals and distributors:

 Stock is blocked for distribution and immediate quarantine of stock is initiated.

Brief description of the problem (reason for recall) 

The products are being recalled due to quality defect: The company initiated an immediate recall of the following batches of the products, as listed above, following the detection of an azido impurity in the losartan active ingredient. The impurity, also known as 4-chloro azido methyl tetrazole is formed during the manufacture of the active ingredient.

Advise for health professionals and distributors:

Healthcare professionals are urged to return all stock on hand of the above batches of LOSAAR PLUS 50/12,5 and LOSAAR PLUS 100/25 to their relevant distributor and/or wholesaler as soon as possible for reimbursement. Please retain this letter in a prominent position for at least one month in case of stock in transit.

Brief description of the problem (reason for recall)

The products are being recalled due to quality defect: The company initiates an immediate recall of the following batches of the products, as listed above, following detection during periodic re-qualification of VHP (Vaporized Hydrogen Peroxide) decontamination cycle executed at Dr. Reddy’s Formulation Unit-07, for the Filling Isolator Equipment PR-E235 & PR-E3 l 8 (Zone 1 + 3) in Line-1, Biological Indicator (BI) failure observed at locations pertaining to ISl0- Lyo loading & unloading area. Root Cause: From the investigation it was concluded that the failure of VHP requalification run was due to improper distribution of the vaporized hydrogen peroxide vapours inside the isolator. The probable reason for the failure was due to the presence of polybags in the VHP distribution lines of Isolator IS10.

Advise for health professionals and distributors: 

The action was initiated to halt and facilitate return of any potential product available at wholesale level. Distribution points will be requested to return the impacted product via their routine distribution channel to receive credit for the relevant quantities returned. All product impacted in South Africa was quarantined at the warehouse facility and reconciled against the quantity distributed.

Brief description of the problem (reason for recall)

This product is being recalled due to a complaint relating to quality defect: The impacted batch of Dermadine Oral antiseptic solution was deemed to be defective and did not comply with the requirements of Act 101 of 1965 in terms of the product specification, Solution is clear – no iodine colour, smell or taste, (lack of efficacy).

Advise for health professionals and distributors:

Please refrain from selling or dispensing this batch. Stock of the affected the batch is re-called from the wholesalers and direct retailers, including cross- border customers, utilising company representatives.

Brief description of the problem (reason for recall)

This product is being recalled due to a complaint relating to quality defect: Complaint on the final product packaging of Osvaren 435mg/ 235m g film- coated tablets (a secondary label with new expiry date affixed on top of the originally printed one).

Advise for health professionals and distributors:

Immediate batch tracing, quarantine of stock from all distributors & their clients, immediate notification to recall the batches sent to the regulatory authority.

Brief description of the problem (reason for recall)

This product is being recalled due to a complaint relating to quality defect: The assay of the active pharmaceutical ingredient, chlorhexidine gluconate, is below approved specification and the efficacy of this product cannot be guaranteed, (Assay limit of Chlorhexidine Gluconate ut of specification).

Advise for health professionals and distributors:

Immediate batch tracing, quarantine of stock from all distributors & their clients, immediate notification to recall the batches

Brief description of the problem (reason for recall)

This recall is initiated due to detection of non-conformances to the Medicines and Related Substances Act (Act 101 of 1965), in terms of the printed packaging material packaging material of LANCAP 15 mg (14 capsules):  The schedule as per the carton [S4] does not align to the consolidated schedules, in that a product containing 15 mg of Lansoprazole as a maximum daily dose and for a maximum treatment period of 14 days is indicated under S2. The indication per the carton (for the relief of heartburn and hyperacidity) is in line with S2 of the consolidated schedules, however this does not align with the S4 scheduling included on the carton.

Advise for health professionals and distributors:

The company requested their clients to quarantine, refrain from selling and to return all inventory of LANCAP 15 mg (14 capsules), [S4] medication to their relevant distributor and/or wholesaler with immediate effect for reimbursement.

 Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated.

Brief description of the problem (reason for recall)

The product was being recalled due to quality defect:The product was found to have microbial counts with yeast (Millerozyma farinose) and mould; the count was above specification. Out of Specification results were then reported by customer whilst using customer method (undiluted), which was confirmed by the manufacturer using customer method. The recall was requested based on the presence and count of the organism.

Recall process: Recall letters have been distributed to all Distributors.

Advise for health professionals and distributors:

The manufacturer requested for the immediate return of all the affected batches of Lactulose concentrate API to the supplying distributor without delay. As a precautionary measure, distribution remains on hold for all stock on site at the manufacturer and no manufacturing is taking place until corrective measures are confirmed.

Brief description of the problem (reason for recall)

The product was being recalled due to quality defect: Floaters that look like mould were found inside a few number of ampoules.

Advise for health professionals and distributors:

As a safety precautionary measure, due to affected units found, Equity Pharmaceuticals (Pty) Ltd recommends that healthcare providers should immediately discontinue the use of PROTA injection and to return all units of PROTA to Equity Pharmaceuticals (Pty) Ltd. and send an email to section21@equitypharma.co.za to arrange for upliftment and credit. They are also advised to retain the recall letter in a prominent position for one month.

Brief description of the problem (reason for recall)

This product is being recalled due to a quality defect: N-Nitroso-quinapril was detected in Accumax batches tested to be above the Acceptable Daily Intake. According to the Applicant, the nitrosamine (N-Nitroso-quinapril) detected in this product is a newly identified one.

The acceptable daily intake limit (AI) calculated should be 18 ng/day.

Advise for health professionals and distributors:

An Immediate batch tracing, quarantine of stock from all distributors & their clients was conducted.  Also, an immediate notification to recall the batches was sent to the regulatory Authority (SAHPRA). A recall letter was distributed to all healthcare professionals via medpages.

Customers were advised, in a form of a recall letter, to return the units of the batches listed in the table to their supplying distributor/wholesaler for full credit without delay.

For further product information or medical queries, please address this to: Pfizer’s Medical Information on 0860 734 937 (or email at Med.Info2@Pfizer.com ).

Brief description of the problem (reason for recall)

The recall is due to out of specification results for dissolution during stability studies, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Demetrin 10 mg, batch DT3236.

Advise for health professionals and distributors:

The company requested the return of all stock of the affected batch to the supplying distributor/wholesaler for full credit without delay.

Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall initiated.

Brief description of the problem (reason for recall)

Cipla Medpro (Pty) Ltd, in collaboration with SAHPRA, is recalling the above-mentioned batches of Coryx Throat Spray.

The reason for the Class I Type A product recall is the remote possibility that the spray nozzle may detach from the spray mechanism during use:

The company received two product complaints from two customers (1^st customer on 04.06.2021 & 2^nd customer on 06.12.2021) who purchased a bottle of Coryx Throat Spray.

Customer 1: The customer complained that the spray nozzle came off and was stuck in his throat, he was not able to remove it and the cap was swallowed. The customer further explained that his throat was damaged trying to remove the cap.

Customer 2: The customer complained that the spray nozzle of the bottle came off while he was using it and he involuntarily swallowed it.

Advise for health professionals and distributors:

All affected stock/ batches should be removed from the client’s inventory with immediate effect and returned via the normal distribution channel. The recall applies to all distribution points i.e. wholesalers throughout the country, hospital services (private as well as state hospitals), retail outlets, doctors, nurses, pharmacists, authorised prescribers and dispensers and individual customers or patients.

Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all the above-mentioned distribution points and an approved press statement released to public. Immediate recall has been initiated.

Media release Publication: eNCA Headline: Cipla recalls batches of Coryx throat spray

Link: https://www.enca.com/business/cipla-recalls-batches-coryx-throat-spray

Media Coverage confirmation: Coryx Throat recall

Brief description of the problem (reason for recall)

The products are being recalled due to quality defect: the company received customer complaints reporting discoloration of tablets and/or discoloured silica gel (complaints were either about discoloured silica gel sachets only or discoloured silica gel sachets and tablets with which the sachets had direct contact).

Advise for health professionals and distributors:

Affected stock has been blocked for distribution and the product placed on hold at Adcock Ingram distribution centers.

Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall Initiated.

Brief description of the problem (reason for recall)

The products are being recalled due to quality defect: Pinholes were found on the 10ml Water for Injection that is co-packaged with the Rocephin 1g Vial. These pinholes are melting defects located at the top of the ampoule head and surrounded by concavity.

Advise for health professionals and distributors:

Affected stock has been blocked for distribution and the applicant requested their clients for immediate return of the affected batch of Rocephin 1G Vial pack to the

supplying wholesaler or distributor for full credit.

Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, recall Initiated.

Brief description of the problem (reason for recall)

The products are being re-called due to quality defect; the company initiated a recall because the above batches are not in compliance with the registered requirements for the South African market, as follows:

1. The incorrect artwork for both the packaging insert and the unit carton. The languages are in English and Portuguese and should be in English and Afrikaans per the local market requirements.
2. The packs do not contain a Patient Information Leaflet.
3. The material for the primary packaging is not registered for the local market.
4. The sold packs do not have the SA registration on the artwork

Advise for health professionals and distributors:

The company has requested the customers to refrain from selling any of the affected batch(s) of the JANUMET 50/850 mg and 50/1000mg packs and return to them to their supplying warehouse / distributor with immediate effect.

Proposed action taken and its urgency: The recall has id initiated; a SAHPRA approved recall letter to be distributed to all distribution points

Brief description of the problem (reason for recall)

The products are being re-called due to quality defect: The company received a complaint from a customer who indicated that the product is foamy and smells fermented.

Advise for health professionals and distributors:

Affected stock has been blocked for distribution and the applicant requested their clients for immediate return of the affected batch.

Proposed action taken and its urgency: The recall is initiated; a SAHPRA approved recall letter to be distributed to all distribution points.

Brief description of the problem (reason for recall)

Austell Pharmaceuticals took the decision to initiate a voluntary recall on Azithromycin 200 mg/5 ml Powder for suspension. The recall is instituted due to some of the containers having defective primary packaging resulting in the seal being discoloured, which is not in line with the product specifications.

Advise for health professionals and distributors:

The company requested immediate return of all units on hand of the batches mentioned above to their supplying wholesaler or distributor for a full credit.

Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all distribution points, recall initiated.

Brief description of the problem (reason for recall)

iNova Pharmaceuticals took the decision to initiate a voluntary recall on Andolex-C Oral Gel. The recall is instituted due to Stability data assessed at 3 and 6 months which showed an out of specification result on microbiological growth on both batches and the assay value of Cetylpyridinium Chloride which tested below approved limits for batch 127226.

Advise for health professionals and distributors:

The company requested immediate blockage of stock on hand of the batches mentioned above, and for the distributors to be in contact with their customers who purchased the affected stock.

Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.

Brief description of the problem (reason for recall)

Viatris South Africa (Pty) Ltd took the decision to initiate a voluntary recall on Mizart 80 mg tablets. This recall is initiated in view of a complaint received, regarding comingling of tablets in a securi-tainer of Mizart 80 mg (30’s).

Advise for health professionals and distr

The company requested customers to refrain from selling Mizart 80mg tablets of the affected batch (batch nr. 8130141) and return it to their supplying warehouse or distributor with immediate effect. The applicant confirmed that they will ensure that the stock of batch 8130141 is replaced to their customers.

Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.

Brief description of the problem (reason for recall)

Sanofi Aventis South Africa (Pty) Ltd took the decision to initiate a voluntary recall on Lasix tablets 80 mg. The recall is instituted following the detection of a dissolution failure at the 6 months testing interval. The results for dissolution were below the required 80% after 60 minutes.

Advise for health professionals and distributors:

The company requests and urges their customers to return all stock on hand of Lasix 80mg tablets 30s, batch: CG022A to their relevant distributor and/or wholesaler as soon as possible for reimbursement.

Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.

Brief description of the problem (reason for recall)

Zydus Healthcare SA (Pty) Ltd took the decision to initiate a voluntary recall on Lumont 10 mg tablets. The recall is instituted due to out of specification results observed in dissolution test at 12 Month(s) time point interval in long term condition i.e., 30°C/75% RH.

Advise for health professionals and distributors:

The company requests all customers to refrain from selling or dispensing stock from the affected batch. Undistributed stock on hand placed on quarantine with immediate effect. All affected returned stock will be replaced free of charge.

Proposed action taken and its urgency: SAHPRA approved recall-letter distributed to all appropriate distribution points, recall initiated.

Brief description of the problem (reason for recall)

The recall is initiated because of the company’s use of a potentially corroded component in the manufacturing of the products at Heist. The use of the potentially corroded component creates the potential for stainless steel particulates in the formulations.

Advise for health professionals and distributors:

The company requested their clients to refrain from selling any of the affected batch(s) of CELESTONE SOLUSPAN Suspension for injection and to return them to their supplying warehouse or distributor with immediate effect. DSV Healthcare (Pty) Ltd will collect all their stock, which will be credited.

Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated

distributed to all distribution points and recall initiated.

Brief description of the problem (reason for recall)

The recall is due to an out of specification (OOS) result that was observed in Flomist nasal spray, batch no. IC20685. OOS result was observed in microbial enumeration test. The organism was identified as Burkholderia Cepacia

Cipla Medpro (Pty) Ltd, in South Africa took the decision to initiate a voluntary recall on batch IC20685.

Advise for health professionals and distributors:

The company requested their clients to refrain from selling or dispensing FLOMIST NASAL SPRAY, Batch No. IC20685 and to return all remaining stock to their supplying warehouse or distributor with immediate effect

Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated.

Brief description of the problem (reason for recall)

This recall is initiated due to an out of specification result for the assay test at 3 months testing interval at long term storage conditions i.e., 25°C/ 60%RH.

Advise for health professionals and distributors:

The company requested their clients to quarantine and refrain from selling any of the affected batch of Zodoray 0,25 µg capsules and return them to their supplying warehouse or distributor with immediate effect for reimbursement.

 Proposed action taken and its urgency: A SAHPRA approved recall letter distributed to all distribution points and recall initiated.

Other ingredients: [Thiamine: 260mg/50ml; Riboflavin: 2mg/50ml; Nicotinamide: 100mg/50ml; Pyridoxine: 5mg/50ml; D- Panthenonate: 5mg/50ml;

Magnesium: 1g/ 50ml and Methylcobalamin: 250ug/50ml]

Brief description of the problem (reason for recall)

The recall is due to reports of patients that have reacted to IV medicines, compounded by CPSA, and issued on prescription to medical practices. The medical practitioners of these patients communicated the information to the Compounding Pharmacy (the recall was initiated after the company (CPSA) was notified of patients being hospitalized). Details of complaints:                                                                                                                                   1 complaint: Nausea, vomiting, body aches, tachycardia, muscle weakness, headaches & shivers.
35 Complaints: Nausea, vomiting, body aches, tachycardia, muscle weakness, headaches & shivers.

Advise for health professionals and distributors:

The company requested their clients to refrain from dispensing the affected batches. An urgent notification (letter) was sent to all practices that received IVs containing the affected batches, as well as additional batches as a precautionary measure with immediate effect.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all clients and recall initiated.

distributed to all distribution points and recall initiated.

(Pholcodine 5 mg, Pholcodine 15 mg and Pholcodine 5 mg; Phenylephrine HCl 3.3 mg respectively)

Brief description of the problem (reason for recall)

iNova Pharmaceuticals (Pty) Ltd, in consultation with the SAHPRA has taken a decision to recall AND to withdraw all pholcodine containing medicines.

The decision to recall AND to withdraw is linked to a recently concluded French clinical study (the ALPHO Study) which reviewed a possible association between pholcodine and very rare but serious anaphylactic reactions to medicines called neuromuscular blocking agents (NMBAs) used in anaesthesia. iNova, based on SAHPRA’s recommendation has agreed to recall all stock in the market & withdraw the product completely from the market.

Data from the ALPHO study indicates that the use of pholcodine in the 12 months leading up to anaesthesia using NMBAs increases the risk of developing an anaphylactic reaction. The relationship between pholcodine and anaphylactic reactions to NMBAs has been hypothesised over the last decade, however, until the ALPHO study, no association had previously been established in any clinical study globally. It is further confirmed that there is still no evidence showing causal risk. However, based on the available data, there are currently no possible effective risk minimization measures which have been identified to mitigate against this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh the risks. Due to these considerations and the nature of the adverse reactions (including its unpredictability and clear timelines to onset), SAHPRA has recommended the withdrawal of all pholcodine-containing medicines from the South African market.

Advise for health professionals and distributors:

• Distribution and sale of the above-mentioned products should be ceased immediately.
• All batches of Pholtex Junior, Pholtex Forte and Pholtex Plus are to be returned to wholesaler/distributor.
• Customers are requested to retain the notification letter and place it in a prominent position for one month in case stock is in transit.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all clients, stock is blocked for sale by all distributors and recall initiated. This incident has been reported to other Reg Authorities, namely: NMRC, MCAZ, ZAMRA and BoMRA.

Description of the problem (reason for recall and for withdrawal from the market)

Dr Reddy’s Laboratories (Pty) Ltd, in consultation with the SAHPRA has taken a decision to recall Dopaquel 300mg film-coated tablets due to a complaint that was received in the above listed batch with a foreign plastic particle embedded in a broken tablet.

Advise for health professionals and distributors:

• Distribution and sale of the above-mentioned products should be ceased and immediate quarantine of any units of the above-mentioned batch that they have in their possession and must be returned via their normal distribution channel for full credit.
• Customers are requested to retain the notification letter and place it in a prominent position for one month.

Proposed action taken and its urgency: Any remaining stock is to be quarantined, stock is to be blocked for sale by all distributors. The SAHPRA approved recall letter is to be distributed to all clients and recall process initiated as per recall guideline. The affected batch was only distributed within South Africa.

Description of the problem (reason for recall and for withdrawal from the market)

B.Braun in consultation with the SAHPRA has taken a decision to recall their 0.9 % Sodium Chloride Infusion solution due to cross-contamination.  They have  been informed by their mother company in Germany regarding batches of solutions for infusion produced after Midazolam solution for infusion were detected to be cross-contaminated with traces of Midazolam above the PDE (Permitted Daily Exposure).

Advise for health professionals and distributors:

The company has requested the following from their customers:

• Do a visual check of the above-mentioned batches and separate
• Contact the customer you have supplied and arrange for return of the product to the hub if you are a wholesaler or distributor of the product. B.Braun will collect from your facility.
• Contact the B.Braun Customer Services Interaction Center for upliftment of the relevant

Proposed action taken and its urgency: Any remaining stock is to be quarantined, stock is to be blocked for sale by all distributors. The SAHPRA approved recall letter is to be distributed to all clients and recall process initiated as per recall guideline.