In the pharma industry context, product recalls are actions taken to address problems involving health products that are already in the market but have deficiencies related to safety, quality, efficacy, or presentation. 1
Recalls are a key weapon of vigilance that ensures medical products that are already in circulation, don’t cause undue harm to public health.
Marketing authorization holders may initiate recalls voluntarily or through a statutory recall from the national regulatory authority.
Regionally, African countries are making strides in ramping up their pharmacovigilance activities, and examples of these are seen through the proactive recalls that have already happened this year.
Let’s look at the top 10 recalls that have happened in the African market so far in 2024;
Novomix injection 30 Penfil, 3ml – South Africa
Authority: South African Health Products Regulatory Authority
Active Pharmaceutical Ingredient: Insulin Aspart
Indication: Rapid acting human insulin analog indicated for management of type-1 and type-2 diabetes mellitus to improve glycemic control in adults and children.
Manufacturer: Novo Nordisk
Batch number: NR7SE13
Reason for recall: Incidents of cracked cartridges found in cartridge batches from the cartridge supplier and used for filling of the insulin product.2
Amitrip Tablets – Kenya
National Regulatory Authority: Pharmacy and Poisons Board
Active Pharmaceutical Ingredient: Amitriptylline 25mg
Indication: Management of depression
Manufacturer: Laboratory & Allied Ltd
Batch number: 81647
Reason for recall: Quality issues of the drug presented as capping of the tablets.3
Xsone N eye/ear drops – Tanzania
National Regulatory Authority: Tanzania Medicines and Medical Devices Authority (TMDA)
Active Pharmaceutical Ingredient: Sodium Phosphate 0.1% w/v and Neomycin Sulphate 0.35% w/v
Indication: Management of swelling, redness, itching and allergice reactions that could be caused by infections in the eye.
Manufacturer: Abacus Parenteral Drugs Limited of Kampala, Uganda.
Batch number: 69E00123, 69D02323
Reason for recall: Instead of the approved clear and sterile aqueous solution the batches contained a brownish spot at the bottom of the vials was presented.4
Stopalgic Infusion – Tunisia
National Regulatory Authority: Direction De la Pharmacie et Du Medicament (Tunisia)
Active Pharmaceutical Ingredient: Paracetamol injection
Indication: Short-term treatment of moderate pain, particularly in the postoperative period, and short-term treatment of fever when the intravenous route is clinically justified by the urgency of treating pain or hyperthermia and/or when other routes of administration are not possible.
Manufacturer: Medis laboratories (Tunisia)
Batch number: 22P0065-1, 22P0065-3, 22P0065-4
Reason for recall: a non-conformity of organoleptic characteristics presented as a brown coloring of the solution.5
Arthrexin 25mg Capsules – South Africa
Authority: South African Health Products Regulatory Authority
Active Pharmaceutical Ingredient: Indomethacin 25mg
Indication: used to relieve pain and reduce inflammation (swelling, redness and soreness) caused by arthritis, gout, menstrual cramps and much more.
Market authorization holder: Aspen Pharmacare
Batch number: P0003739
Reason for recall: Some containers had erroneous labeling, which led to the start of the recall. In a bottle marked “Arthrexin 50 mg capsules,” a pharmacy discovered Arthrexin 25 mg capsules.2
Brexafemme 150mg tablets – Nigeria
Authority: National Agency For Food and Drug Administration and Control (NAFDAC)
Active Pharmaceutical Ingredient: Ibrexafungerp citrate
Manufacturer: Scynexis, Inc
Batch number: LF21000008, LF22000051
Reason for recall: potential cross contamination with a non- antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME tablets. Creating a risk of potentially fatal hyper-sensitivity reactions.3
Other comments: Not legally registered in the market.
Fluconazole 200mg Tablets – Rwanda
National Regulatory Authority: Rwanda Food and Drugs Authority
Active Pharmaceutical Ingredient: Fluconazole 200mg tablets
Indication: treatment of serious fungal or yeast infections, including vaginal candidiasis, oropharyngeal candidiasis, esophageal candidiasis, fungal (cryptococcal) meningitis and other infections.
Manufacturer: Universal Corporation Ltd (Kenya)
Batch numbers: 5810315, 5810316, 5811390, 5810022
Reason for recall: Quality issues of discoloration from the original pink color to white.3
Blink Injection – Kenya
National Regulatory Authority: Pharmacy and Poisons Board (Kenya)
Active Pharmaceutical Ingredient: Paracetamol 1% w/v
Indication: Management of pain and fever
Manufacturer: Shijiazhuang No.4 Pharmaceutical Co., Ltd
Batch number: 2211011
Reason for recall: Quality issue of the product presented as color change from a clear, colorless solution to a yellow solution.3
Phytomenadione injection – Rwanda
National Regulatory Authority: Rwanda Food and Drugs Authority
Active Pharmaceutical Ingredient: Phytomenadione 10mg – 1ml injection
Indication: management of bleeding or blood clotting problems occasioned by vitamin K deficiency, medical conditions and certain medicines
Manufacturer: Merit Organics Ltd (India)
Batch number: 113612
Reason for recall: Quality issues of variation of PH
Chlorpromazine 100mg Tablets – Kenya
National Regulatory Authority: Pharmacy and Poisons Board (Kenya)
Active Pharmaceutical Ingredient: Chlorpromazine 100mg
Indication: 82172, 82173,82174,79887
Manufacturer: Laboratory & Allied Ltd (Kenya)
Batch numbers: 82172, 82173,82174,79887
Reason for recall: Quality issues of the drug manifested as Capping/Lamination of the tablets.3
Conclusion
A lot still needs to be done to ensure that only good-quality, safe, and effective health products are circulating in the African market.
But it’s clear that national regulatory authorities are positioning themselves, through post-market surveillance, at the forefront of safeguarding public health.
The activities that they engage in ensure that lives are not unnecessarily lost during pharmacological therapies.
It needs concerted efforts from all stakeholders, including the market authorization holders who bring in the product, the healthcare worker who manages and provides the product, and the patient who puts these products in their bodies.
References
1. Product Recalls. SAHPRA. Accessed March 12, 2024. https://www.sahpra.org.za/product-recalls/
2. Public Alert No. 04/2024 –Alert on recall of Brexafemme® tablets 150 mg due to risk of cross-contamination – NAFDAC. Accessed March 12, 2024. https://www.nafdac.gov.ng/public-alert-no-04-2024-alert-on-recall-of-brexafemme-tablets-150-mg-due-to-risk-of-cross-contamination/
3. Rapid Alert 2024 – Pharmacy and Poisons Board. Published February 15, 2024. Accessed March 12, 2024. https://web.pharmacyboardkenya.org/rapid-alert-2024/
4. TMDA | Latest News. Accessed March 12, 2024. https://www.tmda.go.tz/announcements/recall-of-substandard-batches-of-xsone-n-eye-ear-d
5. dpm. Accessed March 12, 2024. http://www.dpm.tn/index.php?option=com_content&view=article&id=5
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About the author
Bevin Likuyani is a Pharmacist with a MPharm (Pharmacoepidemiology & Pharmacovigilance) and MBA (Strategic Management) from School of Business, University of Nairobi). He is a Certified Supply Chain Pharmacist. (American Association of Supply Chain Management) and content writer on pharmaceutical related topics. Email: bevin@africanpharmaceuticalreview.com LinkedIn