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;

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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

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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

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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

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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

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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.

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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

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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

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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

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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

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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.