The COMESA Competition Commission (“the Commission”) has become aware that on 5th October 2022, the World Health Organization (WHO) issued a Medical Product Alert, Ref: RPQ/REG/ISF/Alert N°6/2022, with regard to four substandard medicines manufactured by Maiden Pharmaceuticals Limited (Haryana, India), for failing to meet either their quality standards or specifications.
According to WHO, laboratory analysis on samples of the four products confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol, which are toxic to humans and can prove fatal when consumed. WHO further reported that toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death. The affected products have been identified in Gambia, but it is believed that they may be distributed to other countries or regions through informal markets.
The affected products are indicated below:
| Product Name | Manufacture and Expiry Dates | Lot number | Reported active ingredient | |
| 1. | Promethazine Oral Solution | Mfg: Dec-21
Exp: Nov -24 |
ML21-202 | Promethazine |
| 2. | Kofexmalin Baby Cough Syrup | Mfg: Dec-21
Exp: Nov -24 |
ML21-199 | Pheniramine Maleate, Ammonium Chloride, Menthol |
| 3. | Makoff Baby Cough Syrup | Mfg Dec-21
Exp: Nov -24 |
ML21-203 | Chlorphenamine Maleate, Phenylephrine HBR, Dextromethorphan syrup |
| 4. | Magrip N Cold Syrup | Mfg: Dec-21
Exp: Nov -24 |
ML21-198 | Paracetamol Phenylephrine HCL, Chlorphenamine Maleate |
In line with the WHO advise, the Commission wishes to appeal to the public not to use the above products, and in cases where the product has been consumed, and one has suffered from adverse reaction, they are advised to seek immediate medical advice from a qualified healthcare professional and the case be reported to the National Regulatory Authority or National Pharmacovigilance Centre, or reported to the WHO via rapidalert@who.int. Further details regarding the alert by WHO can be accessed through the following link: World Health Organization Medical Product Alert- Ref. RPQ/REG/ISF/Alert N°6/2022
The Commission pursuant to Article 30(1)(b) of the COMESA Competition Regulations (“the Regulations”), wishes to request any person who establishes that these products are being sold in the COMESA Region to report the matter to the Commission on +265 (0) 1 772466 or contact the undersigned on mdisasa@comesa.int; or Mr. Steven Kamukama, Manager Consumer Welfare and Advocacy Division on skamukama@comesa.int .
In addition, any person within the Common Market who purchased or is affected by the above medicines may also contact their national consumer institutions or any other body with the mandate on consumer protection in their countries.
Meti Demissie Disasa
Registrar
COMESA Competition Commission
5th Floor, Kang’ombe House
P.O. Box 30742, Lilongwe 3, Malawi
Office Phone: +265 (0) 1 772466
Email: compcom@comesa.int
CCC/DECISION/CP/1/2022
The Kenya Bureau of Standards (KEBS) has temporarily suspended several brands of edible oils and cooking fats by various oil refineries in Kenya, for failing to meet the requirements of the Standards Act, and the respective product standard KS EAS 769: KS 2019 Fortified Edible Oils & Fats – Specification. According to KEBS, the suspension aims to facilitate the protection of consumers from potentially unsafe products, and to allow the manufacturers of the non-compliant brands to initiate and put in place effective corrective action under KEBS supervision, before being allowed back into the market.
The COMESA Competition Commission (the “Commission”) hereby notifies the general public that Tiger Brands Limited, South Africa, (herein referred to as “Tiger Brands”), has recalled certain batches of its PURITY Essentials Baby Powder product. This follows a detection of trace levels of asbestos in test samples from a batch of pharmaceutical-grade talc powder used as raw material in the production of the finished powder products.
Various studies have established that talc powder contaminated with asbestos causes cancer, including the following:
Tiger Brands has indicated that the recall is precautionary as the raw material with the detected trace levels of asbestos did not meet the company’s quality and safety standards. However, the general public should be informed that the recall does not affect Purity Essentials Baby Cornstarch Powder or any other Baby Care products under the Purity brand.
The specific batches of the recalled baby powder are listed in the table below:
| Product Description | Weight | Barcode | |
| 1. | Purity Essentials Baby Powder/ Purity & Elizabeth Anne’s Essentials Baby Powder |
100g | 6009523601859 |
| 2. | Purity Essentials Baby Powder / Purity & Elizabeth Anne’s Essentials Baby Powder |
200g | 6009523601866 |
| 3. | Purity Essentials Baby Powder / Purity & Elizabeth Anne’s Essentials Baby Powder |
400g | 6009523601828 |
| 4. | Purity & Elizabeth Anne’s Fresh Baby Powder | 400g | 6009523604515 |
Further details regarding the product recall can be accessed through the following link:
Tiger Brands | Purity | Essentials Baby Powder
The Commission has established from Tiger Brands that the recalled products are sold within the Common Market, specifically in the Democratic Republic of Congo (DRC), Eswatini, Seychelles, Zambia, and Zimbabwe. Pursuant to Article 30(1)(b) of the COMESA Competition Regulations (“the Regulations”), the Commission therefore wishes to inform the general public to exercise caution and avoid the purchase or consumption of the above-recalled products, and return them to the point of purchase for a refund from Tiger Brands.
The Commission further wishes to advise any person who purchased and/ or consumed the product and is unable to secure a refund or compensation, or who establishes that the recalled product is being sold in other countries of the Common Market, to report the matter to the Commission on +265 (0) 1 772466 or contact the undersigned on mdisasa@comesa.int; or Mr. Steven Kamukama, Manager Consumer Welfare and Advocacy Division on skamukama@comesa.int. Affected persons may also contact their national consumer protection institutions or any other body with the mandate on consumer protection in their countries.
The Commission commends Tiger Brands for the proactive and cautious approach it has taken and wishes that other suppliers of consumer products act in a similar manner to ensure the health and safety of consumers is guaranteed.
Meti Demissie Disasa
Registrar
COMESA Competition Commission
5th Floor, Kang’ombe House
P.O. Box 30742, Lilongwe 3, Malawi
Office Phone: +265 (0) 1 772466
Email: compcom@comesa.int