CONSUMER ALERT: RECALL OF OXYTOCIN INJECTION 10 IU/ML BATCH NO. 128109, MANUFACTURE DATE 02/2021 EXPIRY DATE 01/2023, MANUFACTURED BY GLAND PHARMACEUTICALS LTD, INDIA

Ref: CCC/CP/6/2022

17 November 2022

CONSUMER ALERT

RECALL OF OXYTOCIN INJECTION 10 IU/ML BATCH NO. 128109, MANUFACTURE DATE 02/2021 EXPIRY DATE 01/2023, MANUFACTURED BY GLAND PHARMACEUTICALS LTD, INDIA

The COMESA Competition Commission (“the Commission”) has become aware that on 12th October 2022, the National Medical Stores of Uganda issued a recall for the oxytocin injection 10 IU/ML batch no. 128109, Ref: NMS/ N° 22/6 manufactured on 02/2021 and expiring on 01/2023. The recalled drug is manufactured by Gland Pharmaceuticals Ltd, India and supplied by Gittoes Pharmaceuticals Ltd. The product batch was recalled as it failed the United States Pharmacopeia (USP) standard specifications for the visible particulate matter. The recall from the National Medical Stores of Uganda requested the general public to stop further use of the drug.

The Commission has established that recalled drug is supplied in the other Member States and therefore pursuant to Article 30(1)(b) of the COMESA Competition Regulations (the “Regulations”) wishes to alert the public and authorities in the Common Market on the possible risks of using the recalled batch of the above drug. Further, the Commission wishes to advise consumers who may have already used the recalled batch to seek medical advice from a qualified healthcare professional and report case to the National Drug Authority or any other relevant authorities.

The Commission wishes to request any person who establishes that the specific batch of the recall drug is 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 .

Affected persons 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

 

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