Morocco: medicines agency recalls batch of Pfizer’s Nivestim cancer drug

The Moroccan Agency for Medicines and Health Products has ordered the precautionary withdrawal of a single batch of Nivestim, a drug given to cancer patients, from the national market. A technical fault was detected in the temperature-recording system of the cold room where the batch was stored.

According to an official notice from the agency, the recall concerns only batch NG0631 of “NIVESTIM 30 MU/0,5 ml”, sold in boxes of five prefilled syringes for subcutaneous injection or intravenous injection and infusion. The measure was taken by the pharmaceutical manufacturer Pfizer in agreement with the competent health authorities.

The product contains the active substance filgrastim, which stimulates the production of white blood cells, particularly neutrophils, in patients undergoing chemotherapy. It is used to shorten the period during which these immune cells are depleted and to limit the risk of infection and fever linked to weakened immunity.

Hospital and community pharmacists, wholesale distributors, and public and private health facilities have been asked to stop distributing, dispensing and using the batch immediately. Existing stock is to be isolated and placed in precautionary quarantine before being returned in full in coordination with Pfizer.

The notice ties the recall to the failure of the temperature log. It does not state that the medicine was exposed to non-compliant temperatures or that any defect in its composition was found, nor does it report complications or health harm from using the batch.

No other batches are covered, and the decision does not amount to a withdrawal of the drug as a whole or a suspension of its sale in Morocco. Patients holding packs are advised to check the batch number and consult their treating doctor or pharmacist, and not to stop or change their treatment without specialist advice.