‘Human anti-D immunoglobulin’ injection in market: DRAP issues immediate recall alerts

ISLAMABAD: Following the identification of falsified Rhophylac 300mcg PFS, human Anti-D immunoglobulin injection in market, the Drug Regulatory Authority of Pakistan (DRAP) has issued an immediate recall alert while directing the field force to increase the surveillance activities in market to confiscate the products.

The Anti-D immunoglobulin is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Falsified injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products

The DRAP in an advisory issued here on Friday directed to the National Regulatory Field Force, distribution, pharmacies, medical stores, healthcare professionals, physician, pharmacist, nurses, maternal and child health centres to not procure/supply unregistered drugs.

The regulator said that M/s HakimsonsImpex (Private) Ltd, Karachi, has notified DRAP regarding the presence of falsified Rhophylac 300mcg PFS in the market across Pakistan and also referred to letter No 438/PDI-ZR/PWR, received from provincial inspector, Peshawar for verification of the sample. The packaging of the product shows two different batch numbers while barcode scan displays another batch number.

The Anti-D immunoglobulin is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen).

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