- Cipla recalls 5.8 lakh packets of drugs prescribed for gastric ulcer treatment.
- USFDA cites health hazards in the affected lot due to cross-contamination with other products
- The affected lot was manufactured at Maharashtra’s Kurkumbh facility.
THD NewsDesk, Maharashtra: On January 10, pharmaceutical giant Cipla is recalled more than 5.8 lakh packets of esomeprazole magnesium from the US market. The generic drug is considered effective for reducing gastric ulcers from the US market, as per a report by the US Food and Drug Administration. According to the latest Enforcement Report by USFDA, the drug major recalls esomeprazole magnesium in unit dose packets in the strengths of 10 mg, 20 mg, and 40 mg.
The recalled lot was manufactured at Cipla’s Kurkumbh facility in Maharashtra and then supplied to its New Jersey-based subsidiary.
The USFDA had to recall the drug as it found out there was “cross-contamination with other products.” “The excipient, Crospovidone, NF is contaminated with theophylline,” it stated. Moreover, the USFDA has initiated the recall under class II recall because of exposure of the drug to a violative product. Such exposure could have resulted in temporary or medically reversible adverse health consequences, putting the consumers at risk.
USFDA has informed that Cipla has ordered the recall of 2,84,610 packets of 10 mg strength, 2,89,350 packets of 20 mg strength, and 6,491 packets in 40 mg of strength medicine.
Source – ET HealthWorld