Cipla is recalling over 5.8 lakh packets of esomeprazole magnesium for delayed-release oral suspension in unit dose packets in strengths 10 mg, 20 mg and 40 mg in the US market, as per a report by the US Food and Drug Administration.
The drug is used for the reduction in the occurrence of gastric ulcers. Cipla has manufactured the affected lot at its Kurkumbh facility in Maharashtra and then supplied to its New Jersey-based subsidiary.
The USFDA cited “cross-contamination with other products” as the reason for the company recalling the product.
“The excipient, Crospovidone, NF is contaminated with theophylline,” it added.
As per the US regulator, the company is recalling 2,84,610 packets of 10 mg strength and 2,89,350 packets of 20 mg strength. Further, it is also recalling 6,491 packets of esomeprazole magnesium for delayed-release oral suspension in 40 mg strength.
The company has initiated the countrywide recall December 17, 2020, and the USFDA has classified it as a Class II recall.
In a separate statement, the USFDA said Strides Pharma, a subsidiary of Bengaluru-based Strides Pharma Science, is recalling 960 bottles of Tacrolimus capsules (100 mg) due to “failed moisture limits”.
The company has initiated the countrywide recall of the affected lot on December 22, 2020. The USFDA has classified it as a Class III recall, which is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.
(Edits by EP News Bureau)