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New Delhi, Jan 10 (PTI) Drug major Cipla is recalling more than 5.8 lakh packets of a drug for the reduction in the occurrence of gastric ulcers from the US market, as per a report from the US Food and Drug Administration. The medication major is recalling esomeprazole magnesium for delayed-release oral suspension in unit dose packets in strengths 10 mg, 20 mg and 40 mg in the US market, the most recent Enforcement Report from the USFDA said.
The drug firm has manufactured the affected lot at its Kurkumbh centre in Maharashtra and then provided to its New Jersey-based subsidiary.
The USFDA cited”cross-contamination with other products” as the reason behind the company recalling the product.
“The excipient, Crospovidone, NF is infected with theophylline,” it added.
In accordance with 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’s also recalling 6,491 packets of esomeprazole magnesium for delayed-release oral suspension in 40 mg strength.
The business has initiated the countrywide recall December 17, 2020, along with the USFDA has classified it as a Class II recall.
In a separate statement, the USFDA said Strides Pharma Inc, a subsidiary of Bengaluru-based Strides Pharma Science, is recalling 960 bottles of Tacrolimus capsules (100mg) because of”failed moisture limits”.
The business has initiated the countrywide recall of the affected lot on December 22, 2020. The USFDA has classified it as a Class III recall, which can be initiated at a”situation in which use of, or exposure to, a violative product is unlikely to cause adverse health effects”. PTI MSS BAL
