Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg.
Drug major Cipla is recalling over 5.8 lakh packets of a drug for the reduction in the occurrence of gastric ulcers from the US market, as per a report by the US Food and Drug Administration. The drug 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 latest Enforcement Report by the USFDA said. The drug firm 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.