Cipla recalls Solifenacin Succinate tablets in US over manufacturing issues
New Delhi: Drug major Cipla is recalling 7,228 bottles of Solifenacin Succinate tablets, a medicine used to treat overactive bladder, in the US market due to manufacturing issues.
As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), the Mumbai-based company is recalling 10 mg, 30-count bottles in the US.
The recalled batches were produced at the company''s Goa-based plant and later shipped to its New Jersey-based arm Cipla USA Inc.
The US health regulator noted that the company is recalling the 7,228 bottles due to "CGMP (current good manufacturing practices) deviations".
Cipla initiated the recall on June 10 this year and the USFDA has classified it as a Class II recall.
As per the USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
In January this year, the Mumbai-based drug firm had recalled over 5.8 lakh packets of a drug for the reduction in the occurrence of gastric ulcers from the US market.
The drug firm manufactured the affected lot at its Kurkumbh facility in Maharashtra and then supplied it to its New Jersey-based subsidiary.
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The USFDA cited "cross-contamination with other products" as the reason for the company recalling the product.
Cipla is one of the largest generic drug makers with over 1,500 products in 65 therapeutic categories available in over 50 dosage forms.
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