Cipla the Drug company is recalling 7,228 bottles of Solifenacin Succinate tablets which is a medicine used to treat overactive bladder in the US market due to manufacturing issues.
According to the latest report of Enforcement issued by the US Food and Drug Administration (USFDA), the Mumbai-based company is recalling 10 mg, 30-count bottles in the US.
The company is recalling the 7,228 bottles due to “CGMP (current good manufacturing practices) deviations” stated the US health regulator. Cipla initiated the recall on June 10 this year and the USFDA has classified it as a Class II recall.
At the company’s Goa-based plant the recalled batches were produced and later it was shipped to its New Jersey-based arm Cipla USA Inc.
According to the USFDA report, 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.
Cipla is one of the largest generic drug makers with over 1,500 products in 65 therapeutic categories available in over 50 dosage forms
The USFDA cited “cross-contamination with other products” as the reason for the company recalling the product.
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.