Another product recall for Sun Pharma
- Sun Pharmaceutical Industries is recalling 41,127 bottles of venlafaxine.
- The recall is voluntary and was initiated in June by Sun Pharma’s unit Caraco Pharmaceutical Laboratories Ltd. The FDA announced the recall Friday on its website.
- This action is classified as a phase II recall, meaning that adverse events associated with consuming this drug would be either temporary or medically reversible.
On May 16, BioPharma Dive reported on a very similar recall -- though that action was significantly larger. According to the FDA website, “Stability results found the product did not meet the drug release dissolution specifications.”
Currently, there is increased vigilance and oversight of Indian pharmaceutical manufacturers in light of a recent visit by FDA Commissioner Margaret Hamburg, and increased FDA funding for inspections in India.