HYDERABAD:Sun Pharma and Wockhardt Ltd have separately initiated voluntary recall of several drugs from the US market citing various reasons.
While Sun recalled multiple lots of Bupropion Hydrochloride Extended-¬release Tablets USP (SR), 200 mg, 60-count bottle, for failed dissolution specification, Wockhardt recalled its Lisinopril Tablets USP, 5 mg and 20 mg for CGMP violations.
According to US FDA, Sun Pharma’s recall was initiated last month under Class-III classification, which was as ‘a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.’ Similarly, Wockhardt’s recall was also under class-II classification initiated last month.
Bupropion is an antidepressant used to treat major depressive disorder and seasonal affective disorder. “Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications,” the drug regulator said in its website on the reasons for recall.
As many as of Bupropion Hydrochloride extended-release tablets distributed by Sun Pharmaceutical Industries have been recalled.
Wockhardt’s Lisinopril tablets USP are indicated for the treatment of hypertension in adults and paediatric patients 6 years of age and older to lower blood pressure.