Sun Pharma’s recall was initiated last month under Class-III classification while Wockhardt’s recall was under class-II classification
Sun Pharma and Wockhardt have separately initiated voluntary recall of a number of drugs from the US market due to different reasons, as reported in PTI.
Sun Pharma initiated voluntary recall of multiple lots of Bupropion Hydrochloride Extended-release tablets USP (SR), 200 mg, 60-count bottle, from the US market for ‘failed dissolution specification,’ while Wockhardt started recalling its Lisinopril tablets USP, 5 mg and 20 mg from the same market for ‘CGMP violations.’
According to a notification issued by the US Food and Drug Administration, 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’
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 35,235 bottles (60 count) of Bupropion Hydrochloride extended-release tablets distributed by Sun Pharmaceutical Industries have been recalled.
Comments from Sun Pharma on the recall was, however, not available.
In a separate notification, FDA said Wockhardt also initiated voluntary recall of 1,704 and 3,378 bottles of its Lisinopril tablets USP, 5 mg and 20 mg respectively (both 1000-count ) bottles from the US market.
The US drug regulator said the recall under class-II classification was initiated last month and the drugs were manufactured in India.
“CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints,” the FDA said on the reason for recalling.
Lisinopril tablets USP are indicated for the treatment of hypertension in adult patients and paediatric patients six years of age and older to lower blood pressure.
According to the US health regulator, Class II recall is 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.