)
Don't want to miss the best from Business Standard?
Sun Pharmaceutical and Wockhardt have separately initiated voluntary recall of a number of drugs from the US market due to different reasons.
Sun initiated voluntary recall of multiple lots of Bupropion Hydrochloride Extended-release Tablets USP (SR), 200 mg, 60-count bottle, 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 (USFDA), Sun's recall was initiated last month under a Class-III classification, '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 four-hour time point are not meeting specifications," the drug regulator said in its website.
As many as 35,235 bottles (60 count) of Bupropion Hydrochloride extended-release tablets distributed by Sun Pharmaceutical have been recalled. Comments from Sun officials on the recall were 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 USA market. The US regulator said the recall under a 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 USA 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.
TOTAL RECALL
- Sun started voluntary recall of multiple lots of Bupropion Hydrochloride Extended-release Tablets USP, 200 mg, 60-count bottle, from the US market
- Wockhardt initiated recalling its Lisinopril Tablets USP, 5 mg & 20 mg from the same market
