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Sun Pharma, Wockhardt initiate voluntary drug recall in US market

Sun Pharma, Wockhardt initiate voluntary drug recall in US market

Sun Pharma recalls Bupropion Hydrochloride Extended-release Tablets USP (SR) used as an anti-depressant

Sun Pharma has reportedly initiated  a voluntary recall of multiple lots of Bupropion Hydrochloride Extended-release Tablets USP (SR), 200 mg, 60-count bottle, an anti-depressant used to treat major depressive disorder from the US market. The reason for the voluntary action is for “failed dissolution specification”, while Wockhardt has started recalling its Lisinopril Tablets USP, 5 mg and 20 mg from the same market for “CGMP violations”.

As many as 35,235 bottles (60 count) of Bupropion Hydrochloride extended-release tablets distributed by Sun Pharmaceutical Industries have been recalled.

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.

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’, as reported by PTI.

In a separate notification, FDA said Wockhardt Limited 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 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 6 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.

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    Source: PTI

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