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Caraco Pharmaceutical Laboratories, a unit of Sun Pharma, has initiated the recall of multiple lots of Cephalexin capsules from the US market.
According to a USFDA notification, the recall of 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles was voluntarily initiated by the company through a letter to the regulator in June under ‘Class-II’ classification.
Cephalexin is an antibiotic that belongs to the family of medications known as cephalosporins. It is used to treat certain types of bacterial infections.
“CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices,” USFDA’s website said citing the reason for the recall.
When contacted, a Sun Pharma spokesperson did not offer any comments.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories Ltd in the US while they were manufactured in India by Sun Pharmaceutical Industries Ltd.
According to the American health regulator USFDA, a 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.
Recently Caraco Pharmaceutical said it had initiated the recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market for not meeting the drug release dissolution specifications under ‘Class-II’ classification.
Meanwhile, in another notification, FDA said Wockhardt USA has initiated the recall of 840 bottles of Bupropion hydrochloride extended-release tablets USP (SR), 100 mg, (500-count bottle) from the US market. The reason for recall: “Out-of-specification levels of the impurity m-chlorobenzoic acid were observed”. Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorders.
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