Sun Pharma unit recalls cephalexin capsules from US: PTI

Caraco Pharmaceutical Laboratories, the US-based unit of Sun Pharmaceuticals, has initiated a recall of multiple lots of cephalexin capsules from the US market, according to a PTI report. Citing a notification by the USFDA, the report says that the recall of the 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles is voluntarily initiated by the company through a letter to the regulator in June under 'Class-II' classification.
 
Cephalexin, an antibiotic that belongs to the family of medications known as cephalosporins, 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 (GMP),” USFDA's website said citing the reason for recall.
 
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories in the US while manufactured by Sun Pharmaceutical Industries in India. According to American health regulator USFDA, 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 had said that it initiated a 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.
 
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