Sun Pharmaceutical’s Caraco Pharmaceuticals Issues Voluntary Recall of Cephalexin

Caraco Pharmaceutical Laboratories, Ltd., a subsidiary of Sun Pharma USA, the US arm of the Mumbai-based Sun Pharmaceutical Industries. Ltd., has initiated a voluntary Class II recall of cephalexin capsules, USP, 250 mg, packaged in 100-count bottles (NDC 62756-293-88) and 500-count bottles (NDC 62756-293-13) because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured according to good manufacturing practice. 

Caraco initiated the voluntary recall on June 26, 2014; it was reported in the US Food and Drug Administration’s (FDA) weekly Enforcement Report of August 13, 2014. Cephalexin is an cephalosporin antibiotic.

The Class II recall applies to 70,152 bottles of the 100-count bottles and 43,525 bottles of the 500-count bottles for product distributed in the United States, including Puerto Rico.  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.

Earlier this year, Sun Pharmaceutical Industries Ltd announced that, as a part of its manufacturing consolidation in the US, it will cease manufacturing operations and close the Detroit facility of Caraco Pharmaceutical Laboratories. Also, earlier this year, Caraco issued a voluntary recall of select bottles of metformin.

In 2009, US marshals, at the request of  the FDA, seized drug products and ingredients manufactured by Caraco at the Detroit facilities as well as two other facilities in Michigan at Farmington Hills and Wixom. The action followed Caraco's failure to meet current good manufacturing practice requirements and the issuance of several voluntary recalls. Caraco corrected the violations and resumed operations in 2012 at the Detroit facility.

Source: FDA


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