Dr. Reddy’s Laboratories has issued a voluntary recall of select lots of divalproex sodium extended-release tablets due to failed dissolution specifications and select lots of amlodipine besylate and atorvastatin calcium tablets due to subpotency. The voluntary recalls were initiated in May 2015 and reported in the June 24, 2015 US Food and Drug Administration Weekly Enforcement Report.

The company issued a voluntary Class II recall of 7,479 bottles (100 count) and 2, 544 bottles (500 count) of divalproex sodium extended-release tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, prescription only, manufactured by Dr. Reddy’s Laboratories Limited, Bachupally India. The recall was due to failed dissolution specifications, specifically exceeding specification at the 9-hour time point. The voluntary recall was initiated on May 22, 2015 nationwide in the US. It applies to one lot of 100-count product and two lots of the 500-count product. The company also issued an additional voluntary call, also initiated on May 22, 2015, for an additional lot of divalproex sodium extended-release tablets, USP, 500 mg, 100 count bottles, also due to failed dissolution specifications, specifically exceeding specification at the 9-hour time point.

A Class II recall: 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.

The company also issued a voluntary Class III recall for six lots of amlodipine besylate and atorvastatin calcium tablets prescription only, manufactured by Dr. Reddy’s Laboratories Limited Bachupally, India. The recall was initiated nationwide in the US on May 5, 2015 due to subpotency. The affected lots include: 5 mg/10 mg packaged in 30-count bottles and 90-count bottles;10 mg/10 mg, packaged in 30-count bottles and 90-count bottles; 5 mg/40 mg packaged in 30-count bottles and 90-count bottles, and 10 mg/40 mg,packaged in 30-count bottles and 90-count bottles,

A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Source: FDA (divalproex), FDA (divalproex), FDA (amlodipine and atorvastatin), FDA (amlodipine and atorvastatin), FDA (amlodipine and atorvastatin), and FDA (amlodipine and atorvastatin),