Dr. Reddy’s Laboratories has issued a voluntary Class III recall for select lots and bottles of a combination of amlodipine besylate and atorvastatin calcium tablets due to possible subpotent atorvastatin. 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. The recall was initiated August 13, 2015 and issued nationwide in the US, according to the US Food and Drug Administration’s (FDA) Weekly Enforcement Report of September 2, 2015. The drugs were manufactured by Dr. Reddy’s Laboratories Limited in Bachupally, India.

The recall applies to the following: 1,056 bottles of amlodipine besylate and atorvastatin calcium tablets, 2.5 mg/10 mg, 30 count bottles; 576 bottles of amlodipine besylate and atorvastatin calcium tablets, 2.5 mg/20 mg, 30 count bottles; 984 bottles of amlodipine besylate and atorvastatin calcium tablets,2.5 mg/40 mg, 30 count bottles; 16,080 bottles and 480 bottles, respectively, of amlodipine besylate and atorvastatin calcium tablets, 10 mg/20 mg, packaged in 30 count bottles and 90 count bottles; 14,640 bottles and 624 bottles of amlodipine besylate and atorvastatin calcium tablets, 5 mg/20 mg, packaged respectively in 30 count bottles and 90 count bottles; 16,848 bottles and 216 bottles of amlodipine besylate and atorvastatin calcium tablets,10 mg/40 mg, packaged in 30-count bottles and 90-count bottles; 3,840 bottles of amlodipine besylate and atorvastatin calcium tablets, 10 mg/80 mg in 30 count bottles,

Source: FDA