Over 200,000 Statin Bottles Recalled

Dr. Reddy's Laboratories Inc. is recalling more than 200,000 bottles of atorvastatin calcium tablets, according to the June 27, 2018, US Food and Drug Administration (FDA) Enforcement Report. The drug is a prescription statin used to treat high cholesterol.

On May 30, 2018, the firm voluntarily recalled 6397 bottles of atorvastatin calcium tablets, 80 mg, 90-count (NDC 55111-124-90), from lot T800064 (Exp. 12/19), after a customer reported a foreign object embedded in a tablet. Bottles from the lot were distributed across the country. On June 18, 2018, the FDA designated the recall Class II, signaling use of the tablets could cause temporary or medically reversable harm, and a remote probability of serious adverse health consequences with use.

On June 12, 2018, Dr. Reddy's Laboratories voluntarily recalled several additional lots of atorvastatin calcium tablets distributed throughout the United States and Puerto Rico because they failed to meet impurities/degradation specifications. The recall, designated Class III by the FDA on June 21, 2018, included:

• 10-mg tablets packaged in 90-count bottles (NDC 55111-121-90) from lots T600327 (Exp. 7/18), and T700213 and T700215 (Exp. 4/19);
• 20-mg tablets packaged in 90-count bottles (NDC 55111-122-90) from lot T600328 (Exp. 7/18), and T700214 and T700216 (Exp. 4/19);
• 40-mg tablets packaged in 90-count bottles (NDC 55111-123-90) from lots T600392, T600384, and T600353 (Exp. 8/18), T600427 (Exp. 9/18), T600435 (Exp. 10/18), T600492 (Exp. 11/18), and T700006, T700014, T700033, T700035, and T700036 (Exp. 12/18); and
• 40-mg tablets packaged in 500-count bottles (NDC 55111-123-05) from lot T600407 (Exp. 9/18).

A Class III recall designation suggests use of affected tablets is not likely to cause harm.

—Jolynn Tumolo

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