Key Takeaway

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05 by Dr. Reddy's Laboratories, Inc. was recalled on January 29, 2018. The hazard: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

FDA Drug Class III Terminated

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

Recalled: January 29, 2018 ~a) 34,125; b) 3,540 bottles units affected D-0418-2018

Description

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

Hazard / Reason

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

Drugs

Company Information

Dr. Reddy's Laboratories, Inc.

Bridgewater, NJ, United States

View all 163 recalls by Dr. Reddy's Laboratories, Inc. →

Distribution

Nationwide

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Frequently Asked Questions

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