Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

FDA recall notice · announced June 27, 2018 · Dr. Reddy's Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: a) T600392, T600384, T600353, Exp 08/18; T600427, Exp 09/18; T600435, Exp 10/18; T600492, Exp 11/18; T700006, T700014, T700033, T700035, T700036 12/18; b) T600407, Exp 09/18
Quantity: 130,081 bottles
Status: Terminated
Products in this recall event:
- Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90 (D-0887-2018)
- Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90 (D-0886-2018)
- Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 (D-0888-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.