Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.

FDA recall notice · announced June 2, 2021 · Dr. Reddy's Laboratories

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

The product

Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.

Reason for recall

Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot # C905063, Exp 07/2021
Quantity: 2980 500 count -bottles
Status: Terminated
Products in this recall event:
- Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05. (D-0599-2021)

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