PlainRecalls
FDA Drug Low Class III Terminated

Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

Reported: April 6, 2022 Initiated: March 16, 2022 #D-0726-2022

Product Description

Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

Reason for Recall

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

Details

Units Affected
28,068 bottles
Distribution
Nationwide in the USA.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 28,068 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 6, 2022. Severity: Low. Recall number: D-0726-2022.