Recall: D-0726-2022

Class III - Minor Violations

Class IIIClassification

2022-03-16Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

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

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

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.