D-0726-2022 Class III Terminated
FDA drug recall D-0726-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Mar 16, 2022 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification results for related substance. The recall status is terminated (terminated Nov 13, 2023). Affected quantity: 28,068 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 6, 2022
- Initiation Date
- Mar 16, 2022
- Termination Date
- Nov 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,068 bottles
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: T000707, T000756, T000758, T000759, Exp 03/2022; T2100600, T2101075, Exp. 1/2023; T2102802, Exp. 07/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0726-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026