D-0888-2018 Class III Terminated
FDA drug recall D-0888-2018 was initiated by Dr. Reddy's Laboratories, Inc. on Jun 12, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Nov 8, 2019). Affected quantity: 130,081 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 27, 2018
- Initiation Date
- Jun 12, 2018
- Termination Date
- Nov 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130,081 bottles
Product Description
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
Distribution Pattern
Nationwide in the USA and Puerto Rico
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0888-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026