D-1079-2018 Class III Terminated
FDA drug recall D-1079-2018 was initiated by Dr. Reddy's Laboratories, Inc. on Aug 2, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets… The recall status is terminated (terminated Apr 15, 2020). Affected quantity: 2280 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 22, 2018
- Initiation Date
- Aug 2, 2018
- Termination Date
- Apr 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2280 bottles
Product Description
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Reason for Recall
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Distribution Pattern
U.S.A. Nationwide
Code Information
T60045
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1079-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026