D-0629-2021 Class III Terminated
FDA drug recall D-0629-2021 was initiated by Dr. Reddy's Laboratories, Inc. on June 4, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities The recall status is terminated (terminated February 16, 2023). Affected quantity: 5984 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 23, 2021
- Initiation Date
- June 4, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5984 bottles
Product Description
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
Reason for Recall
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: C905064, C905065, Exp. Date 07/2021