D-0599-2021 Class III Terminated
FDA drug recall D-0599-2021 was initiated by Dr. Reddy's Laboratories, Inc. on May 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: 2980 500 count -bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- May 4, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2980 500 count -bottles
Product Description
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, 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
Distributed Nationwide in the USA
Code Information
Lot # C905063, Exp 07/2021