D-1047-2020 Class II Terminated
FDA drug recall D-1047-2020 was initiated by Sun Pharmaceutical Industries, Inc. on March 9, 2020 and is designated Class II. Reason for recall: Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg. The recall status is terminated (terminated February 9, 2021). Affected quantity: 1416 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2020
- Initiation Date
- March 9, 2020
- Termination Date
- February 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1416 bottles
Product Description
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
Reason for Recall
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot#: AA33617, Exp 03/2021