D-0219-2024 Class II Terminated
FDA drug recall D-0219-2024 was initiated by Dr. Reddy's Laboratories, Inc. on December 15, 2023 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules. The recall status is terminated (terminated September 16, 2024). Affected quantity: 8,280 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 17, 2024
- Initiation Date
- December 15, 2023
- Termination Date
- September 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,280 bottles
Product Description
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
Reason for Recall
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Distribution Pattern
US Nationwide.
Code Information
Lot# C2307275; Exp. January 2026