Drug product
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
D-0219-2024
Product summary
- Event
- Event 93622
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,280 bottles
- Official record key
drug-enforcement:D-0219-2024
Official wording
Reason: Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Code information: Lot# C2307275; Exp. January 2026
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets