Drug product
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
D-0330-2023
Product summary
- Event
- Event 91661
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,320 bottles
- Official record key
drug-enforcement:D-0330-2023
Official wording
Reason: Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Code information: Lot # C2106445; Exp. 03/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets