Drug product
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
D-1057-2020
Product summary
- Event
- Event 85273
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,816 botlles
- Official record key
drug-enforcement:D-1057-2020
Official wording
Reason: Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Code information: Lot # 3105410, 3106268, Exp 9/2020
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablet