Drug product
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
D-0813-2021
Product summary
- Event
- Event 88650
- Status
- Terminated
- Classification
- Class III
- Quantity
- 290 cartons
- Official record key
drug-enforcement:D-0813-2021
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 1000789, Exp. Date 10/31/2022
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications