Drug product
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
D-0268-2023
Product summary
- Event
- Event 91577
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3665 bottles
- Official record key
drug-enforcement:D-0268-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Code information: Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out Of Specification