Drug product
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06
D-0100-2023
Product summary
- Event
- Event 91295
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,056 30 count bottles
- Official record key
drug-enforcement:D-0100-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Code information: Lot # A200171, Exp 12/2023
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications