Drug product
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
D-1343-2022
Product summary
- Event
- Event 90616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,872/30 count bottles
- Official record key
drug-enforcement:D-1343-2022
Official wording
Reason: CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Code information: Lot #A200170, exp. date December 2023
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations