Drug product
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
D-0284-2024
Product summary
- Event
- Event 93753
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165,60 bottles
- Official record key
drug-enforcement:D-0284-2024
Official wording
Reason: Subpotent Drug and Failed Impurities/Degradation Specifications
Code information: A200817 exp 1/2024
Distribution pattern: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Derived failure modes
-
Potency or specification failure
Subpotent