Drug product
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
D-0098-2023
Product summary
- Event
- Event 91345
- Status
- Terminated
- Classification
- Class II
- Quantity
- 132 Cards of 30 = 3960 Tablets
- Official record key
drug-enforcement:D-0098-2023
Official wording
Reason: Failed Impurities/Degradation specifications
Code information: Lot #: J0599794-022322, exp. date 02/28/2023; J0621369-052622, exp. date 06/30/2023
Distribution pattern: Product was distributed to one account in PA.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation specifications