Status
Terminated
Drug Enforcement D-0098-2023
Failed Impurities/Degradation specifications
Classification
Class II
Report Date
January 18, 2023
Termination Date
March 3, 2023
Product Information
- Product description
- 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.
- Product quantity
- 132 Cards of 30 = 3960 Tablets
- Reason for recall
- Failed Impurities/Degradation specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to one account in PA.
Location & Firm
- Recalling firm
- RemedyRepack Inc.
- Address
-
625 Kolter Dr Ste 4
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0098-2023
- Event ID
- 91345
- Recall initiation date
- December 20, 2022
- Center classification date
- January 6, 2023
- Code info
- Lot #: J0599794-022322, exp. date 02/28/2023; J0621369-052622, exp. date 06/30/2023
- More code info
- —