Recalls / Class II
Class IID-0098-2023
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.
- Affected lot / code info
- Lot #: J0599794-022322, exp. date 02/28/2023; J0621369-052622, exp. date 06/30/2023
Why it was recalled
Failed Impurities/Degradation specifications
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 132 Cards of 30 = 3960 Tablets
- Distribution pattern
- Product was distributed to one account in PA.
Timeline
- Recall initiated
- 2022-12-20
- FDA classified
- 2023-01-06
- Posted by FDA
- 2023-01-18
- Terminated
- 2023-03-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0098-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.