Recalls / Class II
Class IID-0285-2024
Product
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11
- Brand name
- Rifampin
- Generic name
- Rifampin
- Active ingredient
- Rifampin
- Route
- Oral
- NDCs
- 60687-575, 60687-586
- FDA application
- ANDA090034
- Affected lot / code info
- Lot #: 1008111, Exp. Date 01/31/2024
Why it was recalled
Failed Impurities/Degradation Specification.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 1,568 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-11
- FDA classified
- 2024-01-30
- Posted by FDA
- 2024-02-07
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0285-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.