Recalls / Class II
Class IID-0165-2023
Product
Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)
- Brand name
- Rifampin
- Generic name
- Rifampin
- Active ingredient
- Rifampin
- Route
- Oral
- NDCs
- 60687-575, 60687-586
- FDA application
- ANDA090034
- Affected lot / code info
- Lot #: 1007805, exp. 12/31/2023
Why it was recalled
Failed Impurities/Degradations Specifications
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, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 3,091 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-12-20
- FDA classified
- 2023-01-18
- Posted by FDA
- 2023-01-25
- Terminated
- 2024-09-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0165-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.