Recalls / Class III
Class IIID-0813-2021
Product
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
- Brand name
- Sirolimus
- Generic name
- Sirolimus
- Active ingredient
- Sirolimus
- Route
- Oral
- NDC
- 68084-915
- FDA application
- ANDA201578
- Affected lot / code info
- Lot #: 1000789, Exp. Date 10/31/2022
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 290 cartons
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2021-05-12
- FDA classified
- 2021-09-20
- Posted by FDA
- 2021-09-29
- Terminated
- 2022-08-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0813-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.