Recalls / Class III
Class IIID-1349-2022
Product
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
- Affected lot / code info
- Lot #: FE22001A, Exp. Date 01/2024
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Amerisource Health Services LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 4,160 vials
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2022-07-27
- FDA classified
- 2022-08-17
- Posted by FDA
- 2022-08-24
- Terminated
- 2023-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1349-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.