Recalls / Class III
Class IIID-1334-2022
Product
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
- Brand name
- Azacitidine
- Generic name
- Azacitidine
- Active ingredient
- Azacitidine
- Route
- Intravenous, Subcutaneous
- NDC
- 68001-313
- FDA application
- NDA208216
- Affected lot / code info
- Lot: FE22001A, Exp 01/2024
Why it was recalled
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Manufacturer
- BluePoint Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 4162 cartons
- Distribution pattern
- Distributed in Ohio
Timeline
- Recall initiated
- 2022-07-22
- FDA classified
- 2022-08-11
- Posted by FDA
- 2022-08-17
- Terminated
- 2023-04-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1334-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.