Recalls / Class II
Class IID-0742-2022
Product
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.
- Brand name
- Papaverine Hydrochloride
- Generic name
- Papaverine Hydrochloride
- Active ingredient
- Papaverine Hydrochloride
- Route
- Intravenous
- NDC
- 72516-024
- Affected lot / code info
- Lot #: a) 20VPHI037, 20VPHI038, 20VPHI039, Exp 12/31/2022; 21VPHI021, 21VPHI022, 21VPHI023, Exp 6/30/2023; 21VPHI047, 21VPHI048, Exp 10/31/2023; b) 21VPHI023, Exp 6/30/2023
Why it was recalled
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recalling firm
- Firm
- Vitae Enim Vitae Scientific, Inc.
- Manufacturer
- Oryza Pharmaceuticals Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3030 Bunker Hill St Ste 203, San Diego, California 92109-5754
Distribution
- Quantity
- a) 2,098 boxes; b) 700 boxes
- Distribution pattern
- Nationwide in the U.S.A
Timeline
- Recall initiated
- 2022-03-14
- FDA classified
- 2022-04-05
- Posted by FDA
- 2022-04-13
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0742-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.