Drug recall D-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.
Reason for recall
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Lots and codes
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
Recall details
- Recalling firm
- Vitae Enim Vitae Scientific, Inc., San Diego, CA
- Quantity
- a) 2,098 boxes; b) 700 boxes
- Distribution
- Nationwide in the U.S.A
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 14, 2022
- Terminated
- August 15, 2024
Related products
- Papaverine Hydrochloride – drug information
- NDC 72516-024 Papaverine Hydrochloride · Papaverine Hydrochloride 30 mg/mL · Oryza Pharmaceuticals Inc.