Vitae Enim Vitae Scientific, Inc.: Drug Recall
Recall #D-0742-2022 · 03/14/2022
Class II: Risk
Recall Details
- Recall Number
- D-0742-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Vitae Enim Vitae Scientific, Inc.
- Status
- Terminated
- Date Initiated
- 03/14/2022
- Location
- San Diego, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 2,098 boxes; b) 700 boxes
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.
Product Description
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.
Distribution Pattern
Nationwide in the U.S.A
Other Recalls by Vitae Enim Vitae Scientific, Inc.
- Class II: Risk 03/14/2022
- Class II: Risk 03/14/2022
- Class II: Risk 03/14/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.