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.
Reported: April 13, 2022 Initiated: March 14, 2022 #D-0742-2022
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.
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.
Details
- Recalling Firm
- Vitae Enim Vitae Scientific, Inc.
- Units Affected
- a) 2,098 boxes; b) 700 boxes
- Distribution
- Nationwide in the U.S.A
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Vitae Enim Vitae Scientific, Inc.. Units affected: a) 2,098 boxes; b) 700 boxes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2022. Severity: Moderate. Recall number: D-0742-2022.
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