FDA-Drug2022-04-13Class II
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.
Vitae Enim Vitae Scientific, Inc.
Hazard
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Sold states
Nationwide in the U.S.A
Affected count
a) 2,098 boxes; b) 700 boxes
Manufactured in
3030 Bunker Hill St Ste 203, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0742-2022Don't want to check this manually?
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