PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 725
Summary
The FDA issued a Class II for PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 by Vitae Enim Vitae Scientific, Inc.. Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended.
Details
Source
Drug Recall
External ID
D-0742-2022
Action Date
2022-04-13
Status
Terminated
Category
drug
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.
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
Quantity Affected: 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.
Distribution
Nationwide in the U.S.A
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-14
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Vitae Enim Vitae Scientific, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vitae Enim Vitae Scientific, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vitae Enim Vitae Scientific, Inc. have FDA actions?
Vitae Enim Vitae Scientific, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0742-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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