QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged i
Summary
The FDA issued a Class II for QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/ by Northern VA Compounders PLLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0107-2023
Action Date
2023-01-18
Status
Terminated
Category
drug
Product Description
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Lot/Code Info: Lot#: 11162022@10, Exp 12/31/2022; 12052022@9, Exp 1/19/2023
Quantity Affected: 39 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-30
Company
Sterling, VA
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 72 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Northern VA Compounders PLLC has 25 FDA actions in our database, including 25 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 (Northern VA Compounders PLLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Northern VA Compounders PLLC have FDA actions?
Northern VA Compounders PLLC has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0107-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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