TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks
Summary
The FDA issued a Class II for TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon C by Vita Pharmacy, LLC dba Talon Compounding Pharmacy. Reason: Lack of assurance of sterility.
Details
Source
Drug Recall
External ID
D-0220-2022
Action Date
2021-11-17
Status
Terminated
Category
drug
Product Description
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Lot/Code Info: Lot: 06232021:24 BUD: 10/23/2021; 07192021:69 BUD: 01/15/2022; 09132021:87 BUD: 03/12/2022; 07282021:91 BUD: 01/24/2022; 04162021:06 BUD: 10/13/2021
Quantity Affected: 13 vials
Reason for Recall
Lack of assurance of sterility
Distribution
United States including Washington, D.C. and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-12
Company
San Antonio, TX
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 163 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy has 130 FDA actions in our database, including 130 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 (Vita Pharmacy, LLC dba Talon Compounding Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vita Pharmacy, LLC dba Talon Compounding Pharmacy have FDA actions?
Vita Pharmacy, LLC dba Talon Compounding Pharmacy has 130 FDA actions in our database, including 130 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0220-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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