T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL
Summary
The FDA issued a Class III for T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 m by Olympia Compounding Pharmacy dba Olympia Pharmacy. Reason: Super Potent.
Details
Source
Drug Recall
External ID
D-0721-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
Product Description
T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 0.5% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.
Lot/Code Info: Lots: a) E41F10 Exp. 5/10/22; b) E41G10 Exp. 5/10/22
Quantity Affected: 1093 vials
Reason for Recall
Super Potent
Distribution
Nationwide in the USA including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-08
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Olympia Compounding Pharmacy dba Olympia Pharmacy has 94 FDA actions in our database, including 94 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Olympia Compounding Pharmacy dba Olympia Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympia Compounding Pharmacy dba Olympia Pharmacy have FDA actions?
Olympia Compounding Pharmacy dba Olympia Pharmacy has 94 FDA actions in our database, including 94 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0721-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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