Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Eac
Summary
The FDA issued a Class III for Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropin by Olympia Compounding Pharmacy dba Olympia Pharmacy. Reason: Sub Potent.
Details
Source
Drug Recall
External ID
D-0720-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
Product Description
Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10
Lot/Code Info: Lot: D41C19 Exp. 4/19/22
Quantity Affected: 493 vials.
Reason for Recall
Sub 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-0720-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22