FDAClass IIJune 1, 2022

FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil recall: Sterility Concern

FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, 6700 Olympia Pharmaceuticals…

Why was FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil recalled?

Lack of assurance of sterility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: B41C22-22 BUD: 2/22/2023

Product
FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, 6700 Olympia Pharmaceuticals…
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Quantity
1159 vials
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Recall date
June 1, 2022
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls