FDAClass IIJune 1, 2022

Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL recall: Sterility Concern

Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals…

Why was Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL 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: A24F19-22 BUD: 1/19/2023

Product
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals…
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Quantity
72 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)
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