Olympia Pharmacy recalls Formula F2 multi-dose vials due to improper investigation of environmental and personnel monitoring deviations before October 2021. This may affect safety in medical use.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Olympia Pharmacy is recalling Formula F2 multi-dose vials that contain papaverine, phentolamine, alprostadil, and atropine. The recall is due to improper investigation of monitoring deviations that could affect product safety before October 2021.
The recall is based on CGMP deviations where environmental and personnel monitoring issues were not properly investigated before October 2021. This could mean the product was not safe as intended, though the specific risk to users is not clearly described.
Patients prescribed Formula F2 by doctors who received the vials from Olympia Pharmacy between October 2021 and the expiration dates listed on the vials are affected. Those using the product for medical purposes are at risk.
Check for vials labeled 'Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose' from Olympia Pharmacy. Look for lot numbers G48C20 (BUD: 7/20/2022) or G48B20 (BUD: 7/22/2022).
Look for the lot numbers G48C20 (BUD: 7/20/2022) or G48B20 (BUD: 7/22/2022) on the vial label.
The recall does not specify if the product is safe; it was recalled due to monitoring deviations that may affect safety.
Check for vials labeled 'Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose' with lot numbers G48C20 or G48B20.
The recall does not specify a remedy; you should contact Olympia Pharmacy for guidance.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0821-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0821-2022 from Olympia Pharmacy. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
