Olympia Pharmacy recalls QM-4 multi-dose vials due to improper investigation of environmental and personnel monitoring failures before October 2021. Affected vials have specific lot numbers and expiration dates.
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 QM-4 multi-dose vials that contain papaverine, phentolamine, alprostadil, and atropine. The recall is due to improper investigation of environmental and personnel monitoring failures before October 2021, which could lead to contamination risks.
The recall is triggered by CGMP deviations where environmental and personnel monitoring failures were not properly investigated before October 2021. This could result in contamination of the vial contents, posing a risk to patients using the medication.
Patients prescribed this multi-dose vial for medical use are affected. Healthcare providers who dispensed the vials are most at risk due to potential contamination.
Check for the QM-4 vial with specific lot numbers: E41027 (BUD: 5/27/2022) or I24E13 (BUD: 9/13/2022). The vial is labeled as Rx Only and contains papaverine, phentolamine, alprostadil, and atropine.
Identify the lot number on the vial (E41027 or I24E13) and expiration date (BUD: 5/27/2022 or 9/13/2022).
The official recall notice does not state whether the product is safe to use. The vial has been recalled due to CGMP deviations.
The recall record does not specify a remedy. You should contact Olympia Pharmacy directly for guidance.
Check the lot number on the vial: E41027 (BUD: 5/27/2022) or I24E13 (BUD: 9/13/2022).
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0812-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0812-2022 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.
