Olympia Pharmacy recalls a multi-dose vial of Papaverine, Phentolamine, and Alprostadil due to improper investigation of environmental and personnel monitoring deviations before October 2021. This affects specific lots and batch numbers.
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 a multi-dose vial containing Papaverine, Phentolamine, and Alprostadil because of manufacturing issues. The recall is due to improper investigation of environmental and personnel monitoring deviations that occurred before October 2021. This affects specific lots and batch numbers.
The recall is due to CGMP deviations where environmental and personnel monitoring out-of-action limits were not properly investigated before October 2021. This could lead to improper drug quality if not addressed, though the exact risk to patients is not specified in the recall notice.
Patients prescribed this medication by a doctor are affected. Those with the specific lot numbers H24F03 or H24E03 (BUD: 8/3/2022) are most at risk.
Check for the product name: ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial. Look for lot numbers H24F03 or H24E03 with a batch expiration date of 8/3/2022.
Identify the lot number and batch expiration date on the vial label.
The recall notice does not specify if the medication is safe to use; it indicates a manufacturing issue that requires investigation.
The recall notice does not provide specific action steps for affected individuals.
Check the lot number on the vial label; affected lots are H24F03 or H24E03 with a batch expiration date of 8/3/2022.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0809-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0809-2022 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.
