Olympia Pharmacy recalls 10mL multi-dose vials of FA, Papaverine, Phentolamine, Alprostadil, and Atropine due to improper investigation of environmental and personnel monitoring deviations before October 2021. No specific action steps provided in recall notice.
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 specific multi-dose vial product containing several medications because of manufacturing monitoring issues. This recall is related to improper investigation of environmental and personnel monitoring deviations that occurred before October 2021.
The recall is due to improper investigation of environmental and personnel monitoring deviations that occurred before October 2021. These deviations could potentially lead to unsafe medication conditions if not properly addressed.
Patients with prescriptions for these medications from Olympia Pharmacy in Orlando, Florida are affected. Those who have the specific vial products with the listed lot numbers and expiration dates are at risk.
Check for the vial products labeled with the specific medications: FA, Papaverine 20 mg/mL, Phentolamine 2 mg/mL, Alprostadil 20 mcg/mL, and Atropine 0.2 mg/mL. Look for lot numbers F41414, F41C14, I24E28, or I24F28 with expiration dates of June 14, 2022, or September 28, 2022.
Identify the specific medications and lot numbers on the vial to determine if it is part of the recall.
The recall is due to improper investigation of environmental and personnel monitoring deviations that occurred before October 2021.
The recall includes multi-dose vials containing FA, Papaverine 20 mg/mL, Phentolamine 2 mg/mL, Alprostadil 20 mcg/mL, and Atropine 0.2 mg/mL.
The recall notice does not specify a remedy or action steps, so there is no instruction to stop using the medication.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0816-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0816-2022 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.
