Olympia Pharmacy recalls specific multi-dose vials of Papaverine, Phentolamine, and Alprostadil due to improper investigation of environmental and personnel monitoring deviations before October 2021. This affects certain lots with specific 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 specific multi-dose vials of Papaverine, Phentolamine, and Alprostadil that were manufactured with improper investigation of environmental and personnel monitoring deviations before October 2021. This recall affects patients using these medications under a prescription.
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 potentially lead to unsafe medication conditions, though the exact risk to patients is not clearly specified in the recall notice.
Prescription patients using the recalled vials for medical treatment. Those with the specific lot numbers and expiration dates listed in the recall notice are most at risk.
Check for the vial label with 'ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial'. Look for lot numbers F41C21 (BUD: 6/21/2022), G42013 (BUD: 7/13/2022), H41C31 (BUD: 8/31/2022), or F41D21 (BUD: 6/21/2022).
Look for the specific product name and lot numbers listed in the recall notice to confirm if your vial is affected.
Olympia Pharmacy is recalling specific multi-dose vials of Papaverine, Phentolamine, and Alprostadil due to improper investigation of environmental and personnel monitoring deviations before October 2021.
Check for the vial label with 'ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial' and lot numbers F41C21 (BUD: 6/21/2022), G42013 (BUD: 7/13/2022), H41C31 (BUD: 8/31/2022), or F41D21 (BUD: 6/21/2022).
The recall notice does not specify a remedy or action to take, so there is no instruction to stop using the vial.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0810-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0810-2022 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.
