Olympia Pharmacy recalls SB-6 vials (Papaverine 30 mg/mL, Phentolamine 3 mg/mL, PGE 60 mcg/mL) for potential CGMP deviations in environmental and personnel monitoring. Affected vials were sold with 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 SB-6 vials that contain Papaverine, Phentolamine, and PGE. The recall is due to manufacturing monitoring issues that could affect product safety. This is a prescription-only medication, so only authorized healthcare providers should be concerned.
The recall mentions CGMP deviations related to environmental and personnel monitoring not being properly investigated before October 1, 2021. This could mean the vials were not manufactured safely, but the specific risk to users isn't clearly stated.
Prescription-only SB-6 vials purchased from Olympia Pharmacy between certain dates. Healthcare providers who have these vials are most at risk.
Check for vials labeled SB-6 with Papaverine 30 mg/mL, Phentolamine 3 mg/mL, and PGE 60 mcg/mL. Look for lot numbers E41H18 (BUD: 5/18/2022) or G41319 (BUD: 7/19/2022).
Identify the vial by checking for the specific product name and lot numbers listed in the recall notice.
The recall states there were CGMP deviations in monitoring, but the specific risk to users isn't clearly described. The official notice does not confirm if the product is unsafe.
Look for vials labeled SB-6 with Papaverine 30 mg/mL, Phentolamine 3 mg/mL, and PGE 60 mcg/mL, and lot numbers E41H18 (BUD: 5/18/2022) or G41319 (BUD: 7/19/2022).
The recall notice does not specify a remedy, so there is no action required beyond checking if you have the vials.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0808-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0808-2022 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.
