Olympia Pharmacy recalls T-106 vials due to improper investigation of environmental and personnel monitoring failures before October 2021. These vials contain Papaverine, Phentolamine, and Alprostadil for medical use.
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 T-106 vials that contain Papaverine, Phentolamine, and Alprostadil. The recall is because the pharmacy failed to properly investigate monitoring issues before October 2021, which could affect drug safety.
The recall is due to CGMP (current good manufacturing practice) deviations where environmental and personnel monitoring failures were not properly investigated before October 2021. This could lead to unsafe drug conditions if the vials were used without proper checks.
Patients prescribed T-106 vials by Olympia Pharmacy in the U.S. are affected. Those using the vials for medical treatments are most at risk due to potential contamination.
Check for T-106 vials labeled with NDC numbers 73198-0013-10 (10 mL) or 73198-0013-05 (5 mL). These vials contain Papaverine, Phentolamine, and Alprostadil and are prescription-only.
Identify the NDC numbers: 73198-0013-10 for 10 mL vials or 73198-0013-05 for 5 mL vials.
The recall is due to CGMP deviations where environmental and personnel monitoring failures were not properly investigated before October 2021.
The official notice does not specify a remedy or action for affected products.
The recall indicates potential safety issues due to improper monitoring checks, but the specific risks are not detailed in the notice.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0804-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0804-2022 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.
