Olympia Pharmacy recalls QM-3 vials with CGMP deviations from October 2021. These multi-dose vials may have uninvestigated environmental or personnel monitoring failures. Affected vials have specific NDC and lot 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 QM-3 multi-dose vials that were manufactured before October 2021 due to improper investigation of environmental and personnel monitoring failures. This recall is important because the vials could have been produced under conditions that don't meet current good manufacturing practices.
The vials were produced before October 2021 with CGMP deviations, meaning environmental and personnel monitoring failures were not properly investigated. This could lead to unsafe drug production if the monitoring issues were not addressed.
Patients prescribed QM-3 vials by healthcare providers in the U.S. who received them before October 2021 are affected. Those using the vials for medical treatments are at risk if the vials were not properly monitored.
Check for the NDC 73198-0019-10 label on the vial. Look for lot numbers E42B12, E42C12, E42D12, H24B23, H24C23, or H24D23 with expiration dates up to May 2022 or August 2022.
Identify the NDC 73198-0019-10 and lot numbers E42B12, E42C12, E42D12, H24B23, H24C23, or H24D23 on the vial.
The vials were manufactured before October 2021 with CGMP deviations, meaning environmental and personnel monitoring failures were not properly investigated.
The official recall notice does not specify a remedy or action for affected vials.
Yes, check for lot numbers E42B12, E42C12, E42D12, H24B23, H24C23, or H24D23 with expiration dates up to May 2022 or August 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-0811-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0811-2022 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.
