Olympia Pharmacy recalls Diluent for Reconstitution vials due to past CGMP deviations in environmental and personnel monitoring. Affected lots from 2021-2022 may pose safety risks if used improperly.
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 Diluent for Reconstitution vials that were manufactured before October 2021. The recall is due to improper investigation of environmental and personnel monitoring issues that could affect product safety.
The vials were produced before October 2021 and had CGMP deviations where environmental and personnel monitoring issues were not properly investigated. This could lead to potential product contamination or safety issues if the vials are used without proper quality checks.
Patients using this medication under prescription must check if their vial matches the listed lots. Healthcare providers handling the product are most at risk due to the CGMP deviations.
Check for vials labeled with specific lot numbers: D41012 through E48816, with expiration dates from April 2022 through August 2022. The product is only available by prescription.
Look for lot numbers on the vial: D41012, D41212, D47026, E41017, E41018, E47004, E47024, E47026, E48005, G47014, H48816.
The product may pose safety risks due to past CGMP deviations, but it is not immediately dangerous. Affected vials should be checked and disposed of if they match the listed lots.
Check the vial lot number against the list: D41012 through H48816 with expiration dates from April 2022 through August 2022. This product is only available by prescription.
Contact Olympia Pharmacy directly to confirm if your vial is affected and follow their instructions for disposal or return.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0796-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0796-2022 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.
