Olympia Pharmacy recalls phenylephrine 1 mg/mL vials due to past CGMP monitoring failures. Affected lots from October 2021 to August 2022 may pose safety risks.
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 phenylephrine 1 mg/mL, 5 mL multi-dose vials that were manufactured before October 2021. This recall is due to past failures in monitoring environmental and personnel safety, which could lead to unsafe drug conditions.
The recall is based on past CGMP monitoring failures where environmental and personnel safety checks did not properly investigate out-of-action limit excursions. This could mean the vials were not safe during production.
Prescription drug users who received phenylephrine vials from Olympia Pharmacy before October 2021. People using these vials for medical purposes are most at risk.
Check for the lot number H47030 with a best-by date of August 30, 2022. The product is a phenylephrine 1 mg/mL, 5 mL multi-dose vial prescribed by a doctor.
Look for the lot number H47030 and best-by date of August 30, 2022 on the vial label.
The recall is due to past CGMP monitoring failures where environmental and personnel safety checks did not properly investigate out-of-action limit excursions.
The official notice does not specify a remedy or action for affected products.
The official notice does not describe a specific hazard that could cause serious injury.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0822-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0822-2022 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.
