Olympia Pharmacy recalls Sincalide lyophilized powder for reconstitution with NDC 73198-0082-00 due to improper investigation of environmental and personnel monitoring deviations before October 2021.
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 Sincalide lyophilized powder for reconstitution (5 mcg per multi-dose vial) because manufacturing monitoring issues were not properly investigated before October 2021. This recall affects patients using the medication under prescription.
The recall is due to environmental and personnel monitoring deviations that were not properly investigated before October 2021. This could potentially lead to unsafe medication quality, but the specific risk to patients is not clearly described in the recall notice.
Patients with prescriptions for Sincalide from Olympia Pharmacy in Orlando, Florida. Those using the medication without a prescription are not affected.
Check for the product name 'Sincalide', lyophilized powder for reconstitution, 5 mcg per multi-dose vial, with NDC 73198-0082-00. The product was sold by Olympia Pharmacy in Orlando, Florida with lots F24018 (BUD: 6/18/2022) and G47021 (BUD: 7/21/2022).
Look for the NDC code 73198-0082-00 on the product label to confirm it is part of this recall.
The recall notice does not specify if the product is safe to use; it mentions manufacturing monitoring issues that were not properly investigated.
Check for the NDC code 73198-0082-00 on the product label, and look for the lots F24018 (BUD: 6/18/2022) or G47021 (BUD: 7/21/2022).
The recall notice does not specify a remedy; you should contact Olympia Pharmacy directly for guidance.
We’ve drafted a message you can send Olympia Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0827-2022 — Olympia Pharmacy Olympia Pharmacy Hello, I own a Olympia Pharmacy that is covered by recall D-0827-2022 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.
