FDAMarch 13, 2020drug
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
What to do
FDA enforcement status: Terminated
Brands named
medical center pharmacymedicalmedical center
UPCs
67457051805
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAGSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.2026-05-29
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- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
- FDABicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;2026-05-12
- FDALidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.2026-05-12
- FDABrand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membra...2026-05-11
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