Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray recall — FDA D-0652-2022
Impurity failure at 0-time of the repackaged lot.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Impurity failure at 0-time of the repackaged lot.
Failed Dissolution Specifications
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
CGMP deviations
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide,…
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice…
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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