Class I - Dangerous
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
Denver Solutions, LLC
Class I - Dangerous
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class I - Dangerous
Lack of Assurance of Sterility
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
Denver Solutions, LLC
Class I - Dangerous
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class I - Dangerous
Lack of Assurance of Sterility
Subpotent Drug: Out of specification for assay
Class I - Dangerous
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class I - Dangerous
Lack of Assurance of Sterility
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Class I - Dangerous
CGMP Deviations: Potential Glass and Silicone particulates in product
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Amneal Pharmaceuticals of New York
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class I - Dangerous
CGMP Deviations: Potential Glass and Silicone particulates in product
Class I - Dangerous
CGMP Deviations: Potential Glass and Silicone particulates in product
Class I - Dangerous
CGMP Deviations: Potential Glass and Silicone particulates in product
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01
Mallinckrodt Hospital Products
Class I - Dangerous
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I - Dangerous
CGMP Deviations: Out of specification for residual solvents.
Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Neptune Resources
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I - Dangerous
CGMP Deviations