🍔 Food 💊 Drugs 🏥 Medical Devices
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370 Class II

Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,

MexHealth LLC 20240522 Ongoing
Distributed: US Nationwide
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Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02 Class II

Reason: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

Denison Pharmaceuticals, LLC 20240528 Terminated
Distributed: Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
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Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10 Class III

Reason: Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

Eugia US LLC 20240522 Ongoing
Distributed: USA nationwide.
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Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30 Class II

Reason: Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

Eugia US LLC 20240523 Ongoing
Distributed: USA Nationwide
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Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08 Class I

Reason: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Sagent Pharmaceuticals 20240528 Ongoing
Distributed: Nationwide within the USA.
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Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08 Class I

Reason: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Sagent Pharmaceuticals 20240528 Ongoing
Distributed: Nationwide within the USA.
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Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04 Class III

Reason: Defective Container

Organon Llc 20240528 Ongoing
Distributed: Nationwide in the USA
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Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03 Class III

Reason: Defective Container

Organon Llc 20240528 Ongoing
Distributed: Nationwide in the USA
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Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02 Class III

Reason: Defective Container

Organon Llc 20240528 Ongoing
Distributed: Nationwide in the USA
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Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA Class II

Reason: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

RemedyRepack Inc. 20240531 Terminated
Distributed: Product was distributed to one medical facility.
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