Class I - Dangerous
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Class I - Dangerous
Presence of foreign substance: small metallic particles in chewable tablets.
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
AVEVA Drug Delivery Systems
Class I - Dangerous
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Class I - Dangerous
Failed Stability Specifications
Class I - Dangerous
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
IntegraDose Compounding Services
Class I - Dangerous
Subpotent Drug
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
Zydus Pharmaceuticals (USA)
Class I - Dangerous
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class I - Dangerous
Presence of particulate matter: a white thread-like structure in the cartridge
Class I - Dangerous
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Amerisource Health Services
Class I - Dangerous
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.