Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0030, NDC 73069-035-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class I - Dangerous
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0184, NDC 73069-164-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0615, NDC 73069-450-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 73069-500-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
Amneal Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
Golden State Medical Supply
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0400, NDC 73069-320-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-024-41.
8046255 Canada Inc.
Class I - Dangerous
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX
First Royal Care Co. LLC
Class I - Dangerous
Lack of Assurance of Sterility
Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.
Green Lumber Holdings
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.