Class I - Dangerous
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class I - Dangerous
Superpotent Drug.
Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20.
GE Healthcare Inc. Life Sciences
Class I - Dangerous
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
Asclemed USA Inc.
Class I - Dangerous
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Class I - Dangerous
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Class I - Dangerous
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Class I - Dangerous
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Class I - Dangerous
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class I - Dangerous
Labeling: Wrong bar code
Class I - Dangerous
Failed Dissolution Specifications.
Class I - Dangerous
Sub-potent
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class I - Dangerous
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Class I - Dangerous
Superpotent Drug: contains higher levels of Iron than labeled.
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Mylan Laboratories Limited, (Nashik FDF)
Class I - Dangerous
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class I - Dangerous
cGMP violations noted during the firm's most recent inspection.
Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Mylan Laboratories Limited, (Nashik FDF)
Class I - Dangerous
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class I - Dangerous
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.