Padagis US LLC recalls
7 recalls on record · FDA
Every recall we have on record for Padagis US LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only,…
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By…
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only,…
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled…
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1…
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo,…
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx…
Defective Delivery System