Padagis US LLC
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Padagis US LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-05FDA-DrugClass IIEstradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
- 2024-11-27FDA-DrugClass IIITriamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
- 2023-12-13FDA-DrugClass IITrospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
- 2023-11-08FDA-DrugClass IIGynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
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