Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured...
FDA Recall #D-0139-2024 — Class II — November 1, 2023
Product Description
Trospium 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
Reason for Recall
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Recalling Firm
Padagis US LLC — Minneapolis, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7,032 bottles
Distribution
Nationwide in the USA
Code Information
Lot: 231104, 231105, 231106, exp 7/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated