FDA-Drug2023-12-13Class II

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

Padagis US LLC
Hazard

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Sold states
Nationwide in the USA
Affected count
7,032 bottles
Manufactured in
3940 Quebec Ave N, Minneapolis, MN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0139-2024

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