PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: December 13, 2023 Initiated: November 1, 2023 #D-0139-2024

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

Details

Recalling Firm
Padagis US LLC
Units Affected
7,032 bottles
Distribution
Nationwide in the USA
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
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. Recalled by Padagis US LLC. Units affected: 7,032 bottles.
Why was this product recalled?
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Which agency issued this recall?
This recall was issued by the FDA Drug on December 13, 2023. Severity: Moderate. Recall number: D-0139-2024.