Recall: D-0139-2024

Class II - Potentially Harmful

Class IIClassification

2023-11-01Initiated

OngoingStatus

Padagis US LLCFirm

Product

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.