Recalling firm
Padagis US LLC
Product type
Drug
Status
Ongoing
Report date
2023-12-13
Distribution
Nationwide in the USA
Firm state
MN
Product quantity
7,032 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
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
Code / lot info
Lot: 231104, 231105, 231106, exp 7/31/2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.