FDA recall D-0139-2024

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-11-01

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

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