Recalls / Class II
Class IID-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
- Brand name
- Trospium Chloride
- Generic name
- Trospium Chloride
- Active ingredient
- Trospium Chloride
- Route
- Oral
- NDC
- 0574-0118
- FDA application
- ANDA201291
- Affected lot / code info
- Lot: 231104, 231105, 231106, exp 7/31/2025
Why it was recalled
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Recalling firm
- Firm
- Padagis US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3940 Quebec Ave N, Minneapolis, Minnesota 55427-1244
Distribution
- Quantity
- 7,032 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-01
- FDA classified
- 2023-12-05
- Posted by FDA
- 2023-12-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0139-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.