Drug 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
D-0139-2024
Product summary
- Firm
- Padagis US LLC
- Event
- Event 93345
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,032 bottles
- Official record key
drug-enforcement:D-0139-2024
Official wording
Reason: Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Code information: Lot: 231104, 231105, 231106, exp 7/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules