Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot: 231104, 231105, 231106, exp 7/31/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0139-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 1, 2023
- FDA report date
- Dec 13, 2023
- Quantity
- 7,032 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Padagis US LLC
Original FDA data
Every field from FDA enforcement report D-0139-2024, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 93345
- Address
- 3940 Quebec Ave N
- Code information
- Lot: 231104, 231105, 231106, exp 7/31/2025
- Postal code
- 55427-1244
- Report date
- Dec 13, 2023
- Product type
- Drugs
- Recall number
- D-0139-2024
- Classification
- Class II
- Recalling firm
- Padagis US LLC
- Product quantity
- 7,032 bottles
- Reason for recall
- Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 1, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 5, 2023