TROSPIUM CHLORIDE Recall D-0139-2024
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
TROSPIUM CHLORIDE Recall D-0139-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0139-2024 |
| Event ID | 93345 |
| Brand | TROSPIUM CHLORIDE |
| Generic Name | TROSPIUM CHLORIDE |
| Manufacturer | TROSPIUM CHLORIDE |
| Original Package? | 1 |
| Active Substance | TROSPIUM CHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 7,032 bottles |
| Recall Reason | Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules |
| Drug Classification | Class II |
| Drug Code Info | 20231213 |
| Product NDC | 0574-0118 |
| Recall Initiation Date | 20231101 |
| Report Date | 20231213 |
| Classification Date | 20231205 |
| Address | 3940 Quebec Ave N Minneapolis, MN 55427-1244 United States |
| Recalling Firm | Padagis US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 1E6682427E |
| Drug Application Number | ANDA201291 |
| Structured Product Labeling (SPL ID) | 8a1e6330-2aa2-4e32-bbfe-369709d024c7 |
| Structured Product Labeling (SPL Set ID) | 4574f905-a8c5-4732-b934-d1c7f9e708c9 |
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