CARBAMAZEPINE Recall D-0365-2022
Description: Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
CARBAMAZEPINE Recall D-0365-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0365-2022 |
Event ID | 89146 |
Brand | CARBAMAZEPINE |
Generic Name | CARBAMAZEPINE |
Manufacturer | CARBAMAZEPINE |
Original Package? | 1 |
Active Substance | CARBAMAZEPINE |
Drug Route | ORAL |
Distribution | Nationwide USA |
Quantity | 15,336 Bottles |
Recall Reason | Failed Dissolution Specifications |
Drug Classification | Class II |
Drug Code Info | 20220119 |
Product NDC | 13668-268 13668-271 |
Product NUI | N0000008486 N0000175751 N0000185506 |
Drug UPC | 0313668268010 0313668271010 |
Pharma Class (PE) | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
Pharma Class (EPC) | Mood Stabilizer [EPC] |
Recall Initiation Date | 20211202 |
Report Date | 20220119 |
Classification Date | 20220111 |
Address | 150 Allen Rd Ste 102 Basking Ridge, NJ 07920-3856 United States |
Recalling Firm | Torrent Pharma Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | 33CM23913M |
Drug Application Number | ANDA077272 |
Structured Product Labeling (SPL ID) | 0e859385-907a-4e87-a1cb-3584b19bd8a1 |
Structured Product Labeling (SPL Set ID) | 97e6e175-75e8-437b-b457-ddb1ae4e857d |
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