Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0365-2022
Event ID89146
BrandCARBAMAZEPINE
Generic NameCARBAMAZEPINE
ManufacturerCARBAMAZEPINE
Original Package?1
Active SubstanceCARBAMAZEPINE
Drug RouteORAL
DistributionNationwide USA
Quantity15,336 Bottles
Recall ReasonFailed Dissolution Specifications
Drug ClassificationClass II
Drug Code Info20220119
Product NDC13668-268 13668-271
Product NUIN0000008486 N0000175751 N0000185506
Drug UPC0313668268010 0313668271010
Pharma Class (PE)Decreased Central Nervous System Disorganized Electrical Activity [PE]
Pharma Class (EPC)Mood Stabilizer [EPC]
Recall Initiation Date20211202
Report Date20220119
Classification Date20220111
Address150 Allen Rd Ste 102
Basking Ridge, NJ 07920-3856
United States
Recalling FirmTorrent Pharma Inc.
Initial Notification Letter
Unique Ingredient Identifier33CM23913M
Drug Application NumberANDA077272
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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