CARBAMAZEPINE
Generic: CARBAMAZEPINE
Bionpharma Inc.Manufacturer
ORALRoute
CARBAMAZEPINEActive Substance
2024-02-16Original Approval
CARBAMAZEPINE is FDA application ANDA218221, sponsored by BIONPHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2026-08-07
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-CGMP deviations: tablets with black specks.
Class II2021-12-02
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. BhaFailed Dissolution Specifications
Class II2020-05-11
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LtdFailed Dissolution Specifications
Class II2025-09-15
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American HealFailed Dissolution Specifications.
Top Reported Reactions
1
DRUG INEFFECTIVE
3,503 reports
2
DRUG INTERACTION
2,442 reports
3
TOXICITY TO VARIOUS AGENTS
2,284 reports
4
SEIZURE
1,968 reports
5
OFF LABEL USE
1,859 reports
6
FALL
1,856 reports
7
DIZZINESS
1,494 reports
8
FATIGUE
1,386 reports
9
PAIN
1,386 reports
10
PYREXIA
1,368 reports