CISATRACURIUM BESYLATE
Generic: CISATRACURIUM BESYLATE
Zydus Lifesciences LimitedManufacturer
INTRAVENOUSRoute
CISATRACURIUM BESYLATEActive Substance
2019-11-04Original Approval
CISATRACURIUM BESYLATE is FDA application ANDA212171, sponsored by ZYDUS PHARMS. 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 III2025-11-26
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, ManufaSubpotent product:out of specification assay results observed during long term stability testing.
Class III2025-11-26
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, ManufacturSubpotent product:out of specification assay results observed during long term stability testing.
Class III2025-11-26
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, ManufactureSubpotent product:out of specification assay results observed during long term stability testing.
Class I2021-01-27
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 xLabeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten
Top Reported Reactions
1
ANAESTHETIC COMPLICATION NEUROLOGICAL
110 reports
2
ANAPHYLACTIC SHOCK
57 reports
3
HYPOTENSION
30 reports
4
DRUG INEFFECTIVE
27 reports
5
TOXIC EPIDERMAL NECROLYSIS
24 reports
6
HYPOXIA
23 reports
7
HYPERTHERMIA MALIGNANT
21 reports
8
CYANOSIS
18 reports
9
HYPOKALAEMIA
17 reports
10
TACHYCARDIA
17 reports