CYANOCOBALAMIN
Generic: CYANOCOBALAMIN
Zydus Pharmaceuticals USA Inc.Manufacturer
INTRAMUSCULAR, SUBCUTANEOUSRoute
CYANOCOBALAMINActive Substance
2022-04-15Original Approval
CYANOCOBALAMIN is FDA application ANDA214655, 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 II2026-07-24
Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose ViPresence of Particulate Matter: Product contaminated with particulate matter identified as hair, gla
Class II2012-09-27
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II2021-03-15
CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIALCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II2026-07-24
Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, gla
Class III2022-04-05
Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for ASubpotent Drug: Out of Specification results for Assay
Top Reported Reactions
1
FATIGUE
3,305 reports
2
NAUSEA
2,728 reports
3
OFF LABEL USE
2,446 reports
4
HEADACHE
2,361 reports
5
PAIN
2,199 reports
6
DIARRHOEA
2,183 reports
7
DRUG INEFFECTIVE
2,155 reports
8
DYSPNOEA
2,099 reports
9
VOMITING
1,797 reports
10
ARTHRALGIA
1,768 reports