THIAMINE HYDROCHLORIDE

Generic: THIAMINE HYDROCHLORIDE

Mylan Institutional LLCManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
THIAMINE HYDROCHLORIDEActive Substance
2012-06-25Original Approval

THIAMINE HYDROCHLORIDE is FDA application ANDA091623, sponsored by MYLAN INSTITUTIONAL. 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 III2021-05-03
Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx onl

Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 conta

Top Reported Reactions

1
OFF LABEL USE
519 reports
2
PAIN
442 reports
3
NAUSEA
435 reports
4
DRUG INEFFECTIVE
409 reports
5
DYSPNOEA
381 reports
6
FATIGUE
368 reports
7
DIARRHOEA
342 reports
8
CONDITION AGGRAVATED
316 reports
9
HEADACHE
310 reports
10
DRUG HYPERSENSITIVITY
292 reports