METHADONE HYDROCHLORIDE
Generic: METHADONE HYDROCHLORIDE
Elite LaboratoriesManufacturer
ORALRoute
METHADONE HYDROCHLORIDEActive Substance
2018-08-02Original Approval
METHADONE HYDROCHLORIDE is FDA application ANDA210484, sponsored by ELITE LABS INC. 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 III2024-12-19
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA IFailed Tablet/Capsule Specifications: Illegible product identification for the unit dose configurati
Class II2017-01-18
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx onlyCGMP Deviations: Purified water used to manufacture the drug products may have been contaminated wit
Class II2017-01-18
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-6CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated wit
Top Reported Reactions
1
DRUG DEPENDENCE
5,646 reports
2
TOXICITY TO VARIOUS AGENTS
5,301 reports
3
DRUG ABUSE
4,917 reports
4
OVERDOSE
3,892 reports
5
PAIN
3,699 reports
6
DEATH
3,593 reports
7
EMOTIONAL DISTRESS
2,387 reports
8
DRUG WITHDRAWAL SYNDROME
2,370 reports
9
DRUG INEFFECTIVE
1,766 reports
10
FOETAL EXPOSURE DURING PREGNANCY
1,680 reports