BUPRENORPHINE AND NALOXONE
Generic: BUPRENORPHINE AND NALOXONE
Mylan Pharmaceuticals Inc.Manufacturer
BUCCAL, SUBLINGUALRoute
BUPRENORPHINE HYDROCHLORIDEActive Substance
2018-06-14Original Approval
BUPRENORPHINE AND NALOXONE is FDA application ANDA207607, sponsored by MYLAN TECHNOLOGIES. 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 II2021-02-26
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: AlvoSubpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class II2022-10-18
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun PharmaceuticalPresence of Foreign Substance
Top Reported Reactions
1
DRUG DEPENDENCE
171 reports
2
NAUSEA
151 reports
3
DRUG INEFFECTIVE
106 reports
4
DRUG WITHDRAWAL SYNDROME
104 reports
5
VOMITING
92 reports
6
HEADACHE
91 reports
7
INJECTION SITE REACTION
91 reports
8
PAIN
90 reports
9
FOETAL EXPOSURE DURING PREGNANCY
85 reports
10
DRUG WITHDRAWAL SYNDROME NEONATAL
82 reports