BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE

Generic: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE

Accord HealthcareManufacturer
SUBLINGUALRoute
BUPRENORPHINE HYDROCHLORIDEActive Substance
2020-07-17Original Approval

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE is FDA application ANDA209069, sponsored by WES PHARMA 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 II2017-04-28
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials

Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bot

Class II2024-05-20
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Class II2021-11-09
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied i

Crystallization; identified as Buprenorphine free base

Class II2026-03-13
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern

Crystallization; identified as Buprenorphine free base

Class II2020-08-14
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:

Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

Class II2014-09-09
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock,

Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine im

Class II2026-06-12
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intr

Crystallization; identified as Buprenorphine free base

Top Reported Reactions

1
DEPENDENCE
2,275 reports
2
OVERDOSE
1,218 reports
3
DEATH
368 reports
4
FOETAL EXPOSURE DURING PREGNANCY
285 reports
5
DRUG WITHDRAWAL SYNDROME NEONATAL
250 reports
6
MATERNAL EXPOSURE DURING PREGNANCY
240 reports
7
DEPRESSION
229 reports
8
ILL-DEFINED DISORDER
219 reports
9
TOXICITY TO VARIOUS AGENTS
191 reports
10
NAUSEA
185 reports