BUPRENORPHINE HYDROCHLORIDE

Generic: BUPRENORPHINE HYDROCHLORIDE

Advagen Pharma LtdManufacturer
SUBLINGUALRoute
BUPRENORPHINE HYDROCHLORIDEActive Substance
2015-06-10Original Approval

BUPRENORPHINE HYDROCHLORIDE is FDA application ANDA090279, sponsored by RUBICON RESEARCH. 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 II2020-09-04
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by

Failed Stability Specifications: Below specification result for buprenorphine release rate.

Class III2026-08-19
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, C

Labeling: Label Mix-up

Class II2023-05-03
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

CGMP Deviations

Class II2021-02-26
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvo

Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

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 II2022-10-18
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical

Presence of Foreign Substance

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.

Top Reported Reactions

1
DRUG DEPENDENCE
4,328 reports
2
OVERDOSE
3,430 reports
3
DEPENDENCE
2,414 reports
4
DRUG ABUSE
2,296 reports
5
PAIN
2,275 reports
6
DEATH
1,955 reports
7
DRUG INEFFECTIVE
1,910 reports
8
TOXICITY TO VARIOUS AGENTS
1,836 reports
9
NAUSEA
1,619 reports
10
DRUG WITHDRAWAL SYNDROME
1,486 reports