DIAZEPAM

Generic: DIAZEPAM

Teva Pharmaceuticals USAManufacturer
ORALRoute
DIAZEPAMActive Substance
1986-12-10Original Approval

DIAZEPAM is FDA application ANDA071307, sponsored by IVAX SUB TEVA PHARMS. 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 II2013-02-26
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, ND

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Class III2018-07-10
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating

Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expi

Class II2013-08-16
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc.

Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the

Class II2016-06-23
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32

Crystallization: Product contains particulate identified to be crystallized active ingredient.

Class II2012-06-06
Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors

Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradati

Class II2012-08-28
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, ND

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Class II2013-05-16
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, ND

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Top Reported Reactions

1
TOXICITY TO VARIOUS AGENTS
8,870 reports
2
DRUG ABUSE
6,138 reports
3
DRUG INEFFECTIVE
4,967 reports
4
NAUSEA
4,147 reports
5
COMPLETED SUICIDE
3,842 reports
6
DRUG INTERACTION
3,774 reports
7
FATIGUE
3,773 reports
8
SOMNOLENCE
3,561 reports
9
OFF LABEL USE
3,480 reports
10
ANXIETY
3,361 reports