Drugplain

VENLAFAXINE 75 mg/1

VENLAFAXINE · TABLET · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

10 Recalls on Record
Plain English

VENLAFAXINE is a tablet containing venlafaxine at 75 mg/1, taken oral. Manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..

Key Facts

Brand Name
VENLAFAXINE
Generic Name
VENLAFAXINE
NDC Code (Product)
23155-249
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Strength
75 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA078554
Marketing Start
07/19/2021

Recall History

10 Recalls on Record
Class II03/20/2014

Caraco Pharmaceutical Laboratories, Ltd.

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

TerminatedVoluntary: Firm initiated
Class II07/19/2016

Zydus Pharmaceuticals USA Inc

Failed Dissolution Specifications: out of specification dissolution results in retained samples

TerminatedVoluntary: Firm initiated
Class II03/20/2014

Caraco Pharmaceutical Laboratories, Ltd.

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

TerminatedVoluntary: Firm initiated
Class II03/21/2025

Zydus Pharmaceuticals (USA) Inc

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

CompletedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; VENLAFAXINE Tablet, 25 mg may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD65457_22, EXP: 5/24/2014.

TerminatedVoluntary: Firm initiated
Class II06/12/2014

Caraco Pharmaceutical Laboratories, Ltd.

Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 25 mg may have potentially been mislabeled as one of the following drugs: sitaGLIPtin PHOSPHATE, Tablet, 50 mg, NDC 00006011231, Pedigree: W002824, EXP: 6/7/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: W003847, EXP: 6/27/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD62796_1, EXP: 5/22/2014.

TerminatedVoluntary: Firm initiated
Class II09/26/2014

Sun Pharma Global Inc.

Failed Dissolution Specifications; 12 month stability time point

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II08/03/2016

Golden State Medical Supply Inc.

Failed Dissolution Specifications: Out-of-specification results in retained sample.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective5,624 reports
nausea4,441 reports
toxicity to various agents4,361 reports
fatigue4,284 reports
off label use4,258 reports
headache3,805 reports
completed suicide3,295 reports
drug interaction3,152 reports
dizziness3,074 reports
diarrhoea2,844 reports

Frequently Asked Questions

What is VENLAFAXINE used for?

VENLAFAXINE contains VENLAFAXINE. It is a tablet taken oral. Consult your doctor for specific uses.

Is VENLAFAXINE a controlled substance?

VENLAFAXINE is not classified as a controlled substance by the DEA.

What is the generic name for VENLAFAXINE?

The generic name for VENLAFAXINE is VENLAFAXINE. There are 11 other brand versions of VENLAFAXINE.

What is the NDC code for VENLAFAXINE 75 mg/1?

The NDC (National Drug Code) for VENLAFAXINE 75 mg/1 is 23155-249, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..