Greenstone Llc
Product Description:Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Status:Ongoing
City:Peapack
State:NJ
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern:Nationwide and Puerto Rico
Classification:Class I
Product Quantity:16,018 bottles
Reason For Recall:Presence of Foreign Tablets/Capsules: A Pharmacist reported a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule in a lot of Effexor XR 150 mg capsules that was packaged in the same packaging campaign as this Venlafaxine HCl lot.
Recall Initiation Date:20140306
Report Date:20140618
Greenstone Llc
Product Description:Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Status:Ongoing
City:Peapack
State:NJ
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern:Nationwide and Puerto Rico
Classification:Class I
Product Quantity:16,018 bottles
Reason For Recall:Presence of Foreign Tablets/Capsules: A Pharmacist reported a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule in a lot of Effexor XR 150 mg capsules that was packaged in the same packaging campaign as this Venlafaxine HCl lot.
Recall Initiation Date:20140306
Report Date:20140618

Venlafaxine Hydrochloride

Venlafaxine Hydrochloride

Venlafaxine Hydrochloride Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Major Depressive Disorder

Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.

1.2 Generalized Anxiety Disorder

Venlafaxine hydrochloride extended-release is indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.

1.3 Social Anxiety Disorder

Venlafaxine hydrochloride extended-release is indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.

1.4 Panic Disorder

Venlafaxine hydrochloride extended-release is indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.

History

There is currently no drug history available for this drug.

Other Information

Venlafaxine hydrochloride extended-release capsules are for once-a-day oral administration and contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI).

Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:

Chemical Structure

Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.

Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.

Venlafaxine Hydrochloride Manufacturers


  • Proficient Rx Lp
    Venlafaxine Hydrochloride Capsule, Extended Release [Proficient Rx Lp]
  • Proficient Rx Lp
    Venlafaxine Hydrochloride Capsule, Extended Release [Proficient Rx Lp]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Remedyrepack Inc. ]
  • Major Pharmaceuticals
    Venlafaxine Hydrochloride Capsule, Extended Release [Major Pharmaceuticals]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Remedyrepack Inc. ]
  • Proficient Rx Lp
    Venlafaxine Hydrochloride Capsule, Extended Release [Proficient Rx Lp]
  • Direct Rx
    Venlafaxine Hydrochloride Capsule, Coated, Extended Release [Direct Rx]
  • Direct Rx
    Venlafaxine Hydrochloride Capsule, Extended Release [Direct Rx]
  • Sun Pharma Global Fze
    Venlafaxine Hydrochloride Tablet, Extended Release [Sun Pharma Global Fze]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Kaiser Foundation Hospitals
    Venlafaxine Hydrochloride Capsule, Extended Release [Kaiser Foundation Hospitals]
  • Caraco Pharmaceutical Laboratories, Ltd.
    Venlafaxine Hydrochloride Tablet [Caraco Pharmaceutical Laboratories, Ltd.]
  • Sun Pharma Global Inc.
    Venlafaxine Hydrochloride Tablet, Extended Release [Sun Pharma Global Inc.]
  • St. Marys Medical Park Pharmacy
    Venlafaxine Hydrochloride Tablet [St. Marys Medical Park Pharmacy]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Remedyrepack Inc. ]
  • Stat Rx Usa Llc
    Venlafaxine Hydrochloride Tablet [Stat Rx Usa Llc]
  • Physicians Total Care, Inc.
    Venlafaxine Hydrochloride Tablet, Extended Release [Physicians Total Care, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Venlafaxine Hydrochloride Capsule, Extended Release [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • H.j. Harkins Company, Inc.
    Venlafaxine Hydrochloride Tablet [H.j. Harkins Company, Inc.]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Tablet, Extended Release [Remedyrepack Inc. ]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Venlafaxine Hydrochloride Tablet, Extended Release [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Rebel Distributors Corp.
    Venlafaxine Hydrochloride Tablet [Rebel Distributors Corp.]
  • Kaiser Foundation Hospitals
    Venlafaxine Hydrochloride Tablet [Kaiser Foundation Hospitals]
  • Rebel Distributors Corp
    Venlafaxine Hydrochloride Capsule, Extended Release [Rebel Distributors Corp]
  • Pd-rx Pharmaceuticals, Inc.
    Venlafaxine Hydrochloride Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Physicians Total Care, Inc.
    Venlafaxine Hydrochloride Tablet [Physicians Total Care, Inc.]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride (Venlafaxine Hydrochloride ) Capsule, Extended Release [Remedyrepack Inc. ]
  • Rebel Distributors Corp
    Venlafaxine Hydrochloride Tablet [Rebel Distributors Corp]
  • Unit Dose Services
    Venlafaxine Hydrochloride Capsule, Extended Release [Unit Dose Services]
  • Orchid Healthcare (A Division Of Orchid Chemicals & Pharmaceuticals Ltd.)
    Venlafaxine Hydrochloride Capsule, Extended Release [Orchid Healthcare (A Division Of Orchid Chemicals & Pharmaceuticals Ltd.)]
  • Mylan Institutional Inc.
    Venlafaxine Hydrochloride Tablet [Mylan Institutional Inc.]
  • Dr.reddy’s Laboratories Ltd.
    Venlafaxine Hydrochloride Capsule, Extended Release [Dr.reddy’s Laboratories Ltd.]
  • Bryant Ranch Prepack
    Venlafaxine Hydrochloride Capsule, Extended Release [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Venlafaxine Hydrochloride (Venlafaxine) Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Venlafaxine Hydrochloride Capsule, Extended Release [Bryant Ranch Prepack]
  • Cadila Healthcare Limited
    Venlafaxine Hydrochloride Tablet [Cadila Healthcare Limited]
  • Bta Pharmaceuticals
    Venlafaxine Hydrochloride Capsule, Extended Release [Bta Pharmaceuticals]
  • Lake Erie Medical Dba Quality Care Products Llc
    Venlafaxine Hydrochloride Capsule, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Dr. Reddy’s Laboratories Limited
    Venlafaxine Hydrochloride Tablet [Dr. Reddy’s Laboratories Limited]
  • Cadila Healthcare Limited
    Venlafaxine Hydrochloride Capsule, Extended Release [Cadila Healthcare Limited]
  • Physicians Total Care, Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Physicians Total Care, Inc.]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Tablet, Extended Release [Remedyrepack Inc. ]
  • Cardinal Health
    Venlafaxine Hydrochloride Capsule, Extended Release [Cardinal Health]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride (Venlafaxine) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride Tablet [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Venlafaxine Hydrochloride Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Clinical Solutions Wholesale
    Venlafaxine Hydrochloride Capsule, Extended Release [Clinical Solutions Wholesale]
  • Avkare, Inc.
    Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) Capsule, Extended Release [Avkare, Inc.]
  • Cardinal Health
    Venlafaxine Hydrochloride Capsule, Extended Release [Cardinal Health]
  • Clinical Solutions Wholesale
    Venlafaxine Hydrochloride Tablet, Extended Release [Clinical Solutions Wholesale]
  • Lake Erie Medical Dba Quality Care Products Llc
    Venlafaxine Hydrochloride Capsule, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Venlafaxine Hydrochloride Capsule, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Medvantx, Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Medvantx, Inc.]
  • Golden State Medical Supply, Inc
    Venlafaxine Hydrochloride Capsule, Extended Release [Golden State Medical Supply, Inc]
  • Pd-rx Pharmaceuticals, Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Venlafaxine Hydrochloride Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Major Pharmaceuticals
    Venlafaxine Hydrochloride Capsule, Extended Release [Major Pharmaceuticals]
  • American Health Packaging
    Venlafaxine Hydrochloride Capsule, Extended Release [American Health Packaging]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Venlafaxine Hydrochloride Capsule, Extended Release [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • American Health Packaging
    Venlafaxine Hydrochloride Capsule, Extended Release [American Health Packaging]
  • American Health Packaging
    Venlafaxine Hydrochloride Tablet [American Health Packaging]
  • Aidarex Pharmaceuticals Llc
    Venlafaxine Hydrochloride Capsule, Extended Release [Aidarex Pharmaceuticals Llc]
  • Avkare, Inc.
    Venlafaxine Hydrochloride Tablet [Avkare, Inc.]
  • Wockhardt Usa Llc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Wockhardt Usa Llc.]
  • Wockhardt Limited
    Venlafaxine Hydrochloride Capsule, Extended Release [Wockhardt Limited]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride (Venlafaxine) Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride (Venlafaxine) Tablet [Remedyrepack Inc. ]
  • Direct Rx
    Venlafaxine Hydrochloride Tablet [Direct Rx]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride (Venlafaxine) Tablet [Remedyrepack Inc. ]
  • Aphena Pharma Solutions – Tennessee, Llc
    Venlafaxine Hydrochloride Capsule, Extended Release [Aphena Pharma Solutions – Tennessee, Llc]
  • Remedyrepack Inc.
    Venlafaxine Hydrochloride (Venlafaxine) Tablet [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Preferred Pharmaceuticals, Inc.]
  • Aphena Pharma Solutions – Tennessee, Llc
    Venlafaxine Hydrochloride Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Aphena Pharma Solutions – Tennessee, Llc
    Venlafaxine Hydrochloride Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Bryant Ranch Prepack
    Venlafaxine Hydrochloride (Venlafaxine) Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Venlafaxine Hydrochloride Tablet [Bryant Ranch Prepack]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Venlafaxine Hydrochloride Capsule, Extended Release [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Teva Pharmaceuticals Usa Inc
    Venlafaxine Hydrochloride Tablet [Teva Pharmaceuticals Usa Inc]
  • Mylan Pharmaceuticals Inc.
    Venlafaxine Hydrochloride Tablet [Mylan Pharmaceuticals Inc.]
  • Upstate Pharma, Llc
    Venlafaxine Hydrochloride Tablet, Film Coated, Extended Release [Upstate Pharma, Llc]
  • Kremers Urban Pharmaceuticals Inc.
    Venlafaxine Hydrochloride Tablet, Extended Release [Kremers Urban Pharmaceuticals Inc.]
  • Carilion Materials Management
    Venlafaxine Hydrochloride Tablet [Carilion Materials Management]
  • Zydus Pharmaceuticals (Usa) Inc.
    Venlafaxine Hydrochloride Capsule, Extended Release [Zydus Pharmaceuticals (Usa) Inc.]
  • Aurobindo Pharma Limited
    Venlafaxine Hydrochloride Capsule, Extended Release [Aurobindo Pharma Limited]
  • Bryant Ranch Prepack
    Venlafaxine Hydrochloride Capsule, Extended Release [Bryant Ranch Prepack]
  • Teva Pharmaceuticals Usa Inc
    Venlafaxine Hydrochloride Capsule, Extended Release [Teva Pharmaceuticals Usa Inc]
  • Amneal Pharmaceuticals Of New York, Llc
    Venlafaxine Hydrochloride (Venlafaxine) Tablet [Amneal Pharmaceuticals Of New York, Llc]
  • Carilion Materials Management
    Venlafaxine Hydrochloride Capsule, Extended Release [Carilion Materials Management]
  • Torrent Pharmaceuticals Limited
    Venlafaxine Hydrochloride Capsule, Extended Release [Torrent Pharmaceuticals Limited]
  • Greenstone Llc
    Venlafaxine Hydrochloride Capsule, Extended Release [Greenstone Llc]