Drugplain

Sumatriptan 50 mg/1

Sumatriptan Succinate · TABLET · Asclemed USA, Inc.

9 Recalls on RecordCurrently in Shortage
Plain English

Sumatriptan is a tablet containing sumatriptan succinate at 50 mg/1, taken oral. Manufactured by Asclemed USA, Inc..

Key Facts

Brand Name
Sumatriptan
Generic Name
Sumatriptan Succinate
NDC Code (Product)
76420-498
Manufacturer
Asclemed USA, Inc.
Strength
50 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA078327
Marketing Start
08/17/2009

Recall History

9 Recalls on Record
Class II11/06/2013

GlaxoSmithKline, LLC.

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

TerminatedVoluntary: Firm initiated
Class II12/26/2019

Sun Pharmaceutical Industries, Inc.

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

TerminatedVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

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 II02/09/2018

American Pharmaceutical Ingredients LLC

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

TerminatedVoluntary: Firm initiated
Class II02/09/2018

American Pharmaceutical Ingredients LLC

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

TerminatedVoluntary: Firm initiated
Class II11/06/2013

GlaxoSmithKline, LLC.

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

TerminatedVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class II12/26/2019

Sun Pharmaceutical Industries, Inc.

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective2,753 reports
headache2,083 reports
migraine1,779 reports
nausea1,732 reports
fatigue1,458 reports
dizziness1,160 reports
pain1,152 reports
off label use1,117 reports
product dose omission issue967 reports
vomiting928 reports

Frequently Asked Questions

What is Sumatriptan used for?

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

Is Sumatriptan a controlled substance?

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

What is the generic name for Sumatriptan?

The generic name for Sumatriptan is Sumatriptan Succinate. There are 6 other brand versions of Sumatriptan Succinate.

What is the NDC code for Sumatriptan 50 mg/1?

The NDC (National Drug Code) for Sumatriptan 50 mg/1 is 76420-498, listed by Asclemed USA, Inc..