Drug Enforcement D-387-2014

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

Status

Terminated

Classification

Class II

Report Date

January 1, 2014

Termination Date

August 20, 2014

Product Information

Product description
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00
Product quantity
10,469 Systems
Reason for recall
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
GlaxoSmithKline, LLC.
Address
1011 North Arendell Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-387-2014
Event ID
66988
Recall initiation date
November 6, 2013
Center classification date
December 24, 2013
Code info
Lot#: C636293, Exp: 06/15
More code info
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