Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-...
FDA Recall #D-388-2014 — Class II — November 6, 2013
Product Description
Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07.
Reason for Recall
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Recalling Firm
GlaxoSmithKline, LLC. — Zebulon, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9,743 cartridges
Distribution
Nationwide
Code Information
Lot#: C636242, Exp: 06/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated