D-388-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2014
- Initiation Date
- November 6, 2013
- Termination Date
- August 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,743 cartridges
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.
Distribution Pattern
Nationwide
Code Information
Lot#: C636242, Exp: 06/15