Drug product
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.
D-388-2014
Product summary
- Event
- Event 66988
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,743 cartridges
- Official record key
drug-enforcement:D-388-2014
Official wording
Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Code information: Lot#: C636242, Exp: 06/15
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility