Recalls / Class II
Class IID-388-2014
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.
- Affected lot / code info
- Lot#: C636242, Exp: 06/15
Why it was recalled
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Recalling firm
- Firm
- GlaxoSmithKline, LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 North Arendell Ave, N/A, Zebulon, North Carolina 27597-1217
Distribution
- Quantity
- 9,743 cartridges
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-06
- FDA classified
- 2013-12-24
- Posted by FDA
- 2014-01-01
- Terminated
- 2014-08-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-388-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.