D-387-2014 Class II Terminated
FDA drug recall D-387-2014 was initiated by GlaxoSmithKline, LLC. on Nov 6, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. The recall status is terminated (terminated Aug 20, 2014). Affected quantity: 10,469 Systems.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 1, 2014
- Initiation Date
- Nov 6, 2013
- Termination Date
- Aug 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,469 Systems
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
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#: C636293, Exp: 06/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-387-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026