D-388-2014 Class II Terminated
FDA drug recall D-388-2014 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: 9,743 cartridges.
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
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-388-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026