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.
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
Lot numbers, UPCs & expiration codes
Lot#: C636293, Exp: 06/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-387-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 6, 2013
- FDA report date
- Jan 1, 2014
- Quantity
- 10,469 Systems
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline, LLC.
Original FDA data
Every field from FDA enforcement report D-387-2014, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 66988
- Address
- 1011 North Arendell Ave
- Code information
- Lot#: C636293, Exp: 06/15
- Postal code
- 27597-1217
- Report date
- Jan 1, 2014
- Product type
- Drugs
- Recall number
- D-387-2014
- Classification
- Class II
- Recalling firm
- GlaxoSmithKline, LLC.
- Product quantity
- 10,469 Systems
- Termination date
- Aug 20, 2014
- Reason for recall
- Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 24, 2013