Class II · Moderate risk Terminated
Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-522-69
Reason cGMP deviations: Temperature abuse
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
What was recalled
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
- Recalling firm
- GlaxoSmithKline, LLC.
- NDC code
- 0173-0479-00
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-387-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Sumatriptan recalls
See all
Class II · Moderate risk Terminated
Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL single-dose vials, Rx only, Manufacturer: Auromedics…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma…
Reason Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk Terminated
Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count…
Reason Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk Terminated
Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
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