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
Is Sumatriptan recalled?
9 FDA recalls mention Sumatriptan. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sumatriptan.
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…
Class II · Moderate risk Terminated
Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
Sumatriptan Succinate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use…
Reason Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Class II · Moderate risk Terminated
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of…
Reason Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
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