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
Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What was recalled
Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8089-3
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0522-2018
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 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…
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