FDAFDA · Food and drugs·Recall number D-0522-2018
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
Published February 28, 2018 · Recall initiated: February 9, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Distributor
- Nationwide within USA.
- Lot
- Lot #: a) SUT1213030SP-11192014, Exp. 11/30/2018; b) SUT1213030SP-11192014, exp. 11/30/2018; c) SUT1213030SP-7222015, Exp.11/30/2018.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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