FDA-Drug2018-02-28Class II

Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.

American Pharmaceutical Ingredients LLC
Hazard

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Sold states
Nationwide within USA.
Affected count
10000 g
Manufactured in
6650 Highland Rd Ste 302, N/A, Waterford, MI, United States
Products
Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0521-2018

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