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Recall Observatory FDA recall evidence

Drug product

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.

D-0521-2018

February 09, 2018

Class II

Product summary

Firm
American Pharmaceutical Ingredients LLC
Event
Event 79149
Status
Terminated
Classification
Class II
Quantity
10000 g
Official record key
drug-enforcement:D-0521-2018

Official wording

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

Code information: Lot #: 061615-1, Exp.12/31/2019

Distribution pattern: Nationwide within USA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations