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Recall Observatory FDA recall evidence

Drug product

Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.

D-0475-2018

February 09, 2018

Class II

Product summary

Firm
American Pharmaceutical Ingredients LLC
Event
Event 79149
Status
Terminated
Classification
Class II
Quantity
684 g
Official record key
drug-enforcement:D-0475-2018

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 #: a) 011116-1, Exp. 07/31/2020; b) 011116-1, 011116-2, Exp. 07/31/2020; c) 011116-1, Exp. 07/31/2020

Distribution pattern: Nationwide within USA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations