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FDAFebruary 9, 2018drug

Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

american pharmaceutical ingredientsamericanamerican pharmaceutical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 — Recall Details · AllClear