drugs Class II Updated 2018-02-28

American Pharmaceutical Ingredients LLC recalls Estradiol Hemihydrate USP (Micronized) (Soy) for prescriptio

Recalled Product

Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: #:a) 083017-1, Exp. 7/22/2022; b) 083017-1, Exp. 7/22/2022; c) 083017-1, Exp. 7/22/2022.
View official government recall

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