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Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packa Supply Disruption — American Pharmaceutical Ingre

Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packa Supply Disruption — American Pharmaceutical Ingre is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packa; Manufacturer: Ameri

Drug nameEstradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packa
ManufacturerAmerican Pharmaceutical Ingredients LLC
Recall/Disruption reasonCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in
Risk classificationModerate Risk — Temporary Health Consequence
StatusTerminated
Record typeEnforcement/Recall
Recall numberD-0489-2018
Initiation date20180209
Quantity affected4910 g
Dosage formDrugs

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