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Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 5 Supply Disruption — American Pharmaceutical Ingre

Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 5 Supply Disruption — American Pharmaceutical Ingre is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 5; Manufacturer: Ameri

Drug nameBiotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 5
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-0536-2018
Initiation date20180209
Quantity affected7255 g
Dosage formDrugs

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