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Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC Supply Disruption — American Pharmaceutical Ingred

Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC Supply Disruption — American Pharmaceutical Ingred is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC; Manufacturer: Americ

Drug nameBaclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC
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-0476-2018
Initiation date20180209
Quantity affected55500 g
Dosage formDrugs

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