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Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactur Supply Disruption — Zydus Pharmaceuticals USA Inc

Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactur Supply Disruption — Zydus Pharmaceuticals USA Inc is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactur; Manufacturer: Zydus

Drug namePramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactur
ManufacturerZydus Pharmaceuticals USA Inc
Recall/Disruption reasonCGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Risk classificationModerate Risk — Temporary Health Consequence
StatusTerminated
Record typeEnforcement/Recall
Recall numberD-1446-2019
Initiation date20190506
Quantity affected168,330 90-count bottles
Dosage formDrugs

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