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Premier Pharmacy Labs Inc Recall: Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL

Premier Pharmacy Labs Inc Recall: Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Premier Pharmacy Labs Inc; Product: Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Ph

Recalling firmPremier Pharmacy Labs Inc
ProductDroperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5.
Reason for recallLack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionNationwide in the USA
Recall initiated20190618
Recall numberD-1415-2019
Categorydrug
StateFL
CountryUnited States

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