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FDAJune 18, 2019drug

Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack 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.

What to do

FDA enforcement status: Terminated

Brands named

premier pharmacy labspremierpremier pharmacy

UPCs

869623232393

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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