FDA-Drug2019-07-03Class II
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.
Premier Pharmacy Labs Inc
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.
Sold states
Nationwide in the USA
Affected count
13150 vials
Manufactured in
8265 Commercial Way, N/A, Weeki Wachee, FL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1426-2019Don't want to check this manually?
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