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.
Reported: July 3, 2019 Initiated: June 18, 2019 #D-1426-2019
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Premier Pharmacy Labs Inc
- Units Affected
- 13150 vials
- Distribution
- Nationwide in the USA
- Location
- Weeki Wachee, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Premier Pharmacy Labs Inc. Units affected: 13150 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 3, 2019. Severity: Moderate. Recall number: D-1426-2019.
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