Class II
Terminated
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.
- Company
- Premier Pharmacy Labs Inc
- Recall Initiated
- June 18, 2019
- Posted
- July 3, 2019
- Recall Number
- D-1426-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13150 vials
- Firm Location
- Weeki Wachee, FL, United States
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.
Distribution
Nationwide in the USA
Lot / Code Info
All lots remaining within expiry.
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