8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02
Reported: August 9, 2017 Initiated: June 15, 2017 #D-1047-2017
Product Description
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02
Reason for Recall
Lack of Sterility Assurance
Details
- Recalling Firm
- Hospira a Pfizer Company
- Units Affected
- 91,483,150 50 mL single dose vials
- Distribution
- U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
- Location
- Rocky Mount, NC
Frequently Asked Questions
What product was recalled? ▼
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02. Recalled by Hospira a Pfizer Company. Units affected: 91,483,150 50 mL single dose vials.
Why was this product recalled? ▼
Lack of Sterility Assurance
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 9, 2017. Severity: Moderate. Recall number: D-1047-2017.
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