PlainRecalls
FDA Drug Critical Class I Terminated

8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02

Reported: April 10, 2019 Initiated: March 15, 2019 #D-1073-2019

Product Description

8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02

Reason for Recall

Presence of Particulate Matter; glass particulates

Details

Recalling Firm
Pfizer Inc.
Units Affected
283,400 vials
Distribution
United States and Puerto Rico
Location
New York, NY

Frequently Asked Questions

What product was recalled?
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02. Recalled by Pfizer Inc.. Units affected: 283,400 vials.
Why was this product recalled?
Presence of Particulate Matter; glass particulates
Which agency issued this recall?
This recall was issued by the FDA Drug on April 10, 2019. Severity: Critical. Recall number: D-1073-2019.