Pfizer Inc. recalls 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…

Recall date

March 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1073-2019

FDA classification

Class I

Brand / firm

Pfizer Inc.

Sold / distributed

United States and Puerto Rico

Why it was recalled

Presence of Particulate Matter; glass particulates

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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