FDA recall D-1073-2019

Pfizer Inc. · Class I · drug

Product

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

Distribution

United States and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2019-03-15
Report date: 2019-04-10
Termination date: 2021-01-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1073-2019