FDA recall D-316-2013

Product

Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73

Reason for recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-02-26

Report date

2013-05-15

Termination date

2014-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-316-2013