FDA recall D-0418-2015

Product

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05

Reason for recall

Defective Container: There were customer complaints of cracked and leaking glass vials.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-08-20

Report date

2015-09-23

Termination date

2017-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0418-2015