FDA recall D-0247-2015

Product

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01

Reason for recall

Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-04-14

Report date

2014-11-19

Termination date

2016-03-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melrose Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2015