FDA recall D-0818-2016

Product

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

Reason for recall

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-04-07

Report date

2016-04-20

Termination date

2016-11-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0818-2016