FDA recall D-0661-2016

Safecor Health, LLC · Class II · drug

Product

Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.

Reason for recall

Defective Container: Confirmed customer complaints of leaking bottles.

Distribution

Key facts

Status: Terminated
Initiation date: 2015-03-02
Report date: 2016-02-17
Termination date: 2016-02-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2016