Safecor Health, LLC recalls Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceutical…

Recall date

March 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0661-2016

FDA classification

Class II

Brand / firm

Safecor Health, LLC

Sold / distributed

NJ

Why it was recalled

Defective Container: Confirmed customer complaints of leaking bottles.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.