Haloperidol Decanoate Injection recalled over sterility concerns

Recall date

April 26, 2021

Source

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

Official notice title

Teva Pharmaceuticals USA recalls Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceutical…

Recall number

D-0378-2021

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Product was distributed nationwide.

Why it was recalled

Lack of Assurance of Sterility

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 Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03