Meditech Laboratories, Inc recalls Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech…

Recall date

March 14, 2016

Source

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

Recall number

D-0802-2016

FDA classification

Class II

Brand / firm

Meditech Laboratories, Inc

Sold / distributed

Nationwide

Why it was recalled

Superpotent Drug: one ingredient was found to be above assay specification.

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

What was recalled

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.