Meditech Laboratories, Inc recalls Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditec…

Recall date

March 14, 2016

Source

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

Recall number

D-0806-2016

FDA classification

Class II

Brand / firm

Meditech Laboratories, Inc

Sold / distributed

Nationwide

Why it was recalled

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

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 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.