Meditech Laboratories, Inc recalls Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Medi…

Recall date

March 14, 2016

Source

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

Recall number

D-0805-2016

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 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.