Formula 9 Injection recalled over sterility concerns

Recall date

March 14, 2016

Source

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

Official notice title

Meditech Laboratories, Inc recalls Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Medi…

Recall number

D-0804-2016

FDA classification

Class II

Brand / firm

Meditech Laboratories, Inc

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility: incomplete or missing data regarding production.

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 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.