Drug & medication recalls Moderate risk

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

Recall date
March 14, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0808-2016
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 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

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