Papaverine/Phentolamine/Atropine/PGE-1 Injectable recalled over sterility concerns

Recall date

June 15, 2015

Source

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

Official notice title

Liberty Drug & Surgical recalls Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Co…

Recall number

D-1400-2015

FDA classification

Class II

Brand / firm

Liberty Drug & Surgical

Sold / distributed

Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

Why it was recalled

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

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

What was recalled

Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.