PHENOBARBITAL Sodium Injection recalled over sterility concerns

Recall date

March 14, 2022

Source

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

Official notice title

Vitae Enim Vitae Scientific, Inc. recalls PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL…

Recall number

D-0743-2022

FDA classification

Class II

Brand / firm

Vitae Enim Vitae Scientific, Inc.

Sold / distributed

Nationwide in the U.S.A

Why it was recalled

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

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

What was recalled

PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.