Phenobarbital Tablets USP recalled over labeling errors

Recall date

April 20, 2017

Source

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

Official notice title

C. O. Truxton recalls Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), R…

Recall number

D-1114-2017

FDA classification

Class II

Brand / firm

C. O. Truxton

Sold / distributed

Nationwide

Why it was recalled

Labeling: Label Mixup; potentially mislabeled

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 Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031