West-Ward Pharmaceuticals Corp. recalls Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmace…

Recall date

November 4, 2016

Source

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

Recall number

D-0147-2017

FDA classification

Class III

Brand / firm

West-Ward Pharmaceuticals Corp.

Sold / distributed

Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01