West-Ward Pharmaceuticals Corp. recalls Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hi…

Recall date

August 18, 2016

Source

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

Recall number

D-1515-2016

FDA classification

Class III

Brand / firm

West-Ward Pharmaceuticals Corp.

Sold / distributed

Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

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

What was recalled

Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,