Teva North America recalls Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limite…

Recall date

June 24, 2016

Source

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

Recall number

D-1470-2016

FDA classification

Class II

Brand / firm

Teva North America

Sold / distributed

Nationwide

Why it was recalled

Superpotent drug: Out of specification test result for assay during stability testing.

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

What was recalled

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76