Teva Pharmaceuticals USA recalls Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHAR…

Recall date

December 21, 2016

Source

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

Recall number

D-0440-2017

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

United States and Puerto Rico

Why it was recalled

Subpotency: due to a low, 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, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73