Cephalexin for Oral Suspension recalled over manufacturing violations

Recall date

August 24, 2020

Source

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

Official notice title

Teva Pharmaceuticals USA recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle w…

Recall number

D-0013-2021

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide in the U.S. and Puerto Rico.

Why it was recalled

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

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

What was recalled

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.