Cephalexin for Oral Suspension USP recalled over manufacturing violations

Recall date

January 7, 2019

Source

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

Official notice title

Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, I…

Recall number

D-0380-2019

FDA classification

Class II

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.

Why it was recalled

CGMP Deviation; manufacturing batch record could not be located

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, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02