Cefdinir for Oral Suspension USP recalled over manufacturing violations

Recall date

January 2, 2019

Source

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

Official notice title

Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Onl…

Recall number

D-0376-2019

FDA classification

Class II

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Nationwide within the United States

Why it was recalled

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

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

What was recalled

Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA