Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 681…

Recall date

November 1, 2019

Source

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

Recall number

D-0306-2020

FDA classification

Class III

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Product was distributed to major distributors/wholesalers throughout the United States.

Why it was recalled

Presence of Foreign substance: identified as a dead ant.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA