Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin P...

FDA Recall #D-0390-2021 — Class II — April 29, 2021

Recall #D-0390-2021 Date: April 29, 2021 Classification: Class II Status: Terminated

Product Description

Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01

Reason for Recall

Subpotent Drug

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,138 bottles

Distribution

Nationwide within the United States

Code Information

Lot #: F900787, Exp. Date 4/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated