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Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc...

FDA Recall #D-1252-2020 — Class II — April 15, 2020

Recall #D-1252-2020 Date: April 15, 2020 Classification: Class II Status: Terminated

Product Description

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

Reason for Recall

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

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

Product Type

Drugs

Product Quantity

4,518 bottles

Distribution

Nationwide with the United States and Puerto Rico.

Code Information

Lot #: F800779, Expiry 4/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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