Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Phar...

FDA Recall #D-0305-2020 — Class III — November 1, 2019

Recall #D-0305-2020 Date: November 1, 2019 Classification: Class III Status: Terminated

Product Description

Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10

Reason for Recall

Presence of Foreign substance: identified as a dead ant.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

30,516 bottles

Distribution

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

Code Information

Lot #: F802345, F802346, F802347, Exp 11/20

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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