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Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd.,...

FDA Recall #D-0229-2022 — Class II — November 3, 2021

Recall #D-0229-2022 Date: November 3, 2021 Classification: Class II Status: Terminated

Product Description

Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50

Reason for Recall

Failed Impurities/Degradation Specifications

Recalling Firm

Ascend Laboratories LLC — Parsippany, NJ

Classification

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

Product Type

Drugs

Product Quantity

4104 bottles

Distribution

Nationwide

Code Information

Lot 20140282, exp Dec 2021

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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