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Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lu...

FDA Recall #D-0380-2019 — Class II — January 7, 2019

Recall #D-0380-2019 Date: January 7, 2019 Classification: Class II Status: Terminated

Product Description

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02

Reason for Recall

CGMP Deviation; manufacturing batch record could not be located

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

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

Product Type

Drugs

Product Quantity

7,215 bottles

Distribution

Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.

Code Information

lot # F602820, Expiry December 2019

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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