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Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured fo...

FDA Recall #D-1406-2020 — Class II — July 2, 2020

Recall #D-1406-2020 Date: July 2, 2020 Classification: Class II Status: Terminated

Product Description

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20

Reason for Recall

Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

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

Product Type

Drugs

Product Quantity

35,928 bottles

Distribution

U.S.A. Nationwide

Code Information

Lot # F802189, Exp 10/2020, F900240, Exp 1/2021

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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