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Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Mo...

FDA Recall #D-0713-2022 — Class II — February 21, 2022

Recall #D-0713-2022 Date: February 21, 2022 Classification: Class II Status: Terminated

Product Description

Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.

Reason for Recall

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Recalling Firm

Morton Grove Pharmaceuticals, Inc. — Morton Grove, IL

Classification

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

Product Type

Drugs

Distribution

Nationwide USA and Puerto Rico

Code Information

Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23

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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