Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brompheniramine Maleate Recalled by Cardinal Health Inc. Due to CGMP Deviations: Intermittent exposure to temperature excursion during...

Date: March 15, 2021
Company: Cardinal Health Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cardinal Health Inc. directly.

Affected Products

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054

Quantity: 15 bottles

Why Was This Recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Where Was This Sold?

This product was distributed to 3 states: FL, GA, SC

Affected (3 states)Not affected

About Cardinal Health Inc.

Cardinal Health Inc. has 240 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report