The Recall Desk
ModerateFDA (Drugs)·D-0596-2021·Announced 2021-06-02

Cardinal Health Recalls Cough Syrup Due to Temperature Excursions

Cardinal Health Inc. is recalling 15 bottles of a cough syrup due to intermittent temperature excursions during storage.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 15 bottles of Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup. The product is a 1-pint (473 mL) bulk container labeled 'Not for Household Use' and 'Rx Only.' The recall is associated with the code UV1092.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.

Consumers and healthcare providers should check their inventory for this specific product and code. If found, the product should be quarantined and not used. For more information, contact the recalling firm or the FDA.

The recalled product

Product
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
Manufacturer
Cardinal Health Inc.
Category
Drug — Oral Syrup
Hazard
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UV1092

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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