The Recall Desk
ModerateFDA (Drugs)·D-0474-2021·Announced 2021-06-02

Cardinal Health Recalls Brompheniramine and Pseudoephedrine Syrup Due to Temperature Excursions

Cardinal Health Inc. is recalling 73 cartons of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation (temperature excursion) without reported adverse health consequences, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Cardinal Health Inc. is recalling 73 cartons of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup (10-30-2mg/5ml, 473ml). The product is identified by NDC 71930-026-43 and code 13120103A. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. The source text does not specify the exact dates of distribution or the specific retail locations where the product was sold.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,)
Brand
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Syrup
Hazard
Affected units
73

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)

  • 13120103A

UPCs (2)

  • 0371930026188
  • 0371930026430

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 →

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