The Recall Desk
ModerateFDA (Drugs)·D-0387-2024·Announced 2024-03-20

FDA Recalls Broncochem Cold & Tea Nationwide for Stability Failures

Global Corporation is recalling Broncochem Cold & Tea nationwide due to stability testing failures in the active ingredients. No illnesses or injuries have been reported.

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: FDA Class II recall with no reported illnesses or injuries. Stability testing failures for active ingredients constitute a quality defect classified as precautionary.

Plain-English summary

Global Corporation is recalling 2,345 boxes of Broncochem Cold & Tea containing acetaminophen, phenylephrine hydrochloride, and chlorpheniramine maleate. The nationwide recall affects lots 123255 and 123256 (expiration 11/2024) and lot 123637 (expiration 03/2025).

Stability testing failures were identified for phenylephrine hydrochloride and/or chlorpheniramine maleate in the finished drug product. These failures indicate that the active ingredients may not remain stable throughout their shelf life.

No illnesses or injuries related to this product have been reported. Global Corporation recommends that consumers who have purchased affected lots should stop using the product and consult their healthcare provider with any questions about their use of this medication.

The recalled product

Product
BRONCOCHEM (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE)
Brand
BRONCOCHEM
Manufacturer
Global Corporation
Hazard
  • stability-failure

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 (5)

  • Lot #: 123255
  • 123256
  • Exp. Date 11/2024
  • 123637
  • Exp. Date 03/2025

UPCs (1)

  • 0805418097532

Distribution

Distributed nationwide across the United States.