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Recall Observatory FDA recall evidence

Drug product

Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

D-0316-2024

December 26, 2023

Class I

Product summary

Firm
Haleon US Holdings LLC
Event
Event 93702
Status
Ongoing
Classification
Class I
Quantity
a) 31,632 bottles; b) 336,528 bottles
Official record key
drug-enforcement:D-0316-2024

Official wording

Reason: Microbial Contamination of Non-Sterile Products

Code information: a) Lot#: T10810, Exp 10/31/2025 b) Lot#: T08730, T08731, T08732, T08733, Exp 05/31/2025; T10808, Exp 09/30/2025

Distribution pattern: USA nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination