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Recall Observatory FDA recall evidence

Drug product

Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

D-0317-2024

December 26, 2023

Class I

Product summary

Firm
Haleon US Holdings LLC
Event
Event 93702
Status
Ongoing
Classification
Class I
Quantity
21,900 bottles
Official record key
drug-enforcement:D-0317-2024

Official wording

Reason: Microbial Contamination of Non-Sterile Products

Code information: Lot#: T08740, T08742, Exp 06/30/2026

Distribution pattern: USA nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination