Drug Enforcement D-0316-2024

Microbial Contamination of Non-Sterile Products

Status

Ongoing

Classification

Class I

Report Date

January 31, 2024

Termination Date

Product Information

Product description
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
Product quantity
a) 31,632 bottles; b) 336,528 bottles
Reason for recall
Microbial Contamination of Non-Sterile Products
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
Haleon US Holdings LLC
Address
184 Liberty Corner Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0316-2024
Event ID
93702
Recall initiation date
December 26, 2023
Center classification date
February 7, 2024
Code info
a) Lot#: T10810, Exp 10/31/2025 b) Lot#: T08730, T08731, T08732, T08733, Exp 05/31/2025; T10808, Exp 09/30/2025
More code info