Drug Enforcement D-0317-2024

Microbial Contamination of Non-Sterile Products

Status

Ongoing

Classification

Class I

Report Date

January 31, 2024

Termination Date

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Product Information

Product description
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
Product quantity
21,900 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-0317-2024
Event ID
93702
Recall initiation date
December 26, 2023
Center classification date
February 7, 2024
Code info
Lot#: T08740, T08742, Exp 06/30/2026
More code info
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