FDA recall D-0034-2025

Product

Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018

Reason for recall

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Distribution

Product was distributed to two accounts that may have distributed the product further to the Retail Level.

Key facts

Status

Ongoing

Initiation date

2024-09-25

Report date

2024-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincoln, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2025