FDA recall D-1301-2019

Product

DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010

Reason for recall

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Distribution

Nationwide and Venezuela

Key facts

Status

Terminated

Initiation date

2019-05-02

Report date

2019-05-22

Termination date

2020-11-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tamarac, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1301-2019