FDA recall D-0277-2019

Product

children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.

Reason for recall

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-10-19

Report date

2018-11-21

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0277-2019