FDA recall D-1300-2019

Product

CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156

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-1300-2019