FDA recall D-1633-2019

Product

CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207

Reason for recall

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

Distribution

Nationwide in the US.

Key facts

Status

Terminated

Initiation date

2019-07-15

Report date

2019-08-14

Termination date

2020-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tamarac, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1633-2019