PlainRecalls
FDA Drug Moderate Class II Terminated

CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207

Reported: May 22, 2019 Initiated: May 2, 2019 #D-1304-2019

Product Description

CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), 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.

Details

Recalling Firm
Unipharma, Llc.
Units Affected
23712 cartons
Distribution
Nationwide and Venezuela
Location
Tamarac, FL

Frequently Asked Questions

What product was recalled?
CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207. Recalled by Unipharma, Llc.. Units affected: 23712 cartons.
Why was this product recalled?
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 22, 2019. Severity: Moderate. Recall number: D-1304-2019.