FDA recall D-0133-2020

Product

DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2019-09-23

Report date

2019-10-16

Termination date

2021-03-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tamarac, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0133-2020