FDA-Drug2019-10-16Class II

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

Unipharma, Llc.
Hazard

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

Sold states
U.S.A. Nationwide
Affected count
456 cartons
Manufactured in
10200 NW 67th St, N/A, Tamarac, FL, United States
Products
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

Official notice

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

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