FDAFDA · Food and drugs·Recall number D-0133-2020
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
Published October 16, 2019 · Recall initiated: September 23, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Unipharma, Llc.
- Distributor
- U.S.A. Nationwide
- Lot
- Lot: 80003 Exp. 01/31/20; 70003 Exp. 10/31/19; 70005 Exp. 11/30/19; 70006 Exp. 11/30/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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