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
FDA recall notice · announced October 16, 2019 · Unipharma
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: U.S.A. Nationwide
Lot/code information: Lot: 80003 Exp. 01/31/20; 70003 Exp. 10/31/19; 70005 Exp. 11/30/19; 70006 Exp. 11/30/19
Quantity: 456 cartons
Status: Terminated
Products in this recall event:
- DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 3332 (D-0132-2020)
- 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: UN (D-0133-2020)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.