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Recall Observatory FDA recall evidence

Drug 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

D-0133-2020

September 23, 2019

Class II

Product summary

Firm
Unipharma, Llc.
Event
Event 83881
Status
Terminated
Classification
Class II
Quantity
456 cartons
Official record key
drug-enforcement:D-0133-2020

Official wording

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

Code information: Lot: 80003 Exp. 01/31/20; 70003 Exp. 10/31/19; 70005 Exp. 11/30/19; 70006 Exp. 11/30/19

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations