Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot: 80003 Exp. 01/31/20; 70003 Exp. 10/31/19; 70005 Exp. 11/30/19; 70006 Exp. 11/30/19
Why it was recalled
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Recalling firm
- Firm
- Unipharma, Llc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10200 NW 67th St, N/A, Tamarac, Florida 33321-6404
Distribution
- Quantity
- 456 cartons
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-09-23
- FDA classified
- 2019-10-09
- Posted by FDA
- 2019-10-16
- Terminated
- 2021-03-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0133-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.