Recalls / Class II
Class IID-1305-2019
Product
DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098
- Affected lot / code info
- Lots: a) 90002 Exp. 01/31/21; b) 90008 Exp. 02/28/21
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, Tamarac, Florida 33321-6404
Distribution
- Quantity
- 816 cartons
- Distribution pattern
- Nationwide and Venezuela
Timeline
- Recall initiated
- 2019-05-02
- FDA classified
- 2019-05-23
- Posted by FDA
- 2019-05-22
- Terminated
- 2020-11-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1305-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.