Recalls / Class II
Class IID-1304-2019
Product
CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
- Affected lot / code info
- Lots: 80026 Exp. 05/31/20; 80027 Exp. 07/31/20
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
- 23712 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-1304-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.