Drug 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
D-1305-2019
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 82754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 816 cartons
- Official record key
drug-enforcement:D-1305-2019
Official wording
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Code information: Lots: a) 90002 Exp. 01/31/21; b) 90008 Exp. 02/28/21
Distribution pattern: Nationwide and Venezuela
Derived failure modes
-
Manufacturing or process control
CGMP Deviations