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
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
CGMP Deviations