Drug product
Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10
D-0627-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79,776 botles
- Official record key
drug-enforcement:D-0627-2022
Official wording
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Code information: Batch: 1BK0931, Exp 12/31/2022; 1CK0900, Exp 01/31/2023; 1HK1196, Exp 02/28/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations