Drug product
Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30
D-0618-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41,472 bottles
- Official record key
drug-enforcement:D-0618-2022
Official wording
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Code information: Batch: 1BK0826, Exp 12/31/2022; 1FK1164, Exp 01/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations