Drug product
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
D-0629-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bottles
- Official record key
drug-enforcement:D-0629-2022
Official wording
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Code information: Batch: 1BK0716, Exp 12/31/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations