Drug product
Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
D-0617-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,632 bottles
- Official record key
drug-enforcement:D-0617-2022
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
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations