Drug product
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10
D-0604-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,168 bottles
- Official record key
drug-enforcement:D-0604-2022
Official wording
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Code information: Batch: 1BK0827, Exp 12/31/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations