Drug product
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
D-0217-2024
Product summary
- Event
- Event 93708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,160 bottles
- Official record key
drug-enforcement:D-0217-2024
Official wording
Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Code information: Lot # SE23035, Exp 05/31/2026
Distribution pattern: MI, PA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
microbial contamination