Drug product
No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-388-10
D-0615-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 64,512 bottles
- Official record key
drug-enforcement:D-0615-2022
Official wording
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Code information: Batch: 1FK1164, Exp 01/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations