Drug product
Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.
D-0537-2023
Product summary
- Firm
- Pharma Nobis LLC
- Event
- Event 92080
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 69,615 bottles
- Official record key
drug-enforcement:D-0537-2023
Official wording
Reason: CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Code information: Lots: A70293, A70294, A70295, Exp. 12/2023; A70746, A70747, A70748, A70749, Exp. 01/2024; A73051, A73052, Exp. 05/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
subpotent