Drug product
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5
D-0879-2022
Product summary
- Firm
- Bestco LLC
- Event
- Event 90124
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2038 bags
- Official record key
drug-enforcement:D-0879-2022
Official wording
Reason: Subpotent drug: Low OOS for menthol content at the three month room temperature.
Code information: Lot #: 100010885, Exp 11/2024
Distribution pattern: CA, ID, PA, OK
Derived failure modes
-
Potency or specification failure
Subpotent