Drug product
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
D-0331-2024
Product summary
- Firm
- Bestco LLC
- Event
- Event 93869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 cases/6 pack each
- Official record key
drug-enforcement:D-0331-2024
Official wording
Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Code information: 100042290, Exp 12/31/2026
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
particulates
-
Manufacturing or process control
CGMP Deviations