Drug product
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
D-0332-2024
Product summary
- Firm
- Bestco LLC
- Event
- Event 93869
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1597 cases/ 12 pack each b) 73 cases/4 pack each
- Official record key
drug-enforcement:D-0332-2024
Official wording
Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Code information: a) 100041954, Exp 12/31/2026; b) 100042048, 100042060, 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