Drug product
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
D-1498-2019
Product summary
- Event
- Event 83190
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 bottles
- Official record key
drug-enforcement:D-1498-2019
Official wording
Reason: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Code information: All lots remaining within expiry.
Distribution pattern: Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations