Drug product
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
D-1506-2019
Product summary
- Event
- Event 83190
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2052 bottles
- Official record key
drug-enforcement:D-1506-2019
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