Drug product
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
D-1030-2014
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 67103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14664 bottles
- Official record key
drug-enforcement:D-1030-2014
Official wording
Reason: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Code information: lot #11434, exp. Nov-14
Distribution pattern: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Derived failure modes
-
Manufacturing or process control
Good Manufacturing Practices Deviations