HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.
Reported: January 29, 2014 Initiated: December 11, 2013 #D-1032-2014
Product Description
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.
Reason for Recall
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Details
- Recalling Firm
- KVK-Tech, Inc.
- Units Affected
- 104551 bottles
- Distribution
- Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
- Location
- Newtown, PA
Frequently Asked Questions
What product was recalled? ▼
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.. Recalled by KVK-Tech, Inc.. Units affected: 104551 bottles.
Why was this product recalled? ▼
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-1032-2014.
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