Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HydrOXYzine HCI Tablets USP 10 mg Recalled by KVK-Tech, Inc. Due to Good Manufacturing Practices Deviations: The product has an...

Date: December 11, 2013
Company: KVK-Tech, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact KVK-Tech, Inc. directly.

Affected Products

HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.

Quantity: 14664 bottles

Why Was This Recalled?

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About KVK-Tech, Inc.

KVK-Tech, Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report