Reported Apr 9, 2014 · Terminated

HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC…

American Health Packaging

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: American Health Packaging · 2550 John Glenn Ave · Columbus, OH · 43217-1188

Is this the product you have?

    • HydrOXYzine HCl Tablets
    • USP 25 mg
    • 100 Tablet Blister
  • Rx only Mfd byKVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Lot codes and dates
    • Lot 120407
    • Exp 01/14
    • Lot 121337 Exp 03/14
    • Lot 122054
    • Exp 05/14
    • Lot 122598
    • Exp 06/14
    • Lot 130125
    • Exp 12/14
Amount recalled
14,665 blister packs

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 1, 2015 · Data as of Sep 19, 6:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.