Reported Jan 29, 2014 · Terminated
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC…
KVK-Tech, Inc.
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: KVK-Tech, Inc. · 110 Terry Dr · Newtown, PA · 18940-3427
Is this the product you have?
- HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
- Lot codes and dates
lot #11434exp. Nov-14
- Amount recalled
- 14664 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
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.
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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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