Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
HydrOXYzine HCI Tablets USP 25 mg (Hydroxyzine Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.
Affected NDCs
10702-0011-01
10702-0011-10
10702-0011-50
Compare with the code on your package — it is the most precise check available.
Drug: Hydroxyzine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Hydroxyzine Hydrochloride NDC 10702-0011 |
HYDROXYZINE DIHYDROCHLORIDE 25 mg/1 | Tablet, Film Coated Oral |
KVK-Tech, Inc. | Rx |
- Recalling firm
- KVK-Tech, Inc.
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1031-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydroxyzine recalls
See all
Class II · Moderate risk
HydrOXYzine Pamoate Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
Hydroxyzine Hydrochloride Oral Solution
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II · Moderate risk
HydrOXYzine HYDROCHLORIDE SYRUP
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II · Moderate risk
Hydroxyzine HCl
Lack of Assurance of Sterility
Other recalls by KVK-Tech, Inc.
All 2013 recalls
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
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