Class III · Low risk Ongoing
hydrOXYzine Hydrochloride Oral Solution
Reason Presence of foreign substance
HydrOXYzine HCI Tablets USP 25 mg
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.
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.
- Recalling firm
- KVK-Tech, Inc.
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1031-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Hydroxyzine recalls
See all
Class II · Moderate risk Terminated
HydrOXYzine Pamoate Capsules
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride Oral Solution
Reason Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II · Moderate risk Terminated
HydrOXYzine HYDROCHLORIDE SYRUP
Reason CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II · Moderate risk Terminated
Hydroxyzine HCl
Reason Lack of Assurance of Sterility
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