Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kvk-Tech, Inc. | Newtown, PA, United States | Makes it | Serious problems, FDA actionMar 14, 2025 · 13 inspections, 3 with FDA action |
Recalls
- Dec 11, 2013 · Class II · KVK-Tech, Inc.
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Lots: lot #11434, exp. Nov-14 - Dec 11, 2013 · Class II · KVK-Tech, Inc.
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Lots: NDC: 10702-011-01: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot # 10789, exp.May-14; lot #10790, exp. Jun-14; lot # 10791, exp. Jun-14: lot # 10792, exp. Aug-14; lot #10983, exp. Sep-14; lot #10984, exp.Sep-14; lot #10986, exp. Oct-14; lot # 11034, exp. Nov-14; lot #11035, exp. Dec-14; l… - Dec 11, 2013 · Class II · KVK-Tech, Inc.
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Lots: NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; lot# 10688, exp. May-14; lot #10693, exp. Jul-14; lot #10854, Jul-14; lot # 10942, exp. Sep-14; lot #10995, exp.Oct-14; lot # 10996, Nov-14; lot #11138, exp. Feb-15; lot # 11139 Feb-15; lot # 11140, exp. Feb…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydroxyzine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA040786
- On the market since
- Jul 24, 2012
- Package NDCs
10702-012-0110702-012-1010702-012-50- Official label
- DailyMed (National Library of Medicine), updated Jan 4, 2023
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