Reported Jan 29, 2014 · Terminated
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940.…
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 50 mg100500and 1000 count bottlesRx only
- Mfd byKVK-TECH, INC, Newtown, PA 18940. 100
- count NDC
10702-012-01500
- count NDC
10702-012-501000
- count NDC10702-012-10
- Lot codes and dates
26 of 26 products
Products covered by this recall # Product as published 1 lot # 10667, Jan-14 2 lot # 10677, exp. Jan-14 3 lot # 10679, exp. Jan-14 4 lot# 10688, exp. May-14 5 lot #10693, exp. Jul-14 6 lot #10854, Jul-14 7 lot # 10942, exp. Sep-14 8 lot #10995, exp.Oct-14 9 lot # 10996, Nov-14 10 lot #11138, exp. Feb-15 11 lot # 11139 Feb-15 12 lot # 11140, exp. Feb-15 13 lot # 11445, exp. Nov-15. NDC: 10702-012-10: lot # 10679, exp. Jan-14 14 lot # 10689, exp. Jun-14 15 lot # 10941, Sep-14 16 lot #10997 17 Nov-14 18 lot #10998, Nov-14 19 lot # 10999, Nov-14 20 lot #11445, exp. Nov-15. NDC: 10702-012-50: lot #10678, exp. Jan-14 - Amount recalled
- 104551 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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