Reported Jan 29, 2014 · Terminated
HydrOXYzine HCI Tablets USP 25 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 25 mg100500and 1000 count bottlesRx only
- Mfd byKVK-TECH, INC, Newtown, PA 18940. 100
- count NDC
10702-011-01500
- count NDC
10702-011-501000
- count NDC10702-011-10
- Lot codes and dates
31 of 31 products
Products covered by this recall # Product as published 1 10702-011-01: lot #10666, exp. Feb-14 2 lot #10733, exp. May-14 3 lot # 10789, exp.May-14 4 lot #10790, exp. Jun-14 5 lot # 10791, exp. Jun-14: lot # 10792, exp. Aug-14 6 lot #10983, exp. Sep-14 7 lot #10984, exp.Sep-14 8 lot #10986, exp. Oct-14 9 lot # 11034, exp. Nov-14 10 lot #11035, exp. Dec-14 11 lot # 11036, exp. Dec-14 12 lot #11435, exp. Nov-15. NDC: 10702-011-10: lot #10666, exp. Feb-14 13 lot #10733, exp. May-14 14 lot #10789, exp. May-14 15 lot #10790, exp. Jun-14 16 lot #10791, exp. Jun-14 17 lot #10792, exp. Aug-14 18 lot # 10983, exp. Sep-14 19 lot #10985, exp. Oct-14 20 lot #11034, exp. Nov-14 - Amount recalled
- 249,096 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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