Reported Apr 9, 2014 · Terminated
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC…
American Health Packaging
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: American Health Packaging · 2550 John Glenn Ave · Columbus, OH · 43217-1188
Is this the product you have?
HydrOXYzine HCl TabletsUSP 50 mg100 Tablet Blister
- Rx only Mfd byKVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
- Lot codes and dates
Lot 120757Exp. 02/14Lot 121104Exp 03/14Lot 122055Exp 05/14Lot 123038Exp 07/14Lot 125115Exp 11/14
- Amount recalled
- 8,570 blister packs
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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