American Health Packaging HydrOXYzine HCl Tablets Recall

Why it was recalled

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Product description

HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01

Lot numbers, UPCs & expiration codes

Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1189-2014
Classification: Class II
Status: Terminated
Recall initiated: Jan 31, 2014
FDA report date: Apr 9, 2014
Quantity: 8,570 blister packs
Recall type: Voluntary: Firm initiated
Recalling firm: American Health Packaging

Original FDA data

Every field from FDA enforcement report D-1189-2014, exactly as published.

Show all FDA fields

City: Columbus
State: OH
Status: Terminated
Country: United States
Event ID: 67881
Address: 2550 John Glenn Ave
Address (line 2): Suite A
Code information: Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14
Postal code: 43217-1188
Report date: Apr 9, 2014
Product type: Drugs
Recall number: D-1189-2014
Classification: Class II
Recalling firm: American Health Packaging
Product quantity: 8,570 blister packs
Termination date: Apr 1, 2015
Reason for recall: Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Voluntary / mandated: Voluntary: Firm initiated
Product description: HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Distribution pattern: Nationwide
Recall initiation date: Jan 31, 2014
Initial firm notification: Letter
Center classification date: Apr 3, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1189-2014, published Apr 9, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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