The Recall Desk
SevereFDA (Drugs)·D-1189-2014·Announced 2014-04-09

FDA Recalls HydrOXYzine HCl Tablets Due to Unapproved Ingredient Source

American Health Packaging is recalling HydrOXYzine HCl 50 mg tablets because the active ingredient came from an unapproved source.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, manufactured by KVK-TECH, INC. and distributed by American Health Packaging. The recall involves 8,570 blister packs distributed nationwide. The affected lots are 120757 (Exp. 02/14), 121104 (Exp. 03/14), 122055 (Exp. 05/14), 123038 (Exp. 07/14), and 125115 (Exp. 11/14).

The reason for the recall is a deviation from Good Manufacturing Practices (GMP). Specifically, the product contains an active pharmaceutical ingredient from an unapproved source. This classification is designated as Class II by the FDA.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative medication options if necessary.

The recalled product

Product
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Manufacturer
American Health Packaging
Category
Drug — Prescription Medication
Hazard
Affected units
8,570

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by American Health Packaging under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · American Health Packaging

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Same hazard · unapproved ingredient source

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