FDA Recalls HydrOXYzine HCl Tablets Due to Unapproved Ingredient Source
American Health Packaging is recalling HydrOXYzine HCl Tablets because the active pharmaceutical ingredient came from an unapproved source.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, manufactured by KVK-TECH, INC. and distributed by American Health Packaging. The recall involves 14,665 blister packs distributed nationwide.
The reason for the recall is a deviation from Good Manufacturing Practices, specifically that the product contains an active pharmaceutical ingredient from an unapproved source. The affected lots include 120407 (Exp 01/14), 121337 (Exp 03/14), 122054 (Exp 05/14), 122598 (Exp 06/14), and 130125 (Exp 12/14).
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 14,665
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 (9)
- Lot 120407
- Exp 01/14
- Lot 121337 Exp 03/14
- Lot 122054
- Exp 05/14
- Lot 122598
- Exp 06/14
- Lot 130125
- Exp 12/14
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.
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