Cardinal Health Recalls Vaniqa Cream Due to Temperature Excursions
Cardinal Health is recalling 72 tubes of Vaniqa cream distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.
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 involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 72 tubes of Vaniqa (eflornithine hydrochloride) Cream, 13.9%, manufactured for Allegan, Inc. The product is identified by the code 113780 and was distributed in Florida, Georgia, and South Carolina.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Topical Prescription
- Affected units
- 72
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 (1)
- 113780
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. 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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