Exact-Rx Recalls Urea Cream Due to Crystallization
Exact-Rx Inc. is recalling specific lots of Urea (50% Urea in a Cream Base) because crystals formed in the product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a physical defect (crystallization) rather than a toxicological hazard.
Plain-English summary
Exact-Rx Inc. is recalling Urea (50% Urea in a Cream Base), a prescription-only topical medication, due to reports of crystallization. The recall covers two specific sizes: 5 oz (142 g) and 9 oz (225 g) tubes. The affected product is manufactured in the U.S.A. for Exact-Rx Inc. in Melville, NY.
The recall is limited to Lot #8160 with an expiration date of 9/2018. The total quantity involved is 6,310 tubes, comprising 3,224 tubes of the 5 oz size and 3,086 tubes of the 9 oz size. The product was distributed nationwide.
The recall was initiated after the manufacturer received complaints regarding crystals forming in the product. This is classified as an FDA Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
- Manufacturer
- Exact-Rx Inc
- Category
- Drug — Topical Medication
- Hazard
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 (2)
- Lot #'s: a) 8160
- b) 8160 Exp Date: 9/2018
Distribution
Distributed nationwide across the United States.
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