Urea (50% Urea in a Cream Base) recall
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…
Why was Urea (50% Urea in a Cream Base) recalled?
Crystallization; complaints received by the manufacturer of crystals forming in product
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018
- 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…
- Recalling firm
- Exact-Rx Inc
- Quantity
- 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
- Distribution
- Nationwide
- Recall date
- August 31, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)