D-1465-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 31, 2016
- Initiation Date
- June 2, 2016
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Product Description
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
Reason for Recall
Crystallization; complaints received by the manufacturer of crystals forming in product
Distribution Pattern
Nationwide
Code Information
Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018