Drug 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
D-1465-2016
Product summary
- Firm
- Exact-Rx Inc
- Event
- Event 74744
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
- Official record key
drug-enforcement:D-1465-2016
Official wording
Reason: Crystallization; complaints received by the manufacturer of crystals forming in product
Code information: Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Crystallization; complaints received by the manufacturer of crystals forming in product