June 2016 FDA Recall Drug by Exact-rx Inc
D-1465-2016 - Crystallization; complaints received by the manufacturer of crystals forming in product
This Class III drug recall was voluntarily initiated by Exact-rx Inc on June 2, 2016 for the product Drug. The FDA reported the reason for recall as crystallization; complaints received by the manufacturer of crystals forming in product. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1465-2016
Crystallization; complaints received by the manufacturer of crystals forming in product
06-02-2016
08-31-2016
6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Exact-Rx Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-14-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 's: a) 8160, b) 8160 Exp Date: 9/2018
