Reported Aug 31, 2016 · Terminated
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…
Exact-Rx Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exact-Rx Inc · 105 Baylis Rd · Melville, NY · 11747-3833
Is this the product you have?
- 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
- Lot codes and dates
- Lot #'s: a) 8160
- b) 8160 Exp Date9/2018
- Amount recalled
- 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Where it was sold
- Nationwide
Why it was recalled
Crystallization; complaints received by the manufacturer of crystals forming in product
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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