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
Reported: August 31, 2016 Initiated: June 2, 2016 #D-1465-2016
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
Details
- Recalling Firm
- Exact-Rx Inc
- Units Affected
- 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
- Distribution
- Nationwide
- Location
- Melville, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Exact-Rx Inc. Units affected: 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz).
Why was this product recalled? ▼
Crystallization; complaints received by the manufacturer of crystals forming in product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 31, 2016. Severity: Low. Recall number: D-1465-2016.
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