Class II · Moderate risk
C-Urea 40% Bladder Instill
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Remeven Cream
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Crystallization; Complaints that cream appears to have crystallized
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
Drug: Urea
- Recalling firm
- Stratus Pharmaceuticals Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1464-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Urea recalls
See all
Class II · Moderate risk
UREA 40% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class II · Moderate risk
All Germall
Lack of Processing Controls
Class II · Moderate risk
Carbo-O-Philic 40 Gel 40%
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Other failed specification recalls from 2016
All failed specification recalls
Class III · Low risk
Finasteride Tablets
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Class II · Moderate risk
Venlafaxine Hydrochloride extended release capsules
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class II · Moderate risk
Furosemide Tablets USP
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class II · Moderate risk
Lisinopril tablets
Failed tablet/capsule specification: missing break line on the 5mg tablet.
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