Class II · Moderate risk
UREA 40% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
C-Urea 40% Bladder Instill
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drug: Urea
- Recalling firm
- Colonia Care Pharmacy
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0033-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Urea recalls
See all
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk
Remeven Cream
Crystallization; Complaints that cream appears to have crystallized
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 recalls by Colonia Care Pharmacy
All 2019 recalls
Class II · Moderate risk
C-Verapamil 2.5mg/Ml Inj Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Tacrolimus 0.03% Ophthal Suspension
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Phenol/Cottonseed Oil Inj 5%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Papav/Phentol/Pge1 30mg/2mg/20mcg/Ml
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.