US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 24, 2019 (7 years ago)

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.

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

Recalling firm
Colonia Care Pharmacy
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0033-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Washington Homeopathic Products, Inc. D-0858-2021
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Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.

Washington Homeopathic Products, Inc. D-0505-2020