C-UREA 40% BLADDER INSTILL recalled over sterility concerns
- Recall date
- July 24, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Colonia Care Pharmacy recalls C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Recall number
- D-0033-2020
- FDA classification
- Class II
- Brand / firm
- Colonia Care Pharmacy
- Sold / distributed
- Patient Specific Prescriptions in NJ
Why it was recalled
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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
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