Colonia Care Pharmacy Recalls C-Urea 40% Bladder Instill Due to Sterility Concerns
Colonia Care Pharmacy is recalling 7 vials of C-Urea 40% Bladder Instill because the product's sterility cannot be guaranteed.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance for a bladder instillation, which carries a significant risk of infection or injury.
Plain-English summary
Colonia Care Pharmacy is recalling 7 vials of C-Urea 40% Bladder Instill, a prescription-only medication. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected product is identified by Lot # 062719A with a beyond-use date of 08/11/19. The recall involves patient-specific prescriptions distributed in New Jersey.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Bladder Instillation
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 062719A
- BUD 08/11/19
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 32 recalled by Colonia Care Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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