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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
See all 32 products in this recall →Related recalls
Same manufacturer · Colonia Care Pharmacy
See all →- SevereColonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereColonia Care Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereColonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereColonia Care Pharmacy Recalls Verapamil Injection Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereColonia Care Pharmacy Recalls Sterility-Compromised C-Papav/Phentol/PGE1 Vials
FDA (Drugs) · 2019-10-09
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereColonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns
FDA (Drugs) · 2016-12-28
- HighFDA Recalls Injectable Medication Due to Sterility Assurance Failure
FDA (Drugs) · 2022-09-21
- HighTRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- SevereBladder Instillation Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2014-03-12
- HighFDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure
FDA (Drugs) · 2022-09-21
- HighInjectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21