Colonia Care Pharmacy Recalls C-Albumin 5% Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Albumin 5% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed via patient-specific prescriptions in New Jersey.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure for an ophthalmic product, align with a Severe rating (Score 4).
Plain-English summary
Colonia Care Pharmacy is recalling C-Albumin 5% Ophthalmic Solution, 10 mL droptainer bottles, prescription only. 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 # 071819E with a beyond-use date of 09/01/19. The product was distributed through patient-specific prescriptions in New Jersey.
Patients who have received this product should contact their healthcare provider or pharmacist for further instructions on how to proceed.
The recalled product
- Product
- C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 1
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 #: 071819E
- BUD 09/01/19
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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