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.
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 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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