Colonia Care Pharmacy Recalls C-Interferon Alfa2B Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Interferon Alfa2B ophthalmic solution 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Colonia Care Pharmacy is recalling C-Interferon Alfa2B 1MILU/ML Ophthalmic Solution, 3 mL droptainer bottles, due to a lack of assurance of sterility. The specific lot number is 070819B with a beyond-use date of 08/07/19.
The recall is limited to patient-specific prescriptions distributed in New Jersey. The source text does not report any illnesses or injuries associated with the use of this product.
Patients who have received this medication should contact their healthcare provider or pharmacy for further instructions on how to proceed.
The recalled product
- Product
- C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, 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 #: 070819B
- BUD 08/07/19
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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