Colonia Care Pharmacy Recalls Tacrolimus Ophthalmic Suspension Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific lots of C-Tacrolimus 0.03% ophthalmic suspension because the sterility of the product 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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in ophthalmic products) fall under the Severe category.
Plain-English summary
Colonia Care Pharmacy is recalling C-Tacrolimus 0.03% ophthalmic suspension, 5 mL droptainer bottles, due to a lack of assurance of sterility. The specific product affected is identified by Lot # 071019B with a beyond-use date of 08/09/19. The recall is classified as FDA Class II.
The recall is limited to patient-specific prescriptions distributed in New Jersey. The source text indicates that the sterility of the product cannot be guaranteed, which poses a potential risk to patients using the medication.
Patients who have received this specific lot of medication should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Ophthalmic
- 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 #: 071019B
- BUD 08/09/19
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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