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.
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, 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.
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 · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereNatures Pharmacy Recalls Tacrolimus Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2014-03-12
- SevereTacrolimus 0.02% Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-03-12
- HighTacrolimus Ophthalmic Solutions Recalled for Sterility Assurance Issues
FDA (Drugs) · 2023-02-01
- SevereColonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns
FDA (Drugs) · 2016-12-28
- SevereTacrolimus eye drops recalled due to sterility concerns
FDA (Drugs) · 2013-07-17
- SevereMedical Center Pharmacy Recalls C-Albumin Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2020-04-08