Colonia Care Pharmacy recalls C-ALBUMIN 5% Ophthalmic Solution: Risk of contamination
Colonia Care Pharmacy recalls C-ALBUMIN 5% Ophthalmic Solution bottles due to lack of sterility assurance. This medication is prescription-only and may cause infection if not sterile.
Lower-risk recall
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Contact the company
What happened, in plain English
Colonia Care Pharmacy is recalling prescription C-ALBUMIN 5% Ophthalmic Solution bottles because they cannot be guaranteed to be sterile. Using this product could lead to eye infections if it's not sterile. Read more at govinfonow.com/recall/38215-colonia-care-pharmacy-recalls-c-albumin-5-ophthalmic-solution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38215-colonia-care-pharmacy-recalls-c-albumin-5-ophthalmic-solution-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0004-2020
Cite this page
“Colonia Care Pharmacy recalls C-ALBUMIN 5% Ophthalmic Solution: Risk of contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38215-colonia-care-pharmacy-recalls-c-albumin-5-ophthalmic-solution-risk. Based on FDA recall #D-0004-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0004-2020%22&limit=1).
Why it’s dangerous
The product lacks assurance of sterility, meaning it might not be clean enough to use safely in the eye. This could lead to infections if the solution is contaminated.
Who’s affected
Prescription patients who have purchased the C-ALBUMIN 5% Ophthalmic Solution from Colonia Care Pharmacy. People with eye conditions are most at risk if the solution is not sterile.
How to tell if you have this one
Check for the product name 'C-ALBUMIN 5% Ophthalmic Solution', 10 mL droptainer bottles, and the lot number 071819E with a batch date of 09/01/19. This medication is prescription-only and sold by Colonia Care Pharmacy in Colonia, New Jersey.
- Brand
Colonia Care Pharmacy- Category
Drug
All 32 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Patient Specific Prescriptions in NJ
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0003-2020 | C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: a) 070819A, BUD 08/22/19; b) 071619F, BUD 08/30/19 | 2 droptainer bottles |
| D-0004-2020 | C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 071819E, BUD 09/01/19 | 1 droptainer bottle |
| D-0005-2020 | C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 070119A, BUD 08/15/19; 072219N, BUD 09/05/19 | 12 droptainer bottles |
| D-0006-2020 | C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 071619D, BUD 08/30/19 | 1 droptainer bottles |
| D-0007-2020 | C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 071119C, BUD 08/25/19 | 1 vial |
| D-0008-2020 | C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 070219B, BUD 08/06/19 | 60 nebulizer vials |
| D-0009-2020 | C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 070319G, BUD 08/17/19; 071219P, BUD 08/26/19 | 37 vials |
| D-0010-2020 | C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 072219B, BUD 08/05/19 | 1 droptainer vial |
| D-0011-2020 | C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 070319J, BUD 08/17/19 | 1 vial |
| D-0012-2020 | C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 062619E, BUD 08/10/19 | 30 syringe |
| D-0013-2020 | C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 070919E, BUD 08/23/19 | 15 syringes |
| D-0014-2020 | C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 041119A, BUD 10/08/19; 051019J, BUD 11/6/19; 070519C, BUD 01/01/20 | 18 vials |
| D-0015-2020 | 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; Lot #: 070819B, BUD 08/07/19 | 1 droptainer bottle |
| D-0016-2020 | C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 071819C, BUD 09/01/19 | 6 syringes |
| D-0017-2020 | C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 070919C, BUD 08/23/19 | 15 syringes |
| D-0018-2020 | C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 020719A, BUD 08/06/19; 051619E, BUD 11/12/19 | 191 syringes |
| D-0019-2020 | C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: a) and b) 071119E, BUD 08/25/19 | 6 vials |
| D-0020-2020 | C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 071619J, BUD 08/30/19 | 1 vial |
| D-0021-2020 | C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 072419C, BUD 09/07/19; 071519D, BUD 08/29/19 | 2 vials |
| D-0022-2020 | C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 071519E, BUD 08/29/19 | 1 vial |
| D-0023-2020 | C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 062719E, BUD 08/11/19 | 1 vial |
| D-0024-2020 | C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: a) and b) 070519A, BUD 08/19/19 | 7 vials |
| D-0025-2020 | C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 072219A, BUD 09/05/19 | 1 vial |
| D-0026-2020 | C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 071819H, BUD 09/01/19 | 1 vial |
| D-0027-2020 | C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 062419C, BUD 08/08/19 | 1 vial |
| D-0028-2020 | C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 062419B, BUD 08/08/19 | 1 vial |
| D-0029-2020 | C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 072419B, BUD 09/07/19 | 1 vial |
| D-0030-2020 | C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 070319A, BUD 08/17/19 | 1 vial |
| D-0031-2020 | C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 070319F, BUD 08/17/19 | 1 vial |
| D-0032-2020 | C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 071019B, BUD 08/09/19 | 1 droptainer bottle |
| D-0033-2020 | C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 062719A, BUD 08/11/19 | 7 vials |
| D-0034-2020 | C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067; Lot #: 072319A, BUD 09/06/19 | 1 vial |
What to do — step by step
Check Product Details
Look for the lot number 071819E and batch date 09/01/19 on the bottle label.
Where it went and when
Where it was distributed
Distributed in New Jersey.
FDA distribution: “Patient Specific Prescriptions in NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey.
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0004-2020 (July 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0004-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.