Class III · Low risk
Fyarro (albumin-bound)
Failed Stability Specifications
C-Albumin 5% Ophth Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Drug: Albumin
- Recalling firm
- Colonia Care Pharmacy
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0004-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Albumin recalls
See all
Class II · Moderate risk
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk
C-*Albumin Eye Drop 10% S
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Other recalls by Colonia Care Pharmacy
All 2019 recalls
Class II · Moderate risk
C-Verapamil 2.5mg/Ml Inj Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Urea 40% Bladder Instill
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Tacrolimus 0.03% Ophthal Suspension
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Phenol/Cottonseed Oil Inj 5%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
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