Class III · Low risk Terminated
Fyarro
Reason 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.
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
- Recalling firm
- Colonia Care Pharmacy
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0004-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Albumin recalls
See all
Class II · Moderate risk Terminated
Draximage MAA
Reason Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk Terminated
C-*Albumin Eye Drop 10% S
Reason 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 Terminated
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Volumex
Reason Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
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