Class III · Low risk Terminated
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50…
Reason Failed Stability Specifications
Is Albumin recalled?
9 FDA recalls mention Albumin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Albumin.
Class II · Moderate risk Terminated
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx…
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, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311…
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
C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J…
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB; PACLITAXEL ALBUMIN 160 MG / 100 ml NS IVPB; PACLITAXEL ALBUMIN 145 MG / 100 ml NS IVPB…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By…
Reason Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk Terminated
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By…
Reason Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk Terminated
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Albumin (Bovine) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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