Class II · Moderate risk
calcium elemental
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
FDA Drug Recalls
5,405 recalls, newest first
Class II · Moderate risk
Bupivacaine
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Lack of Assurance of Sterility: Failed preservative effectiveness test
Class II · Moderate risk
Baclofen
Lack of assurance of sterility
Class II · Moderate risk
IT Custom Compound
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 1 mg/ml in 40 ml NS syringe
Lack of Assurance of Sterility
Class II · Moderate risk
3-in-1 TPN formula daily+overfill Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride/MVI injection 2000 mL Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride injection bag
Lack of Assurance of Sterility
Class II · Moderate risk
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Cefepime 1 g/NS 100 mL Minibag Plus
Lack of Assurance of Sterility
Class II · Moderate risk
Tobramycin 620 mg/NS 100 mL Accuflo
Lack of Assurance of Sterility
Class II · Moderate risk
Remicade (Infliximab)
Lack of Assurance of Sterility
Class II · Moderate risk
Nafcillin 12 gm in NS 500 mL bag
Lack of Assurance of Sterility
Class II · Moderate risk
Clindamycin injection
Lack of Assurance of Sterility
Class II · Moderate risk
Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Teflaro 600 mg in 100 mL NS Minibag Plus
Lack of Assurance of Sterility
Class II · Moderate risk
IVIG Gammagard injection bag
Lack of Assurance of Sterility
Class II · Moderate risk
Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Insulin Regular
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Ascorbate
Lack of Assurance of Sterility
Class II · Moderate risk
Folic Acid 1 mg/0.2 mL syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Thiamine 100 mg
Lack of Assurance of Sterility
Class II · Moderate risk
Phytonadione
Lack of Assurance of Sterility
Class II · Moderate risk
IVIG Gamunex 40 gm
Lack of Assurance of Sterility