Class II · Moderate risk
Eye Irrigating Solution
Lack of assurance of sterility
FDA Drug Recalls
6,161 recalls · Class II, newest first
Class II · Moderate risk
Phenylephrine HCI Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Class II · Moderate risk
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Class II · Moderate risk
C-Pav/Phentol/Atrop/Pge1
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II · Moderate risk
C-Pav/Phentol/Pge1
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II · Moderate risk
DMSO 50% with Lidocaine 0.5%
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility
Class II · Moderate risk
C-PAP/PHEN/PROST/Atrop 150/7.5
Lack of Assurance of Sterility
Class II · Moderate risk
Olopatadine 0.8% Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
C-Pap/Phen/Prost/Atrop 150/5/5
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyzine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Autologous Serum Tears
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 15mg/ml Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin HCl 1 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Brilliant Blue G
Lack of Assurance of Sterility
Class II · Moderate risk
Trypan Blue 0.3%
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg
Lack of Assurance of Sterility
Class II · Moderate risk
Papaverine 150 mg / Phentolamine 5 mg vials
Lack of Assurance of Sterility
Class II · Moderate risk
Moxi/Dex/Ketorolac 0.5%/0.1%/0.4%
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.5% + Dexamethazone 0.1%
Lack of Assurance of Sterility