Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Comfort Shield
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class I · High risk
Comfort Shield
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Class II · Moderate risk
Amikacin Sulfate Injection
CGMP Deviations
Class II · Moderate risk
Amikacin Sulfate Injection
CGMP Deviations
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 III · Low risk
Desoximetasone Gel USP
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
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