Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications: Out-of-specification results in retained sample.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Zinc Acetate
Reason Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Class II · Moderate risk Terminated
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension
Reason 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 Terminated
2% Chlorhexidine Gluconate* Cloth
Reason CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class II · Moderate risk Terminated
Comfort Shield
Reason CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class II · Moderate risk Terminated
Amikacin Sulfate Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
Amikacin Sulfate Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
C-Pav/Phentol/Atrop/Pge1
Reason Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II · Moderate risk Terminated
C-Pav/Phentol/Pge1
Reason Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II · Moderate risk Terminated
DMSO 50% with Lidocaine 0.5%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hyaluronidase
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
C-PAP/PHEN/PROST/Atrop 150/7.5
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Olopatadine 0.8% Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
C-Pap/Phen/Prost/Atrop 150/5/5
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyzine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pre-Op Pledget Soln + Tetracaine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pre-Op Pledget Soln
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Autologous Serum Tears
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin 5
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 15mg/ml Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin HCl 1 mg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Brilliant Blue G
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trypan Blue 0.3%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Papaverine 150 mg / Phentolamine 5 mg vials
Reason Lack of Assurance of Sterility