Class II · Moderate risk Terminated
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on…
Reason Marketed without an approved NDA/ANDA: Undeclared sibutramine.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Glipizide 2.5 mg Extended-release tablets
Reason Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class II · Moderate risk Terminated
Tazorac
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
Tazorac
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection
Reason Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE 200mg/ml
Reason Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
Class II · Moderate risk Terminated
Amoxicillin for Oral Suspension USP
Reason Superpotent drug: Out of specification test result for assay during stability testing.
Class II · Moderate risk Terminated
Diazepam Injection USP 10mg/2mL
Reason Crystallization: Product contains particulate identified to be crystallized active ingredient.
Class II · Moderate risk Terminated
Albuterol Sulfate Syrup
Reason Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class II · Moderate risk Terminated
Alprazolam Extended-release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL
Reason Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk Terminated
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg --…
Reason Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk Terminated
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL
Reason Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk Terminated
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE
Reason Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk Terminated
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG
Reason Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk Terminated
Ondansetron Injection USP 40 mg/20 mL
Reason CGMP Deviations
Class II · Moderate risk Terminated
Eptifibatide Injection 75 mg/100 mL
Reason CGMP Deviations
Class II · Moderate risk Terminated
Linezolid Injection 600 mg/300 mL Rx Only
Reason CGMP Deviations
Class II · Moderate risk Terminated
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL
Reason CGMP Deviations
Class II · Moderate risk Terminated
Oxacillin for Injection
Reason Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Class II · Moderate risk Terminated
Chlorhexidine Gluco. 0.12% Oral Rinse
Reason Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Class II · Moderate risk Terminated
Nitrofurantoin Oral Suspension
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Itraconazole 0.2%/Mupirocin 0.2%/Triamcinolone 0.03% Nasal Spray
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Clotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic Solution
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.