Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
buPROPion Hydrochloride Extended Release Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.
Class II · Moderate risk
Diazepam Injection USP 10mg/2mL
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Class II · Moderate risk
Albuterol Sulfate Syrup
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class II · Moderate risk
Alprazolam Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL
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
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL
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
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL
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
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE
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
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG
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
Ondansetron Injection USP 40 mg/20 mL
CGMP Deviations
Class II · Moderate risk
Eptifibatide Injection 75 mg/100 mL
CGMP Deviations
Class II · Moderate risk
Linezolid Injection 600 mg/300 mL Rx Only
CGMP Deviations
Class II · Moderate risk
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL
CGMP Deviations
Class II · Moderate risk
Oxacillin for Injection
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Class III · Low risk
Methylprednisolone Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Class III · Low risk
Seconal Sodium
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Class III · Low risk
Cyproheptadine Hydrochloride Syrup
Subpotency: product assayed and found OOS for cyproheptadine
Class III · Low risk
Sirolimus Tablets
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk
Ciprofloxacin OPTH 0.3% SOL
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Class II · Moderate risk
Chlorhexidine Gluco. 0.12% Oral Rinse
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Class III · Low risk
CEFTRIAXONE for Injection USP
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.