Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
FDA Drug Recalls
86 recalls · Class III, newest first
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of Specification results for Assay
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Class III · Low risk
Methylprednisolone Tablets
Subpotent
Class III · Low risk
23.4% Sodium Chloride Injection
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
Class III · Low risk
Wal-Tussin DM
Incorrect/Undeclared Excipient: Product contains alcohol
Class III · Low risk
NETSPOT (kit for the preparation of Ga 68 dotatate injection)
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class III · Low risk
Atorvstatin Calcium Tablets
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Class III · Low risk
Risedronate Sodium Tablets
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Class III · Low risk
Hydroxocobalamin B12 1mg/mL
Sub Potent
Class III · Low risk
Sb-4
Sub Potent
Class III · Low risk
T-105
Super Potent
Class III · Low risk
Formula F9
Sub Potent
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class III · Low risk
Sapropterin Dihydrochloride Powder for Oral Solution
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class III · Low risk
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%
Subpotent drug
Class III · Low risk
Bortezomib
Failed stability specifications
Class III · Low risk
Azacitidine
Failed stability specifications
Class III · Low risk
Azacitidine
Failed stability specifications
Class III · Low risk
Mucus Relief D
Subpotent drug