Class II · Moderate risk Terminated
Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Baclofen 5000 mcg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Triamcinolone Diacetate Injectable Suspension
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended.
Class III · Low risk Terminated
Clonazepam Tablets
Reason Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Class III · Low risk Terminated
Atorvastatin Calcium 80 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 40 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 20 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 10 mg
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Menthocin Patch with Lidocaine-Strong
Reason Marketed without an approved NDA/ANDA
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Class I · High risk Terminated
CLINIMIX E 5/15 sulfite-free
Reason Presence of Particulate Matter: identified as dried skin.
Class I · High risk Terminated
Metronidazole Injection USP
Reason Presence of Particulate Matter: identified as a cloth fiber.
Class I · High risk Terminated
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter: identified as cardboard.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Class II · Moderate risk Terminated
Nystatin
Reason Labeling: label error on declared strength.
Class II · Moderate risk Terminated
Nystatin
Reason Labeling: label error on declared strength.
Class III · Low risk Terminated
Tropicamide Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Tropicamide Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Cyclopentolate Hydrochloride Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.