Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL
Lack of Assurance of Sterility
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Baclofen 5000 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml
Lack of Assurance of Sterility
Class III · Low risk
Triamcinolone Diacetate Injectable Suspension
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
Normosol-M and 5% Dextrose
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Class III · Low risk
Atorvastatin Calcium 80 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 40 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 20 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 10 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Menthocin Patch with Lidocaine-Strong
Marketed without an approved NDA/ANDA
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Class I · High risk
CLINIMIX E 5/15 sulfite-free
Presence of Particulate Matter: identified as dried skin.
Class I · High risk
Metronidazole Injection USP
Presence of Particulate Matter: identified as a cloth fiber.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: identified as cardboard.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Class II · Moderate risk
Nystatin
Labeling: label error on declared strength.
Class II · Moderate risk
Nystatin
Labeling: label error on declared strength.
Class III · Low risk
Tropicamide Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk
Tropicamide Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk
Cyclopentolate Hydrochloride Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class II · Moderate risk
Levofloxacin Tablets USP
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.