Class II · Moderate risk
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml
Lack of Assurance of Sterility
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
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.
Class I · High risk
Licorice Coughing Liquid
Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
Class III · Low risk
Virt-Nate Prenatal/Postnatal
Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).