| Date |
Drug/Device |
Alert |
| 5.15.13 |
In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area |
DRUG ALERT |
| 5.1.13 |
Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage |
DEVICE WARNING |
| 5.1.13 |
Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall - Particulate Matter |
DRUG WARNING |
| 4.24.13 |
CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall – Communication Error When Attached to EtCO2 or SpO2 Modules |
DEVICE WARNING |
| 4.24.13 |
All Sterile Compounded Products by Nora Apothecary and Alternative Therapies: Recall - Lack of Sterility Assurance |
DRUG ALERT |
| 4.24.13 |
Balanced Solutions All Sterile Compounded Products: Recall - Lack of Sterility Assurance |
DRUG ALERT |
| 4.22.13 |
Sterile Products Compounded, Repackaged, and Distributed by ApothéCure: Recall - Sterility Assurance Concerns |
DRUG ALERT |
| 4.19.13 |
Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns |
DRUG ALERT |
| 4.3.13 |
Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates |
DRUG WARNING |
| 4.1.13 |
Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed |
DRUG CAUTIONARY NOTICE |
| 3.20.13 |
Lidocaine Hydrochloride and 5% Dextrose Injection: Labeling Changes |
DRUG ALERT |
| 3.20.13 |
Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5 percent In Water, 50ml For Injection Due To Mold Contamination |
DRUG CAUTIONARY NOTICE |
| 3.20.13 |
Qualaquin (quinine sulfate) capsules: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 2.28.13 |
Lumenis VersaCut Tissue Morcellator: Class 1 Recall -Labeling Correction - Potential for Air Embolisms to Occur If Tubing Is Hooked Up Backwards |
DEVICE CAUTIONARY NOTICE |
| 2.19.13 |
Reumofan Plus: Recall - Undeclared Drug Ingredient |
DRUG WARNING |
| 1.02.13 |
Zimmer Spine - PEEK Ardis Inserter: Class I Recall – Risk of Implant Breakage |
DEVICE ALERT |
| 12.27.12 |
Medtronic Drug Infusion Pumps: Recall - Intermittent or Permanent Pump Motor Stall |
DEVICE WARNING |
| 12.18.12 |
Title: Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin: Class I Recall - Potential for Packaging Breach
ALERT |
DRUG ALERT |
| 12.17.12 |
Drug Safety Communication - Important change to heparin container labels to clearly state the total drug strength |
DRUG WARNING |
| 12.12.12 |
Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets updated 12/27/12 |
DRUG WARNING |
| 11.7.12 |
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication Update - Safety Review of Post-Market Reports of Serious Bleeding Events |
DRUG CAUTIONARY NOTICE |
| 10.5.12 |
Multi‐State Investigation of Meningitis Among Patients Who Received Epidural Steroid Injections updated 11/20/12 |
DRUG ALERT |
| 9.25.12 |
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Watson Laboratories): Recall - Potential for Oversized and Superpotent Tablets |
DRUG WARNING |
| 9.18.12 |
Over-The-Counter Topical Muscle and Joint Pain Relievers: Drug Safety Communication - Rare Cases of Serious Burns |
DRUG CAUTIONARY NOTICE |
| 9.12.12 |
Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets |
DRUG WARNING |
| 9.11.12 |
I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall - Risk of Continuous Infusion at a Rate Greater Than Expected |
DEVICE WARNING |
| 8.29.12 |
Covidien Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits that Contain DGPHP RFA High-Power Single Use Grounding Pads |
DEVICE WARNING |
| 8.28.12 |
CareFusion Alaris Pump Module Model 8100: Class I Recall - Motor Stalls During Infusion |
DEVICE WARNING |
| 8.23.12 |
303, Alaris Pump Module, Model 8100: Class I Recall - Potential for Pump Malfunction To Stop Infusion |
DEVICE WARNING |
| 8.21.12 |
Synthes Hemostatic Bone Putty: Class I Recall - Potential for Putty to Ignite |
DEVICE ALERT |
| 8.21.12 |
Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject: Recall- May Contain More Than the Intended Fill Volume |
DRUG WARNING |
| 8.16.12 |
FDA Approves Extended-Release and Long-Acting Opioids Risk Evaluation and Mitigation Strategy (REMS): Labeling Changes |
DRUG WARNING |
| 8.9.12 |
CareFusion Alaris PC Unit, Model 8015: Class I Recall - Error Code |
DEVICE WARNING |
| 8.7.12 |
B. Braun Infusomat Space Infusion System: Class I Recall - Potential for Breakage of Anti Free Flow Clip Catch |
DEVICE WARNING |
| 8.1.12 |
FDA Safety Communication: Tubing and Luer Misconnections- Preventing Dangerous Medical Errors |
CAUTIONARY NOTICE |
| 7.24.12 |
CDC Issues MMWR on Invasive Staphylococcus aureus Infections Associated with Pain Injections and Reuse of Single-Dose Vials— Arizona and Delaware, 2012 |
WARNING |
| 7.18.12 |
Maquet Medical Systems USA FLOW-i Anesthesia System- Class 1 Recall |
DEVICE WARNING |
| 6.06.12 |
Reumofan Plus: Recall - Undeclared Drug Ingredient |
DRUG WARNING |
| 5.25.12 |
Hospira Carpuject Pre-filled Cartridges: Drug Alert- Products May Contain More Than the Intended Fill Volume |
ALERT |
| 5.18.12 |
Levaquin (Levofloxacin) Tablets, Oral Solution and Injection: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 5.18.12 |
Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject: Recall- May Contain More Than the Intended Fill Volume |
DRUG WARNING |
| 2.6.12 |
Covidien Contraindicates the Use of Duet TRS for Thoracic Surgery, Implements a Voluntary Recall |
DEVICE CAUTIONARY NOTICE |
| 1.11.12 |
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory—Potential Safety Risk |
ALERT |
| 1.5.12 |
ShoulderFlex Massager: Warning-Risk of Strangulation |
DEVICE CAUTIONARY NOTICE |
| 12.21.11 |
Lioresal (baclofen) intrathecal: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 12.21.11 |
Dilantin (phenytoin): Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 12.14.11 |
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events |
DRUG CAUTIONARY NOTICE |
| 11.10.11 |
Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury |
ALERT |
| 10.17.11 |
Cymbalta (duloxetine hydrochloride): Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 10.17.11 |
FDA Safety Communication: Preventing Surgical Fires |
WARNING |
| 9.20.11 |
Zofran (ondansetron): Drug Safety Communication ‐ Risk of Abnormal Heart Rhythms |
DRUG CAUTIONARY NOTICE |
| 9.14.11 |
Mobic (meloxicam) Tablets and Oral Suspension:
Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 9.14.11 |
Neurontin (gabapentin) Capsules, Tablets and Oral Solution: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 9.14.11 |
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 9.14.11 |
Celexa (citalopram hydrobromide) Tablets and Oral Solution: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 9.12.11 |
Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class 1 Recall |
DEVICE CAUTIONARY NOTICE |
| 9.12.11 |
Tumor Necrosis Factor‐alpha (TNFα) Blockers: Label Change ‐ Boxed Warning Updated for Risk of Infection from Legionella and Listeria |
DRUG CAUTIONARY NOTICE |
| 9.7.11 |
Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment |
DRUG CAUTIONARY NOTICE |
| 8.31.11 |
H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing |
DRUG CAUTIONARY NOTICE |
| 8.30.11 |
Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses |
DRUG WARNING |
| 8.9.11 |
Methylene Blue
Drug Safety Communication ‐ Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications |
DRUG WARNING |
| 8.9.11 |
Zyvox (linezolid)
Drug Safety Communication ‐ Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications |
DRUG WARNING |
| 7.29.11 |
Tribenzor (olmesartan medoxomil / amlodipine / hydrochlorothiazide) tablets: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Feraheme (ferumoxytol) Injection: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Ditropan XL (oxybutynin chloride) tablets: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Benicar (olmesartan medoxomil) Tablets: Labeling Changes |
DRUG WARNING |
| 7.29.11 |
Zocor (simvastatin) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Zmax (azithromycin extended release) for oral suspension: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Vytorin (ezetimibe/simvastatin) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Simcor (niacin extended‐release/simvastatin) tablets:
Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Prilosec (omeprazole) Delayed‐Release Capsules, Prilosec (omeprazole magnesium) For Delayed Release Oral Suspension: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Pepcid (famotidine) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Nexium (esomeprazole magnesium) for delayed‐release oral suspension, delayedrelease capsules and (esomeprazole sodium) for injection: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Multaq (dronedarone hydrochloride) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Diovan HCT (valsartan/hydrochlorothiazide) and
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Diovan (valsartan) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Corgard (nadolol) tablets and Corzide (nadolol and bendroflumethiazide) tablets: Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Avalide (irbesartan/hydrochlorothiazide) tablets:
Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.29.11 |
Atacand (candesartan cilexetil) tablets and Atacand HCT (candesartan/cilexetil hydrochlorothiazide) tablets: abeling Changes |
DRUG CAUTIONARY NOTICE |
| 7.26.11 |
Chantix (varenicline): Label Change ‐ Risk of Certain Cardiovascular Adverse Events |
DRUG CAUTIONARY NOTICE |
| 7.21.11 |
Oral Osteoporosis Drugs (bisphosphonates): Drug Communication – Potential Increased Risk of Esophageal Cancer |
DRUG CAUTIONARY NOTICE |
| 7.20.11 |
Multaq (dronedarone): Drug Safety Communication ‐
Increased Risk of Death or Serious Cardiovascular Events |
DRUG WARNING |
| 6.30.11 |
Tylenol Extra Strength Caplets, 225 count bottles:
Recall - Uncharacteristic Odor |
DRUG CAUTIONARY NOTICE |
| 6.27.11 |
Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ): Recall - Some Bottles Contain Different St |
DRUG WARNING |
| 6.27.11 |
Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall ‐ Bottle Mislabeled |
DRUG CAUTIONARY NOTICE |
| 6.24.11 |
Erythropoiesis‐Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication ‐ Modified Dosing Recommendations |
DRUG WARNING |
| 6.21.11 |
Chantix (varenicline): Label Change – Risk of Certain Cardiovascular Adverse Events |
DRUG NOTICE |
| 5.3.11 |
Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency |
DRUG CAUTIONARY NOTICE |
| 4.20.11 |
Neurontin (gabapentin) Capsules, Tablets and Oral Solution: Adverse Reactions – Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 4.20.11 |
Lioresal (baclofen) intrathecal: Warnings and Precautions – Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 3.22.11 |
American Regent Initiates Voluntary Nationwide Recall of
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials |
DRUG CAUTIONARY NOTICE |
| 3.22.11 |
Flector Patch (diclofenac epolamine topical patch):
Contraindications – Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 3.22.11 |
Voltaren (diclofenac sodium enteric-coated) Tablets
Voltaren-XR (diclofenac sodium extended release) Tablets Cataflam (diclofenac potassium immediate-release) Tablets: Precautions – Labeling Changes |
DRUG CAUTIONARY NOTICE |
| 3.4.11 |
FDA Communication: Update on Serious Complications Associated with Negative Wound Pressure Therapy Systems |
DRUG CAUTIONARY NOTICE |
| 3.4.11 |
Expansion of Voluntary Nationwide Recall – Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin |
DRUG CAUTIONARY NOTICE |
| 2.18.11 |
Warfarin Sodium Tablets (Jantoven), 3mg Recall - Mislabeled Bottles Containing Higher Dosage |
DRUG CAUTIONARY NOTICE |
| 2.18.11 |
Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall |
DEVICE CAUTIONARY NOTICE |
| 2.7.11 |
Hydrocodone Bitartrate and Acetaminophen Tablets,
Phenobarbital Tablets by Qualitest: Recall – Incorrect Package Labeling |
DRUG NOTICE |
| 1.18.11 |
Remicade (infliximab) for Intravenous (IV) Injection:
Warnings and Adverse Reactions – Labeling Changes |
DRUG WARNING |
| 1.17.11 |
Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication |
DRUG WARNING |
| 1.11.11 |
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error – Reports of Accidental Overdose |
DRUG WARNING |
| 12.10.10 |
Dexamethasone Sodium Phosphate Injection, 4mg/mL, 30 mL Multiple Dose Vial: Recall Due to Particulates in Product |
DRUG CAUTIONARY NOTICE |
| 12.10.10 |
Drug Safety Labeling Changes -
Rozerem (Ramelteon) Tablets |
DRUG CAUTIONARY NOTICE |
| 12.10.10 |
Drug Safety Labeling Changes - OxyContin (Oxycodone Hydrochloride Controlled-Release) Tablets |
DRUG CAUTIONARY NOTICE |
| 11.19.20 |
Propoxyphene: Withdrawal - Risk of Cardiac Toxicity
Sold as Darvon, Darvocet, and generics |
DRUG WARNING |
| 11.08.10 |
Heparin Sodium (B. Braun): Recall ‐ Trace Contaminant |
DRUG CAUTIONARY NOTICE |
| 10.25.10 |
Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified |
DRUG CAUTIONARY NOTICE |
| 10.20.10 |
Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility |
DRUG CAUTIONARY NOTICE |
| 10.19.10 |
Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Update |
DRUG CAUTIONARY NOTICE |
| 9.30.10 |
Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials |
DRUG CAUTIONARY NOTICE |
| 9.22.10 |
Drug Safety Labeling Changes - Heparin Sodium in Dextrose injection and in Sodium Chloride injection |
DRUG CAUTIONARY NOTICE |
| 9.13.10 |
Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis |
DRUG WARNING |
| 7.21.10 |
Coumadin 1 mg Tablet Blister Packs Recall |
DRUG ALERT |
| 7.21.10 |
Air- or Gas-Pressurized Spray Devices - Risk of Air or Gas Embolism |
DEVICE CAUTIONARY NOTICE |
| 7.21.10 |
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury |
DRUG WARNING |
| 6.07.10 |
Intravenous Medications Manufactured by Claris:
Recall Due to Contamination of Products |
DRUG WARNING |
| 5.26.10 |
Drug Safety Labeling Changes ‐ Proton Pump Inhibitors (PPI) |
DRUG CAUTIONARY NOTICE |
| 5.25.10 |
Drug Safety Labeling Changes ‐ Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen) |
DRUG CAUTIONARY NOTICE |
| 5.24.10 |
Drug Safety Labeling Changes - Zonegran (zonisamide) capsules |
DRUG CAUTIONARY NOTICE |
| 5.24.10 |
Drug Safety Labeling Changes - Tisseel (fibrin sealant) |
DRUG CAUTIONARY NOTICE |
| 5.14.10 |
Class I Recall: GE Healthcare Aisys and Avance Anesthesia Systems |
DEVICE WARNING |
| 5.06.10 |
Baxter Colleague Infusion Pumps: FDA Ordering Recall |
DEVICE CAUTIONARY NOTICE |
| 5.06.10 |
Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Boniva (ibandronate sodium) tablets |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Coumadin (warfarin sodium) tablets and injection |
DRUG CAUTIONARY NOTICE |
| 3.02.10 |
Kenalog (triamcinolone acetonide) injectable suspension |
DRUG CAUTIONARY NOTICE |
| 2.19.10 |
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp Drug Safety Communication |
DRUG CAUTIONARY NOTICE |
| 1.21.10 |
McNeil Consumer Healthcare OTC products:
Recall – 12/09 recall of Tylenol arthritis caplets now expanded to multiple other products |
DRUG CAUTIONARY NOTICE |
| 1.06.10 |
Thermoflect Blankets and product line –
Recall: Products are not to be used in MR environment |
DEVICE CAUTIONARY NOTICE |
| 1.06.10 |
Tylenol Arthritis Pain Caplet 100 count: Recall of all lots due to reports of odor associated with nausea, vomiting and diarrhea |
DRUG CAUTIONARY NOTICE |