Industry News & Alerts

New dosing and a recommendation to avoid driving the day after Ambien CR use

Opana ER  Extended-Release Tablets was not withdrawn for safety or effectiveness

Nutraceutical company XYMOGEN in Orlando, Fla., is recalling artriphen

Practices at The Compounding Shop in FL raise concerns about sterility assurance 

Versions of Botox that are not approved by the FDA are being sold to medical practices. 

Nora Apothecary & Alternative Therapies recall of all sterile drug products 

 FDA announces nationwide recall by Balanced Solutions Compounding Pharmacy 

Agency will not approve generics to original OxyContin

Voluntary Nationwide Recall of All Lots of All Sterile Products 

Results of compounding pharmacies inspections 

Campaign to raise awareness of the dangers of medicines from fake online pharmacies

 The Drug Enforcement Administration has scheduled another Prescription Drug Take-Back Day April 27

Recall of All Sterile Compounded Products Dispensed Since January  2013 

Recall Compounded Products Due To Potential Mold Contamination

 Clinical Specialties is voluntarily recalling all lots of all sterile products 

FDA offers some tip-offs to help you identify rip-offs

Possible Increased Risk of Pancreatitis and Pre-Cancerous Pancreas Findings 

Azithromycin can cause abnormal changes in the electrical activity of the heart

 Recalling all lots of Tablets Due to Undeclared Drug Ingredients

 Governor’s budget provides resources for pharmacy inspections and oversight

FDA warns about serious blood disorder resulting from misuse of Opana ER

FDA requires lower recommended doses for drugs containing zolpidem 

Pays to Resolve Kickback Allegations in Connection with Promotion of Its Drugs

 Recall Impacts Three Lots of Hydrocodone Bitartrate and Acetaminophen Tablets

Pradaxa should not be used to prevent stroke or blood clots in patients 

Reumofan Plus is being relabeled and sold under the name “WOW"

Serious skin reactions after combination treatment 

FDA is informing the public about the results of a large, combined analysis

Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets

Ranbaxy Pharmaceuticals Inc. is conducting a recall for Atorvastatin

 Ameridose announced a voluntary recall of any unexpired products in circulation

Emergency Suspension Order (ESO) of Rejuvi Pharmaceuticals, Inc.

 The FDA approved Fycompa tablets to treat partial onset seizures in patients with epilepsy 

 NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR™

 FDA provides NECC Customer List

The FDA recently found cases of blood disorders occurred in abusers of Opana ER

Meningitis Outbreak: Additional Patient Notification Advised

The  FDA took action this week against Internet pharmacies

U.S. Files Criminal Charges in Connection with Misbranded Drug Shipment

Investigation of Aspergillus meningitis among patients who received medication

Subpotent; some patches may not contain fentanyl gel  

 Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40

Sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name

Pharmaceutical manufacturer may have distributed foreign tablets 

RB confirms the company is discontinuing Suboxone Tablets in the US

The Drug Enforcement Administration (DEA) has scheduled another National Prescription Drug Take-Back Day

Tablets may contain higher than indicated amounts of the ingredients.

FDA notified healthcare profesionals about increased risk with Mirapex

Products applied to the skin have been reported to cause rare cases of skin injuries.

Tablets, exceed the weight specification and could be super-potent

Endo Pharmaceuticals Announces Reformulated Version of OPANA® ER with INTAC® Technology Designed to be Crush-Resistant Accounts for more than 90 Percent of OPANA ER Total Prescription Volume

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration (FDA)

FDA Approves NUCYNTA® ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

The FDA issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements.

 The U.S. Food and Drug Administration today approved the first generic version of Actos tablets.

The FDA has approved label changes to a number of opioids to reflect the new REMS requirements.

Tizanidine Recall: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

The U.S. Food and Drug Administration today approved Tudorza Pressair for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

FDA approved a risk evaluation and mitigation strategy for extended-release and long-acting opioid medications.

Almost one-third of prescription painkiller overdose deaths involve methadone. Six times as many people died of methadone overdoses in 2009 than a decade before. Learn the facts and what you can do to address this problem

First generic pregabalin products approved.

The U.S. Food and Drug Administration today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone.

The FDA issued draft guidance to manufacturers of OTC acetaminophen products, providing alternative language to the liver warning section of the product’s labeling.

Important changes are coming to Vicodin

Undeclared Drug Ingredient

Tablets purchased on the Internet contain wrong active ingredients

Prescriptions Distributed by Franck’s Pharmacy From November 21, 2011 to May 21, 2012

FDA is reviewing the results from a New England Journal of Medicine study reporting a small increase in cardiovascular deaths, in persons treated with a 5-day course of azithromycin

FDA approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke

New Warning and Contraindication for blood pressure medicines containing aliskiren

FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (“Patches”)

related to a potential risk of abnormal heart rhythms with high doses

Changes were made to the labels to provide the public with more information for the safe and effective use of statins.

This temporary shortage is not related to the efficacy or safety of Voltaren Gel.

Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

FDA advises of potential safety risk associated with certain opiate products manufactured for Endo Pharmaceuticals by Novartis Consumer Health.

for transmucosal immediate-release fentanyl (TIRF) medicines

Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events

(atorvastatin calcium tablets)
 

Watson Pharmaceuticals Inc. announced FDA approval for its Abbreviated New Drug Application for morphine sulfate ER capsules USP

FDA warns that that the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke.

NIH announces results from first large scale study on treatment of prescription opioid addiction

Kill more Americans than heroin and cocaine combined

Read the FDA Warning Letter and Notice of Violation Sent to Pfizer regarding Chantix^®, Caduet^® and Norvasc^®

Serious allergic reactions

Abnormal Heart Rhythms Associated With High Doses

(tapentadol extended-release tablets) receives FDA approval for the management of moderate to severe chronic pain

To treat specific form of urinary incontinence

Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications

Mcneil Consumer Healthcare Announces Plans For New Dosing Instructions For Tylenol® Products

to treat chronic obstructive pulmonary disease

 Potiga (ezogabine) tablets approved by FDA for use as add-on medication to treat seizures associated with epilepsy

Increased Risk of Death or Serious Cardiovascular Events

Potential Increased Risk of Esophageal Cancer

First Fentanyl Nasal Spray - for the management of breakthrough pain in cancer patients

to prevent tetanus, diphtheria, and pertussis in older people

to reduce risk of blood clots after hip, knee replacements

Uncharacteristic Odor

(USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg):  Bottle Mislabeled

Some Bottles Contain Different Strength Tablets

Recall - Uncharacteristic Odor

Oxycodone HCL, USP

REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis

Label Change - Increased Risk of Prostate Cancer

Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet and Avandaryl

The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets

FDA approves Horizant to treat restless legs syndrome

Improvements implement FSMA requirement

McNeil Consumer Healthcare announces voluntary recall of certain OTC products

Unapproved Product May Contain Dangerously High Levels of Vitamins A and D

Voluntary Nationwide Recall  Due to Possible Mislabeling
 

King Pharmaceuticals Inc. has recalled Embeda® Extended Release Capsules CII

Maternal Treatment with Opioid Analgesics and Risk for Birth Defects

FDA approves Edarbi to treat high blood pressure

Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin

Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall

Product is not FDA-approved

 Covidien received approval of its Abbreviated New Drug Application (ANDA) for FTS patch

Qualitest Pharmaceuticals

 REMS - Risk of Cardiovascular Events

Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia

FDA approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults

Bristol-Myers Squibb and partner sanofi-aventis are voluntarily withdrawing certain lots of AVALIDE®

Certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, TYLENOL® Cold, TYLENOL® Allergy, TYLENOL® Sinus, BENADRYL®, SINUTAB® Sinus, SUDAFED PE® and ROLAIDS®

Severe liver injury associated with the use of dronedarone

Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure

100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose

The FDA approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer.

Mislabeled Unit Dose Vials; voluntary recall in 25, 30, and 60 unit dose vials        

Pfizer recalled specific bottles of LIPITOR (40 mg only)

Potential for Accidental Ingestion by Children

McNeil recalls all lots of Rolaids® extra strength softchews, extra strength plus gas softchews, and multi-symptom plus anti-gas softchews

Refenesen Expectorant;Select Brand Mucus Relief Expectorant; QC Medifin Expectorant;Leader Cough Tabs Expectorant

View recent recalls from McNeil Consumer Healthcare

Xanodyne Pharmaceuticals Inc. has withdrawn the prescription pain medication propoxyphene from the US market at the request of the FDA.

Safety update for osteoporosis drugs, bisphosphonates and atypical fractures

The FDA warns that Lamictal can cause aseptic meningitis.

Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

21 lots of over-the-counter medicines sold in US, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica are recalled.

Serious side effects reported when used to treat or prevent night time leg cramps

The U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.

P&G Voluntarily Recalls 4 Hour Decongestant Nasal Spray in the United States

FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events

Blacksmith Brands Announces Nationwide Voluntary Recall Of Four PediaCare Children's Products

Completed safety review of Xenical/Alli (orlistat) and severe liver injury.

Goal is to expand online distribution of Agency’s consumer health information.

The FDA and the NIH launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government.

Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol.

Proton Pump Inhibitors Class Labeling Change including Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, Vimovo, Prilosec OTC, Zegerid OTC, and Prevacid 24HR

Change to Dexilant is part of FDA effort to prevent medication errors.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

The FDA provides answers to questions about a new approved formulation of the controlled-release drug OxyContin.

The FDA approved a new formulation of the controlled-release drug OxyContin designed to help discourage abuse.

FDA warned company about making medical claims for bee-derived products.

A listing of recent new and generic drugs approved by the FDA.

Maalox product maker agrees to name change to avoid confusion.

FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain. Approval is part of Agency’s unapproved drugs initiative.

Alli 60 mg capsules (120 count refill kit): Counterfeit Product
 

Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
 

McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji