Industry News & Alerts

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