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Injectable Products by Mylan: Recall - Presence of Particulate Matter

April 24, 2015

Audience: Pharmacy, Oncology, Rheumatology. including certain lots of: Gemcitabine for Injection Carboplatin Injection Methotrexate Injection Cytarabine Injection See the press release for a listing of the product strength, NDC, and lot numbers affected by this recall. Some products may be packaged with a Pfizer Injectables label (see Background below)   [Posted 04/24/2015] ISSUE: Mylan N.V. is...

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Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials

April 24, 2015

Audience: Pharmacy, Anesthesiology, Veterinary . ISSUE: Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as...

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Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing

April 22, 2015

[Posted 04/23/2015] AUDIENCE: Infectious Disease, Emergency Medicine ISSUE: The FDA has not cleared or approved the Ebola Virus One-Step Test Kits for use or sale. The results obtained from these test kits have not been demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection. A false positive result may be life-threatening by potentially placing the patient in an...

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Mucinex Fast-MAX Products: Recall - Incorrect Labeling

April 22, 2015

Audience: Consumer. Including certain lots of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat [Posted 04/22/2015] ISSUE: RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe...

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Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication

April 17, 2015

Audience: Health Professional, Pharmacy, Consumer, Veterinary. [Posted 04/17/2015] ISSUE: FDA is alerting pet owners, veterinarians, health care providers and pharmacists that pets are at risk of illness and death when exposed to topical pain medications containing the nonsteroidal anti-inflammatory drug (NSAID) flurbiprofen. People using these medications should use care when applying them in a household with...

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Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter

April 10, 2015

Audience: Pharmacy, Risk Manager, Nursing. [Posted 04/10/2015] ISSUE:  Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the...

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IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients

April 8, 2015

Audience: Risk Manager, Health Professionals, Pharmacy. UPDATED 04/08/2015. FDA’s laboratory analysis of Wallcur’s simulated Practi-0.9% sodium chloride IV is now complete. FDA sampled 11 of Wallcur’s simulated saline solution bags and identified large amounts of endotoxin and significant bacterial contamination in the samples. These include bacteria (e.g., Bacillus spp., Brevundimonas sp., Pseudomonas...

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Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance

April 2, 2015

Audience: Health Professional, Pharmacy, Veterinary, Patient. [Posted 04/02/2015] ISSUE: FDA is joining the North Carolina Board of Pharmacy (NC BOP) to urge health care professionals, including veterinarians, and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., Fayetteville, North Carolina. In an inspection conducted in March by the NC BOP, state...

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Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed

March 31, 2015

Audience: Hematology, Nephrology, Pharmacy. ISSUE: FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). FDA changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of...

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Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone

March 24, 2015

Audience: Cardiology, Infectious Disease, Gastroenterology, Pharmacy. [Posted 03/24/2015] ISSUE: FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection....

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Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug

March 23, 2015

Audience: Psychiatry, Pharmacy, Patient. ISSUE: FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following...

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Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks

March 19, 2015

Audience: Consumer, Pharmacy, Health Professional. ISSUE: FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.  Asthma is a serious, chronic lung condition. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing,...

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Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination

March 12, 2015

Audience: Pharmacy, Risk Manager. ISSUE: Hospira initiated a voluntary recall of one lot of Lactated Ringer's Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate was confirmed as a common non-toxic, non-invasive...

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Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene

March 10, 2015

Audience: Oncology, Pharmacy, Nursing, Risk Manager. [Posted 03/10/2015] ISSUE: FDA is warning health care professionals not to use Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTD), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). Most marketed CSTDs contain either polycarbonate or ABS and are not compatible with Treanda...

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Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction

March 9, 2015

Audience: Family Practice, Patient, Pulmonology. ISSUE: FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in...

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Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling

March 6, 2015

Audience: Pharmacy, Risk Manager. ISSUE: Hospira announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be...

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0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter

March 6, 2015

Audience: Pharmacy, Risk Manager. ISSUE: Hospira announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry 1MAR2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution. To date, Hospira...

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Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning

March 3, 2015

UPDATED 03/04/2015: The Safety Communication has been updated. Please refer to the FDA Safety Communication for details. Updated Information for Healthcare Providers Regarding Duodenocopes is provided. UPDATED 02/23/2015. The Safety Communication has been updated. Please refer to the FDA Safety Communication for details. [Posted 02/19/2015] AUDIENCE: Gastroenterology, Surgery, Nursing, Risk Manager, Biomedical...

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Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke

March 3, 2015

Audience: Health Professional, Endocrinology, Urology, Family Practice, Patient. [This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.]  [Posted 03/03/2015] ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their...

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Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall - Lack of Sterility Assurance

February 25, 2015

Audience: Pharmacy. ISSUE: Heritage Pharmaceuticals Inc. announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Heritage has initiated this voluntary recall to the...

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