Monthly Archives: February 2012

Flight Medical V240040029 Cable for Newport HT50 Ventilator Class I Recall

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Translation Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator: Class I Recall – Cable May Cause an Electrical Shortage That can Cause Ventilators to Shutdown Unexpectedly   ISSUE: The recalled cable may cause an electrical shortage that can cause Newport … Continue reading

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Posted in Emergency Rooms, FDA 2012, FDA Recall, Hospitals, Risk Manager | Tagged , , , , , , , | Comments Off

Statin Drugs Drug Safety Communication Class Labeling Change

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TranslationStatin Drugs – Drug Safety Communication: Class Labeling Change AUDIENCE: Cardiology, Family Practice, Patients ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver … Continue reading

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Posted in Cardiology, Family Practice, FDA 2012, FDA Label Change, FDA Safety Communication | Tagged , , , , , , , , , , , , , , , , , , , , , | Comments Off

Norgestimate and Ethinyl Estradiol Tablets Recall

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TranslationNorgestimate and Ethinyl Estradiol Tablets: Recall – Packaging Error, Potential for Incorrect Dosing Regimen AUDIENCE: OB/GYN, Pharmacy, Patient ISSUE: Glenmark Generics Inc. issued a nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 … Continue reading

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Cytarabine for Injection 1 gm vial Bedford Labs Recall

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Translation Cytarabine for Injection, 1 gm/vial [Bedford Labs]: Recall: Risk of Lack of Sterility ISSUE: Bedford Laboratories announced a nationwide recall of three lots of cytarabine for injection—2066986, 2111675, and 2131148—because vials have a potential risk of a lack of sterility. The … Continue reading

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Posted in Clinics, Emergency Rooms, Family Practice, FDA 2012, FDA Recall | Tagged , , , , , , , , , , , , | Comments Off

Phenylephrine HCl Injection USP 1% 5 mL Vial Recall

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TranslationUPDATED 02/23/2012] Phenylephrine HCl Injection, USP, 1% 5 mL Vial, (Lot# 0693) recalled. AUDIENCE: Pharmacy ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels … Continue reading

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Posted in Clinics, Emergency Rooms, FDA 2012, Hospitals, Pharmacy | Tagged , , , , , , , , , , , , , , | Comments Off

Infants TYLENOL Oral Suspension 1 oz Grape Recall

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TranslationInfants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall – Dosing System Complaints AUDIENCE: Consumer, Pharmacy ISSUE: McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There … Continue reading

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Posted in Consumer Products, FDA 2012, FDA Recall, Pharmacy | Tagged , , , , , , , , , , , | Comments Off

Avastin bevacizumab Counterfeit Product

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TranslationAvastin (bevacizumab): Counterfeit Product – FDA Issues Letters to 19 Medical Practices AUDIENCE: Oncology, Pharmacy, Patient ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by … Continue reading

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Posted in FDA 2012, FDA Warning, Oncology, Pharmacy | Tagged , , , , , , , , , , , , | Comments Off

Wholistic Herbs Inc Koff and Kold Kold Sore Spray Recall

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TranslationWholistic Herbs, Inc. “Koff and Kold” and “Kold Sore” Spray: Recall – Non-Sterile Products AUDIENCE: Consumer ISSUE: Wholistic Herbs Inc. notified the public it is recalling all quantities of “Koff & Kold” spray with herbal extract and “Kold Sore” spray … Continue reading

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Victrelis and Ritonavir Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs Drug Safety Communication

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TranslationVictrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication – Drug Interactions AUDIENCE: Infectious Disease, Pharmacy ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis … Continue reading

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Posted in FDA 2012, FDA Notice, FDA Safety Communication, Infectious Disease, Pharmacy | Tagged , , , , , , , | Comments Off

Proton Pump Inhibitors PPIs Drug Safety Communication

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TranslationProton Pump Inhibitors (PPIs) – Drug Safety Communication: Clostridum Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs AcipHex (rabeprazole sodium) Dexilant (dexlansoprazole) Nexium (esomeprazole magnesium)  Omeprazole (omeprazole) Over-the-Counter (OTC) Prevacid (lansoprazole) and OTC Prevacid 24hr Prilosec (omeprazole)  and … Continue reading

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Posted in Consumer Products, Family Practice, FDA 2012, FDA Notice, FDA Safety Communication, FDA Warning, Gastroenterology | Tagged , , , , , , , , , , , , , , , , , | Comments Off