Monthly Archives: January 2012

Vitaflo USA Renastart Recall

PinterestShare

Translation Vitaflo USA Renastart: Recall – Possible Health Risk Due To Incorrectly Labeled Cans AUDIENCE: Pediatrics, Health Professionals, Consumers ISSUE: Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832, because some of the … Continue reading

PinterestShare
Posted in Consumer Products, FDA Recall, Pediatrics | Tagged , , , , , , , | Comments Off

Treanda bendamustine HCL Recall

PinterestShare

TranslationTreanda (bendamustine HCL): Recall – Particulate Matter in Vial AUDIENCE: Risk Manager, Oncology, Pharmacy ISSUE: Cephalon, Inc. notified healthcare professionals of a recall of Treanda (bendamustine HCL) for Injection 25mg/8mL, lot TB30111, expiration date 12/2012. This product lot is being … Continue reading

PinterestShare
Posted in FDA 2012, FDA Recall, Oncology, Pharmacy, Risk Manager | Tagged , , , , , , , , , , | Comments Off

Tysabri (natalizumab) Drug Safety Communication

PinterestShare

TranslationTysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) AUDIENCE: Neurology, Gastroenterology ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal … Continue reading

PinterestShare
Posted in FDA 2012, FDA Notice, Gastroenterology, Neurology | Tagged , , , , , , , , | Comments Off

Perfect Image Solutions Topical Hair Regrowth Products Recall

PinterestShare

TranslationPerfect Image Solutions Topical Hair Regrowth Products: Recall – Unapproved Drugs, Risk of Health Hazards Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60ml Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL Men’s Minoxidil 5% Azelaic 5% Hair regrowth … Continue reading

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

Vagifresh Ball Vagifresh Gel Female One Recall

PinterestShare

TranslationVagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination AUDIENCE: Consumer, OB/GYN ISSUE: USA Far Ocean Group Inc. notified the public of a recall of Vagifresh Ball and Vagifresh Gel, sold as cosmetics. Vagifresh Gel was found … Continue reading

PinterestShare
Posted in Consumer Products, FDA 2012, FDA Recall, FDA Warning, OBGYN | Tagged , , , , , , , , , , , , , , | Comments Off

The Biggest Drug Recalls of 2011

PinterestShare

TranslationThe Biggest Drug Recalls of 2011 Always be careful when you take your medications. Make sure you talk about it with your doctor or make some research because some of them may worsen the condition or risk your health instead … Continue reading

PinterestShare
Posted in FDA 2011, FDA Recall | Tagged , , , , , , , | Comments Off

Adcetris (brentuximab vedotin) Drug Safety Communication

PinterestShare

TranslationAdcetris (brentuximab vedotin): Drug Safety Communication – Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity AUDIENCE: Oncology, Hematology, Neurology ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in … Continue reading

PinterestShare
Posted in FDA 2011, FDA Label Change, FDA Notice, FDA Warning, Hematology, Neurology, Oncology | Tagged , , , , , , , , , | Comments Off

December 2011 Safety Labeling Change

PinterestShare

TranslationThe MedWatch December 2011 Safety Labeling Changes posting includes 40 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading

PinterestShare
Posted in FDA 2011, FDA Label Change, FDA Warning | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off

Bedford Laboratories Polymyxin B Vecuronium Bromide Recall

PinterestShare

TranslationBedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall – Glass Particles AUDIENCE: Pharmacy, Risk Manager ISSUE: Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were … Continue reading

PinterestShare
Posted in FDA 2011, FDA Recall, Pharmacy, Risk Manager | Tagged , , , , , , , , | Comments Off

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health

PinterestShare

TranslationEndo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory – Potential Safety Risk Including the following products: Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII Opana (oxymorphone hydrochloride) CII Oxymorphone hydrochloride Tablets CII PERCOCET (oxycodone hydrochloride and acetaminophen USP) … Continue reading

PinterestShare
Posted in Consumer Products, FDA 2011, FDA Warning, Pharmacy | Tagged , , , , , , , , , , , , , | Comments Off