Safety Alerts & Recalls

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Latest Alerts

FDA Says Midodrine Will Continue to Be Available While Additional Studies Are Conducted
In August 2010, the Food and Drug Administration (FDA) proposed to withdraw the approval of the low-blood pressure medicine midodrine (ProAmantine) because required post-marketing studies on the drug's effectiveness had not been done. This week, the FDA announced that the proposal to withdraw approval of midodrine has been put on hold. The FDA’s Center for Drug Evaluation and Research (CDER) and the manufacturer Shire have come to an agreement for Shire to conduct two additional clinical trials to verify the clinical benefit of the drug ProAmatine (midodrine HCL). Midodrine remains approved and available in the marketplace. To reassure patients and their doctors, FDA has stated that as the regulatory process moves forward, continued patient access to midodrine is a key agency priority. Midodrine is used to treat the low blood pressure condition called orthostatic hypotension. Midodrine is marketed as ProAmatine by Shire Development Inc. and generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm290825.htm To view the August 2010 MediGuard Safety Alert, please visit: http://www.mediguard.org/alerts/alert/1053.html
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Healthcare Professionals Advised That a Single Batch Of Clexane Syringe Needle Caps May Be Difficult To Remove
The Medicines and Healthcare products Regulatory Agency (MHRA) has written to healthcare professionals to alert them that the removal of needle caps on some Clexane (enoxaparin) 40mg/0.4ml syringes from a single batch may require more force than usual. The affected batch number is 1LH35 and can still safely be used, but additional vigilance is required when preparing syringes from this batch. The quality of the contents of the syringes is not affected in any way. Clexane contains the medication enoxaparin which is an anticoagulant used to prevent and treat blood clots. For more information please visit: http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON143682
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Date Published Title Drug Source
2012-02-16 FDA Says Midodrine Will Continue to Be Available While Additional Studies Are Conducted Midodrine Hydrochloride FDA
2012-02-17 Healthcare Professionals Advised That a Single Batch Of Clexane Syringe Needle Caps May Be Difficult To Remove Lovenox MHRA
2012-02-19 McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints Manufacturer
2012-02-22 McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints Acetaminophen Manufacturer
2012-02-22 McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints Manufacturer
2012-02-26 FDA Issues Consumer Update about Grapefruit Juice and Medicine Interactions Cyclosporine FDA
2012-02-27 Glenmark Generics Recalls Birth Control Pills Due To Packaging Error that May Increase Risk of Unintended Pregnancies Ethinylestradiol with Norgestimate FDA
2012-02-28 FDA Provides Safety Advice for Statins Atorvastatin FDA
2012-02-28 FDA Revises Dose Limitations for Lovastatin (Mevacor) and Lovastatin/Niacin (Advicor) Lovastatin FDA
2012-02-29 New Study Suggests Sleeping Pills May Raise Risk of Death Eszopiclone MediGuard CRT
2012-02-29 GlaxoSmithKline Recalls All Lots of DynaCirc CR (Isradipine) Tablets Isradipine Manufacturer
2012-02-29 Prevnar Vaccine Recall Unlikely to Pose Health Risk Pneumococcal Conjugate Vaccine FDA
2012-03-02 FDA Warns about Drug Interaction - Taking Both Statins and HIV or Hepatitis C Drugs Increases Risk of Muscle Injury Indinavir FDA
2012-03-05 New Jersey CVS Pharmacy Dispenses Breast Cancer Medicine Instead of Kids' Fluoride Tablets Sodium Fluoride MediGuard CRT
2012-03-07 Sandoz Inc. Recalls Select Lots of Cefprozil Powder for Oral Suspension, USP 125 mg/5 mL and 250 mg/5 mL Cefprozil FDA
2012-03-07 GlaxoSmithKline Inc. Recalls Several Lots of Ventolin HFA (Albuterol Sulfate) 90 mcg Albuterol FDA
2012-03-07 Sun Pharmaceutical Industries Recalls Several Lots of Azelastine Hydrochloride Ophthalmic Solution, 0.05% Azelastine FDA
2012-03-08 FDA Warns that Skin Lightening and Anti-Aging Products Found to Contain Mercury Royal Jelly FDA
2012-03-19 Bausch & Lomb Recalls Single Lot of Brimonidine Tartrate Ophthalmic Solution 0.2% Brimonidine FDA
2012-03-19 Teva Pharmaceuticals Recalls Single Lot of Flutamide Capsules 125 mg Flutamide FDA