Safety Alerts & Recalls

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Watson Laboratories Recalls Several Lots of Birth Control Pills: Zovia, Lutera, Zenchent, and Necon
Watson Laboratories has recalled several lots of birth control pills because routine testing found that these lots may be contaminated with hydrochlorothiazide, a diuretic medicine used to control blood pressure. The following drugs product lots have been recalled: Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets, 1 mg/35 mcg: Lot numbers 515622AA, 515623AA, and 515623BA Lutera (levonorgestrel and ethinyl estradiol) Tablets, 0.1 mg/0.02 mg: Lot numbers 517921AA, 517921AB, 517922AA, 517922AB, 517923AA, and 517923AB Zenchent (norethindrone and ethinyl estradiol) Tablets, 0.4 mg/0.035 mg: Lot number 514767AA Necon 10/11 (norethindrone and ethinyl estradiol) Tablets, 0.5 mg/35 mcg, 1 mg/35 mcg: Lot number 512642B Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets, 1 mg/35 mcg: Lot number 514743AB Zovia, Lutera, Zenchent, Necon 10/11, and Necon 1/35-28 are commonly used in the prevention of pregnancy. This recall alert only applies to the select lots of birth control pills. No other hormone contraceptive products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=63509&w=10312012&lang=eng
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Increased risk of suicidal thoughts and behaviour
The FDA today notified healthcare professionals that a range of anti-epileptic products, including { drug_name }, were associated with a significantly higher risk of suicidal thoughts and behavior (0.43% vs 0.23%) than placebo in clinical trials. This increased risk was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. These results were consistent amongst the eleven drugs studied, and the FDA believes that this risk is likely to be shared by all antiepileptic medications. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm
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Date Published Title Drug Source
2012-12-02 Watson Laboratories Recalls Several Lots of Birth Control Pills: Zovia, Lutera, Zenchent, and Necon Zovia FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Zonisamide FDA
2008-12-17 New FDA Warning on Seizure Medications Zonisamide FDA
2009-02-24 New Safety Warning for Zonisamide/Zonegran Zonisamide FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Zonisamide FDA
2010-07-21 Zolpidem: Two Lots Recalled Because of Oversized Tablets Zolpidem FDA
2011-04-25 Teva Pharmaceuticals Recalls Single Lot of Zolpidem Tartrate tablets Zolpidem FDA
2012-12-02 Aurobindo Pharma Recalls Single Lot of Northstar Zolpidem Tablets 10 mg Zolpidem FDA
2013-01-10 FDA Lowers Recommended Dose of Sedative Zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) Zolpidem FDA
2007-10-01 Early communication of ongoing safety review Zoledronic Acid FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Zoledronic Acid FDA
2011-09-01 FDA Adds Warning of Risk of Kidney Failure With Use of Reclast (Zoledronic Acid) Zoledronic Acid FDA
2008-08-14 Weight gain associated with use of antipsychotics Ziprasidone MediGuard CRT
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Ziprasidone MediGuard CRT
2014-12-11 FDA Warns Ziprasidone (Geodon) May Cause Rare but Serious Skin Reactions Ziprasidone FDA
2009-06-16 Warnings on Three Zicam Intranasal Zinc Products Zinc FDA
2011-10-18 Study Links Vitamins to Increased Risk Of Death In Older Women Zinc MediGuard CRT
2009-01-14 Update on FDA Safety Review Zileuton FDA
2009-06-12 Updated Safety Information from FDA Safety Review Zileuton FDA
2009-08-28 Updated Prescribing Information Available Zileuton FDA
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