Safety Alerts & Recalls

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FDA Completes Safety Review of Drospirenone-Containing Birth Control Pills - Yaz (generics – Gianvi and Loryna), Yasmin (generics – Ocella, Syeda, and Zarah), Beyaz, and Safyral
The Food and Drug Administration (FDA) has completed its review of recent observational studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, the FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Drospirenone is found in the following birth control pills: Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah. It is also available under the generic name Drospirenone and Ethinyl Estradiol. The FDA is adding information about the studies to the prescribing information of drospirenone-containing birth control pills. The revised prescribing information will report that while some studies found no increased risk, others reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to birth control products containing other progestins. For more information, please visit: www.fda.gov/Drugs/DrugSafety/ucm299305.htm
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FDA Warns about Counterfeit Altuzan (bevacizumab), a Cancer Medicine
The Food and Drug Administration (FDA) lab tests have confirmed that a counterfeit version of Roche’s cancer therapy Altuzan 400mg/16ml (bevacizumab), was found in the U.S. and does not contains the active ingredient bevacizumab. Please note that Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey). The FDA reports that medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI). In the U.S. bevacizumab is approved by the FDA under the brand name Avastin and is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials nor does it list the name Altuzan. Bevacizumab belongs to a class of cancer therapies that interferes with the development of new blood vessels that tumors need to grow. The drug, often used with chemotherapy, is for certain patients with colon, lung and other cancers. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298583.htm?source=govdelivery
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Date Published Title Drug Source
2012-04-11 FDA Completes Safety Review of Drospirenone-Containing Birth Control Pills - Yaz (generics – Gianvi and Loryna), Yasmin (generics – Ocella, Syeda, and Zarah), Beyaz, and Safyral Drospirenone with Ethinyl Estradiol FDA
2012-04-04 FDA Warns about Counterfeit Altuzan (bevacizumab), a Cancer Medicine Bevacizumab FDA
2012-04-01 Sandoz Inc Recalls Select Lots of Enoxaparin Sodium Injection, 100 mg/mL and 30 mg/mL Lovenox FDA
2012-03-28 FDA Revises Recommendations for Citalopram (Celexa) Related to a Potential Risk of Abnormal Heart Rhythms Citalopram FDA
2012-03-27 Procter & Gamble Co. Recalls Several Lots of Pepto Bismol Original, Cherry Flavor, and Max Strength Bismuth FDA
2012-03-27 Mylan Technologies, Inc. Recalls Single Lot of Clonidine Transdermal System, 0.2 mg/day Clonidine FDA
2012-03-27 Sandoz, Inc. Recalls Single Lot of Midodrine Tablets, 5mg Midodrine Hydrochloride FDA
2012-03-27 Golden State Medical Supply Inc. Recalls Several Lots of Ropinirole 0.25 mg, 0.5 mg, 1 mg and 2 mg tablets Ropinirole FDA
2012-03-19 Noven Pharmaceuticals, Inc Recalls Several Lots of Daytrana (methylphenidate) Patch, 20 mg and 30 mg Methylphenidate FDA
2012-03-19 Hi-Tech Pharmacal Co. Recalls Single Lot of Valproic Acid Oral Solution 250 mg/5 mL Divalproex Sodium FDA
2012-03-19 Johnson & Johnson Recalls Single Lot of Aveeno Baby Calming Comfort Lotion FDA
2012-03-19 Teva Pharmaceuticals Recalls Single Lot of Flutamide Capsules 125 mg Flutamide FDA
2012-03-19 Bausch & Lomb Recalls Single Lot of Brimonidine Tartrate Ophthalmic Solution 0.2% Brimonidine FDA
2012-03-08 FDA Warns that Skin Lightening and Anti-Aging Products Found to Contain Mercury Royal Jelly FDA
2012-03-07 Sun Pharmaceutical Industries Recalls Several Lots of Azelastine Hydrochloride Ophthalmic Solution, 0.05% Azelastine FDA
2012-03-07 GlaxoSmithKline Inc. Recalls Several Lots of Ventolin HFA (Albuterol Sulfate) 90 mcg Albuterol FDA
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
2012-03-05 New Jersey CVS Pharmacy Dispenses Breast Cancer Medicine Instead of Kids' Fluoride Tablets Sodium Fluoride MediGuard CRT
2012-03-02 FDA Warns about Drug Interaction - Taking Both Statins and HIV or Hepatitis C Drugs Increases Risk of Muscle Injury Indinavir FDA
2012-02-29 Prevnar Vaccine Recall Unlikely to Pose Health Risk Pneumococcal Conjugate Vaccine FDA