Safety Alerts & Recalls

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Sandoz Inc. Recalls Single Lot of Fluoxetine Capsules 10 mg
Sandoz Inc. has recalled a single lot of Fluoxetine Capsules 10 mg. Lot number BR7539 has been recalled because the gelatin capsules used to make the capsules may be contaminated with bacteria. Fluoxetine is used in the treatment of depression. Fluoxetine is also sold under the brand name Prozac. No other lots, strengths, or brands of Fluoxetine were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm289254.htm
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Pfizer Announces Voluntary Nationwide Recall Of Lo/Ovral-28 And Norgestrel/Ethinyl Estradiol Tablets Due To Tablet Mix-Up
Pfizer Inc. is recalling 1 million packets of birth control pills after uncovering a packaging error that could leave women with too low of a dose of the hormones and raise the risk that they will get pregnant accidentally. The problem affects the following 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets, both manufactured by Pfizer and marketed in the U.S. by Akrimax Rx Products: LO/OVRAL 28 Tablets: E15678, E15679, E15686, E15687, E15690, E15698, E15700, E80434, E80438, F36908, F36909, F43915, F43926, and F43927 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg Tablets: E15677, E15704, E15706, E80440, F16388, F16390, F22132, F31330, F36911, F36913, F43924, F43925, F43934, and F53238 Pfizer found that some packets of the drugs had too many active tablets, while others had too few. These oral birth control products use a series of 21 drug tablets and 7 inactive sugar tablets to regulate the menstrual period while providing contraception. Correct dosing of this product is important in avoiding an unplanned pregnancy. As a result of this packaging error, the daily dose for these oral contraceptives may be incorrect and could leave women without adequate contraception, and place them at risk for unintended pregnancy. This recall only involves Lo/Ovral-28 tablets and generic Norgestrel and Ethinyl Estradiol tablets manufactured by Pfizer and marketed in the U.S. by Akrimax Rx Products. No other brands of Norgestrel and Ethinyl Estradiol tablets are involved in this recall. For more information, please visit: http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp#guid=20120131007121en&source=RSS_2011&page=1 and http://www.fda.gov/Safety/Recalls/ucm289770.htm?source=govdelivery
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Date Published Title Drug Source
2012-02-02 Sandoz Inc. Recalls Single Lot of Fluoxetine Capsules 10 mg Fluoxetine FDA
2012-02-01 Pfizer Announces Voluntary Nationwide Recall Of Lo/Ovral-28 And Norgestrel/Ethinyl Estradiol Tablets Due To Tablet Mix-Up Ethinyl Estradiol with Norgestrel Manufacturer
2012-01-30 Treanda (bendamustine HCL) Recall - Particles Found in Vial Bendamustine FDA
2012-01-26 FDA Makes Changes to Risk Evaluation and Mitigation Strategies (REMS) Program for Nplate (Romiplostim) and Promacta (Eltrombopag) Romiplostim FDA
2012-01-24 FDA Announces New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) Associated with Tysabri (Natalizumab) Natalizumab FDA
2012-01-18 Rexall, Inc Issues Allergy Alert and Recall of Single Lot of Calcium 1200mg plus Vitamin D 1000 IU Softgels FDA
2012-01-18 New Study Raises Concerns about Daily Aspirin Use in People Without a History of Heart Disease Aspirin MediGuard CRT
2012-01-16 New Boxed Warning for Progressive Multifocal Leukoencephalopathy (PML) and Contraindication for Adcetris (Brentuximab vedotin) Brentuximab Vedotin FDA
2012-01-13 New Study Study Finds Small Increased Risk of Heart Attack in Patients Treated with Pradaxa Dabigatran MediGuard CRT
2012-01-09 Possible Supply Shortage and Rare Tablet Mix-up For Opioid Pain Medications from Endo Pharmaceuticals Acetaminophen with Oxycodone FDA
2012-01-09 Novartis Provides Important Information about Tekturna and Aliskiren-Based Products Aliskiren Manufacturer
2012-01-09 Novartis Consumer Health Inc. Issues Voluntary Recall Of Certain Excedrin, Bufferin, and Gas-X Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps FDA
2012-01-04 Teva Pharmaceuticals USA Recalls Single Lot of Hydralazine Hydrochloride Tablets, USP, 25 mg Hydralazine FDA
2012-01-04 Alkem Laboratories Recalls Several Lots of Metformin Hydrochloride, Tablets USP, 850 mg and 1000 mg Metformin FDA
2012-01-04 Mylan Pharmaceuticals Inc. Recalls Single Lot of Verapamil HCI Extended-Release Capsules, 180 mg Verapamil FDA
2012-01-04 Biovail Corp. Recalls Single Lot of Wellbutrin XL 150 mg Bupropion FDA
2012-01-02 FDA Approves Risk Management Plan for Entire Class of Transmucosal Immediate-Release Fentanyl (TIRF) Medicines Fentanyl FDA
2011-12-29 FDA Alerts Pharmacists and Health Care Professionals to Potential for Mix-up when Dispensing the Drugs Durezol and Durasal Salicylic Acid FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available Acetaminophen FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available FDA