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Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine
Sanofi Pasteur is voluntarily recalling four lots of H1N1 Pediatric (0.25 mL) Vaccine in Pre-Filled Syringes, intended for young children, ages 6 months to almost three years (35 months). The H1N1 Vaccine is given as two doses, separated by 1 month, to prevent H1N1 influenza (often called "swine flu"). Sanofi Pasteur performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to healthcare providers. Stability testing is a measure of the strength or potency of a vaccine over time. During routine stability testing, Sanofi Pasteur found that doses from four vaccine lots no longer met the manufacturer's specifications for potency. Vaccine doses with the following lot numbers are included in the recall: 0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25): UT023DA UT028DA UT028CB 0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70): UT030CA The four lots of vaccine met all required specifications at the time of release and shipment to distribution centers. The H1N1 vaccine provided in multi-dose vials and the single-dose, 0.5 mL pre-filled syringes for persons 36 months and older continues to meet all specifications. For more information, please visit: http://www.flu.gov/individualfamily/vaccination/syringes_qa.html and http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm195333.htm
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Recall on a Single Lot of Phentermine 37.5 mg Tablets
Vintage Pharmaceuticals is recalling a single lot of Phentermine Hydrochloride 37.5 mg tablets with the product code NDC 0603-5192-21. Lot number T058E09A is being recalled because the manufacturer received a complaint of oversized tablets. The tablets were the thickness of two tablets and contained more active ingredient than is stated on the product label. Phentermine is used for short term treatment of obesity through weight loss. Phentermine is also sold under other names including Adipex-P and Ionamin. No other lots, strengths, or brands of phentermine were involved in this recall. For more information, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm192035.htm
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Date Published Title Drug Source
2009-12-16 Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine Influenza A (H1N1) Vaccine Manufacturer
2009-12-15 Recall on a Single Lot of Phentermine 37.5 mg Tablets Phentermine FDA
2009-12-14 Recall on Two Lots of Motrin IB/Ibuprofen Tablets, 200 mg, 8 count Coated Caplets Ibuprofen FDA
2009-12-14 Recall on Select Lots of Senna-Time and Senna-Time S Tablets FDA
2009-12-14 Incorrect Medication Guides Shipped with Single Lot of Sertraline Sertraline FDA
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Acetaminophen with Pseudoephedrine Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-11 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-11 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-08 Risk of Neural Tube Birth Defects Following Prenatal Exposure to Valproate Sodium, Valproic Acid, or Divalproex Sodium Divalproex Sodium FDA
2009-12-08 Safety Update to the Prescribing Information for Diclofenac Products Diclofenac Sodium with Misoprostol FDA