Safety Alerts & Recalls

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Additional List of Recalled Lots of Daytrana Patches Published By FDA
This week's FDA Enforcement Report published additional lot numbers associated with the December 2009 recall of Daytrana Pataches from Shire Pharmaceuticals. These lots are being recalled because some Daytrana patches may not meet their release liner removal specification. As a result, patients and caregivers could have difficulty removing the liners from the patches. The complete list of lot numbers in the recall include: 1) Daytrana 10 mg - Lots 33985, 34167, 2994211, 3014711, and 3014811 2) Daytrana 15 mg - Lots 33986, 34168, 38127, and 38697 3) Daytrana 20 mg - Lots 33988, 33989, 34173, 34174, 34175, 37611, 37686, 37743, 38126, 38700, 39098, and 2819711 4) Daytrana 30 mg - Lots 33040, 33047, 33209, 33210, 33990, 33991, 33993, 33995, 34178, 34179, 34191, 37788, and 3073611 Daytrana is a patch form of methylphenidate used to treat attention deficit hyperactivity disorder (ADHD). Methylphenidate is also sold under the other names Concerta, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, and Ritalin-SR. This recall does not affect these other products. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm214953.htm To view the iGuard Safety Alert about the December 2009 recall, please visit: https://www.iguard.org/alerts/alert/881.html
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King Pharmaceuticals Inc, and Actavis Elizabeth LLC Recall Several Lots of Embeda
King Pharmaceuticals Inc, and Actavis Elizabeth LLC are recalling select lots of Embeda (morphine sulfate and naltrexone hydrochloride) capsules. The following lot numbers are being recalled because samples from these lots failed the routine manufacturer tests that measure the capsules ability to dissolve: 1) Embeda 20 mg/0.8 mg Extended Release Capsules - Lots 581H91, 158G91 and 582H91 2) Embeda 30 mg/1.2 mg Extended Release Capsules - Lots 159G91 and 585H91 3) Embeda 60 mg/2.4 mg Extended Release Capsules - Lots 616H91, 503H91 and 617H91, Exp. 4) Embeda 50 mg/2.0 mg Extended Release Capsules - Lots 160G91, 586H91 and 587H91 5) Embeda 80 mg/3.2 mg Extended Release Capsules - Lot 583H91 6) Embeda 100 mg/4 mg Extended Release Capsules - Lot 588H91 Embeda is used in the treatment of chronic pain and contains the ingredients morphine and naltrexone. This recall alert only applies to these select lots of Embeda. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm214953.htm
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Date Published Title Drug Source
2010-06-11 Additional List of Recalled Lots of Daytrana Patches Published By FDA Methylphenidate FDA
2010-06-11 King Pharmaceuticals Inc, and Actavis Elizabeth LLC Recall Several Lots of Embeda Morphine and Naltrexone FDA
2010-06-11 UCB Manufacturing, Inc and DSM Pharmaceuticals, Inc Recall Two Lots of Semprex-D Capsules Acrivastine and Pseudoephedrine FDA
2010-06-14 Angiotensin-Receptor Blockers (ARBs) May Be Linked to Small Increased Risk of Cancer Telmisartan MediGuard CRT
2010-06-15 FDA Warns Consumers About Correct Vitamin D Supplementation for Infants Ergocalciferol FDA
2010-06-16 McNeil Expands Recall To Include Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels Diphenhydramine Manufacturer
2010-06-18 FDA Warns That Generic Tamiflu From Internet Is Fake and Could Be Harmful Oseltamivir FDA
2010-06-18 Long-term Use of Isotretinoin Linked to Increased Risk of Ulcerative Colitis Isotretinoin MediGuard CRT
2010-06-22 FDA: Pfizer Voluntarily Withdraws Mylotarg (gemtuzumab ozogamicin) From U.S. Market FDA
2010-06-25 P&G Recall: 4-Hour Nasal Decongestant Spray by Sinex Sold in U.S. Stores Oxymetazoline Manufacturer
2010-06-29 Two New Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems: FDA Safety Review Ongoing Glimepiride and Rosiglitazone MediGuard CRT
2010-07-06 Bristol-Myers Recalls Coumadin Blister Pack Samples Warfarin Manufacturer
2010-07-09 FDA Warns Using Malaria Medication for Leg Cramps Can Lead to Serious Side Effects Quinine Sulfate FDA
2010-07-09 McNeil Expands Recall To Include Additional Lots of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB, Tylenol Extra Strength, and Tylenol PM Ibuprofen Manufacturer
2010-07-11 McNeil Expands Recall To Include Additional Lots of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB, Tylenol Extra Strength, and Tylenol PM Acetaminophen with Diphenhydramine Hydrochloride Manufacturer
2010-07-13 Leflunomide (Arava): FDA Adds Information on Severe Liver Injury to the Boxed Warning Leflunomide FDA
2010-07-16 FDA Announces Ongoing Safety Review of Angiotensin Receptor Blockers (ARBs) for Cancer Risk Telmisartan FDA
2010-07-16 Stolen Advair Inhalers Appear in Pharmacies Fluticasone Propionate with Salmeterol FDA
2010-07-20 Quixin: Recall of Two Lots Levofloxacin FDA
2010-07-20 Lorazepam 0.5 mg Tablets: Sandoz Recalls Single Lot Lorazepam FDA