Safety Alerts & Recalls

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Physicians Total Care, Inc Recalls Several Lots of Morphine Sulfate Extended Release and Immediate Release tablet, 30 mg
Physicians Total Care, Inc has recalled several lots of Morphine Sulfate Extended Release and Immediate Release tablets, 30 mg. The following lot numbers have been recalled because the labels have been mixed up and batches of Morphine Sulfate Extended released may have Morphine Sulfate Immediate released tablets and vice-versa: Morphine Sulfate Extended Release tablet, 30 mg, bottles of 60 tablets: Batch number 65IT Morphine Sulfate Immediate Release tablet, 30 mg, bottles of 120 tablets: Batch number 65J2 Morphine Sulfate is used in the treatment of pain. Morphine Sulfate is also sold under other brand names. No other lots, strengths, or brands of Morphine Sulfate 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=61233&w=06272012
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FDA Consumer Update: How Long Should You Take Osteoporosis Drugs?
The Food and Drug Administration (FDA) has published a Consumer Update based on an article published in the May 31, 2012 issue of The New England Journal of Medicine that reviews the benefits of osteoporosis drugs and discusses how long patients should take them. Researchers at the FDA have taken a close look at the long-term benefit of bisphosphonates, a class of medications widely prescribed to treat osteoporosis and determined that some patients may be able to stop using bisphosphonates after three to five years and still continue to benefit from their use. Bisphosphonates used for osteoporosis are known by generic and brand names such as alendronate (Fosamax, Fosamax Plus D), ibandronate (Boniva), risedronate (Actonel, Actonel with Calcium, Atelvia), and zoledronic acid (Reclast). According to the FDA review, further investigation is needed on the long-term risks and benefits of these drugs. However, the current FDA review of available studies suggests that patients at low risk of fracture (for example, younger patients without a fracture history and with a bone mineral density approaching normal) may be good candidates for stopping bisphosphonate therapy after three to five years. In contrast, patients at increased risk for fractures (for example, older patients with a history of fracture and a bone mineral density remaining in the osteoporotic range) may benefit further from continued bisphosphonate therapy. This FDA review looked specifically at the risks of long-term use of bisphosphonates in osteopenia and osteoporosis. This review did not address the long-term use of bisphosphonates in other conditions. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm309688.htm?source=govdelivery
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Date Published Title Drug Source
2012-07-05 Physicians Total Care, Inc Recalls Several Lots of Morphine Sulfate Extended Release and Immediate Release tablet, 30 mg Morphine FDA
2012-06-29 FDA Consumer Update: How Long Should You Take Osteoporosis Drugs? Ibandronate Sodium FDA
2012-06-26 FDA Warns Cefepime Needs Dosage Reduced in Patients with Poor Kidney Function Cefepime FDA
2012-06-07 Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw Levonorgestrel with Ethinylestradiol FDA
2012-05-31 Merck Inc. Recalls Several Lots of Celestone brand of Betamethasone Oral Solution, 0.6 mg/ 5 mL Betamethasone FDA
2012-05-31 FDA Warns: Benzocaine and Babies Are Not a Good Mix Benzocaine FDA
2012-05-30 FDA Warns Consumers About Counterfeit Version of Teva’s Adderall Amphetamine Salts FDA
2012-05-24 Franck’s Pharmacy Recalls All Sterile Human and Veterinary Compounded Prescriptions Distributed Between November 21, 2011 to May 21, 2012 FDA
2012-05-23 McNeil Consumer Healthcare Recalls Imodium Manufacturer
2012-05-22 FDA's New Pediatric Prescribing Information Database is a Resource for Parents and Caregivers FDA
2012-05-21 Lupin Pharmaceuticals Inc. Recalls Single Lots of Levonorgestrel and Ethinyl Estradiol Tablets (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets (0.01 mg) Levonorgestrel with Ethinylestradiol FDA
2012-05-21 Warner Chilcott Company LLC Recalls Several Lots of Ovcon 50 Norethindrone with Ethinyl Estradiol FDA
2012-05-21 Sunovion Pharmaceuticals Recalls a Single Lot of Omnaris (ciclesonide) Nasal Spray 50 mcg Ciclesonide Nasal FDA
2012-05-21 Pfizer Recalls Advil Liqui-Gel Bottles Because of Odor Concern Ibuprofen FDA
2012-05-17 FDA Issues Statement About Latest Study Regarding Azithromycin (Zithromax) and Rare Risk of Heart Related Death Azithromycin FDA
2012-05-15 Paddock Laboratories, Inc. Recalls Several Lots of Lorazepam Oral Concentrate, 2 mg/mL Lorazepam FDA
2012-05-15 Forest Pharmaceuticals Inc. Recalls Several Lots of Campral (acamprosate calcium) Delayed-Release Tablets, 333 mg Acamprosate FDA
2012-05-15 Actavis South Atlantic LLC Recalls Several Lots of Bupropion Hydrochloride Extended-Release Tablets (XL), 150 mg and 300 mg Bupropion FDA
2012-05-15 Teva Pharmaceuticals USA, Inc Recalls Several Lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg Tetracycline FDA
2012-05-15 Medtech Products, Inc. Recalls Several Lots of Little Fevers Children's Fever/Pain Reliever (acetaminophen) liquid, 160 mg/ 5 mL Acetaminophen FDA