Safety Alerts & Recalls

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Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw
Sandoz has issued a voluntary recall of 10 lots of its generic birth control pill Introvale. These lots of Introvale have been recalled because of a recent report of a packaging flaw. A consumer reported that the white placebo tablets (also sometimes called "sugar pills") were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th row, the final row in the pack labeled “Week 13”. Each three-month blister card of Introvale contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, there is a risk of an unintended pregnancy if a patient takes the wrong tablet over several days due to the incorrect packaging. The lot numbers involved in the recall are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012. At this time, Sandoz is not aware of any reports of related adverse events. Introvale is an extended-cycle oral contraceptive containing the hormones levonorgestrel and ethinyl estradiol. No other birth control products containing levonorgestrel and ethinyl estradiol are involved in this recall. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm307103.htm?source=govdelivery
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Merck Inc. Recalls Several Lots of Celestone brand of Betamethasone Oral Solution, 0.6 mg/ 5 mL
Merck Inc. is recalling several lots of Celestone brand of Betamethasone Oral Solution, 0.6 mg/ 5 mL. The following lots are being recalled because tests on the bottles in these lots found variation in the concentration of the solution: LOT 9 APR 100 LOT 9 APR 101 LOT 9 APR 102 LOT 9 APR 103 LOT 0 APR 100 LOT 0 APR 101 LOT 0 APR 102 LOT 0 APR 103 Celestone contains the active ingredient betamethasone and is used in the treatment of various conditions such as allergies, skin conditions, and breathing disorders. This recall alert only applies to the select lots of Celestone brand of Betamethasone Oral Solution, 0.6 mg/ 5 mL. No other betamethasone products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm305469.htm
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Date Published Title Drug Source
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
2012-05-14 FDA Revises Recommendations for Heart Monitoring and Use of Multiple Sclerosis Drug Gilenya (Fingolimod) Fingolimod FDA
2012-05-11 FDA Reviews Long-Term Use of Bisphosphonate Bone Drugs Ibandronate Sodium MediGuard CRT
2012-05-11 FDA Warns on Dangers of Unproven Treatment for Multiple Sclerosis Interferon Beta-1A FDA