Safety Alerts & Recalls

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Latest Alerts

Qualitest Recalls Several Lots of Hydrocortisone and Acetic Acid Otic Solution
Qualitest Pharmaceuticals has recalled several lots of Hydrocortisone and Acetic Acid Otic Solution, 10 ml bottle. The following lot numbers have been recalled because these lots did not pass the manufacturer's routine tests for impurities and by-products from chemical breakdown over time: L072B11A, L102C11A, L103C11A, L046D11A, L082F11A, L089F11A, L148J11A, L149J11A, L150J11A, and L151J11A. Hydrocortisone and Acetic Acid Otic Solution is used to treat inflammation and infections of ear canal. This recall alert only applies to the select lots of the generic Hydrocortisone and Acetic Acid Otic Solution made by Qualitest Pharmaceuticals. No other Hydrocortisone and Acetic Acid Otic Solution products 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=62496&w=07182012&
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Alaven Pharmaceutical LLC Recalls Several Lots of Prefera OB One Gel Capsules
Alaven Pharmaceutical LLC has recalled several lots of Prefera OB One Gel Capsules. The following lot numbers have been recalled because the product label in these lots did not list several of inactive ingredients: 249814, 249816, 260393, 255345, 000001, 261827, 50004, 50005, 50000, and 000002. Prefera OB One contains the active ingredient multivitamin and minerals and is commonly used as a supplemental vitamin during pregnancy. These multivitamins and minerals are also sold under other brand names. This recall alert only applies to the select lots of Prefera OB One Gel Capsules. No other multivitamin and minerals products 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=61683&w=07252012&
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Date Published Title Drug Source
2012-07-25 Qualitest Recalls Several Lots of Hydrocortisone and Acetic Acid Otic Solution FDA
2012-08-09 Alaven Pharmaceutical LLC Recalls Several Lots of Prefera OB One Gel Capsules Prenatal Vitamins FDA
2012-08-09 Bayer Health Care Recalls Several Lots of Midol Complete Midol FDA
2012-08-09 Vintage Pharmaceuticals Recalls Several Lots of Hydroxyzine Hydrochloride Oral Solutions 10 mg/ 5 mL Hydroxyzine FDA
2012-08-09 Grandpa Brands Co. Recalls Select Lots of Dent's Extra Strength Toothache Gum Benzocaine FDA
2012-08-09 Fougera Pharmaceuticals, Inc. Recalls Single Lot of Erythromycin Topical Solution USP, 2% Erythromycin FDA
2012-08-17 FDA Warns: Codeine May Be Risky for Some Children FDA
2012-08-29 Genzyme Recalls Select Lots of Thymoglobulin Manufacturer
2012-08-31 FDA recommends against use of Revatio in children with pulmonary hypertension Sildenafil FDA
2012-09-05 Sun Pharmaceutical Recalls Select Lots of Nimodipine Capsules Nimodipine FDA
2012-09-12 Qualitest Recalls One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone with Acetaminophen Manufacturer
2012-09-14 FDA Warns OTC Topical Pain Relievers May Cause Burns to Skin Methyl Salicylate FDA
2012-09-17 Medtech Products Inc. Recalls Single Lot of Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops Simethicone FDA
2012-09-17 Apotex Recalls Several Lots of Leflunomide tablets,10 mg and 20 mg Leflunomide FDA
2012-09-17 Natural Essentials Recalls Several Lots of Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06% Cetylpyridinium FDA
2012-09-17 Natural Essentials Recalls Several Lots of Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06% FDA
2012-09-17 GlaxoSmithKline Recalls Several Lots of Ventolin HFA Inhaler Albuterol FDA
2012-09-17 Galderma Laboratories Recalls Several Lots of Capex Shampoo FDA
2012-09-17 Apotex Inc. Recalls Several Lots of Azelastine HCl Nasal Solution Azelastine FDA
2012-09-20 FDA Is Conducting Ongoing Safety Review of Parkinson’s drug Mirapex (pramipexole) and Possible Risk of Heart Failure Pramipexole FDA