Safety Alerts & Recalls

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Keep Eye Drops and Nasal Sprays Out of Kids' Reach
The Food and Drug Administration (FDA) is warning parents to keep over-the-counter (OTC) eye drops used to relieve redness or sprays used to treat nasal congestion out of the reach of children at all times. These products contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline (known as imidazoline derivatives) and are sold under various brand names such as Visine, Dristan and Mucinex, as well as in generic and store brands. Children who accidentally swallow even small amounts of these products can experience serious side effects. Between 1985 and 2012, the FDA has identified 96 cases in which young children (under the age of 5) accidentally swallowed products intended to be applied to the eyes or nose. According to some case reports, children were chewing or sucking on the bottles or were found with an empty bottle next to them. There were no deaths reported, but more than half of the cases (53) reported hospitalization because of symptoms that included nausea, vomiting, lethargy (sleepiness), tachycardia (fast heart beat), and coma. In January, 2012, the U.S. Consumer Product Safety Commission (CPSC) proposed a rule to require child-resistant packaging for all products containing at least 0.08 mg of an imidazoline derivative (tetrahydrozoline, oxymetazoline, or naphazoline). However, this rule has not been finalized. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm325220.htm?source=govdelivery
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FDA Advises Doctors to Contact Patients Who Were Given Any Injectable Medicine Made by NECC after May 21, 2012
The Food and Drug Administration (FDA) continues its investigation of the meningitis outbreak linked to the methylprednisolone steroid injections made by New England Compounding Center (NECC). Most recently, the FDA has received a report of a patient with possible meningitis potentially associated with epidural injection (injection into the spine) of an additional NECC product, triamcinolone acetonide. Triamcinolone acetonide is a type of steroid injectable product made by NECC. To view a full list of products that are being recalled from NECC, please visit: http://www.fda.gov/Safety/Recalls/ucm322979.htm For the latest FDA update about the meningitis outbreak, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm A list of common questions and answers about this update, can be viewed here: http://www.fda.gov/Drugs/DrugSafety/ucm322735.htm
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Date Published Title Drug Source
2012-10-25 Keep Eye Drops and Nasal Sprays Out of Kids' Reach Tetrahydrozoline FDA
2012-10-17 FDA Advises Doctors to Contact Patients Who Were Given Any Injectable Medicine Made by NECC after May 21, 2012 Dorzolamide Hydrochloride with Timolol Maleate FDA
2012-10-11 FDA Update: Budeprion XL 300 mg Not Equivalent to Wellbutrin XL 300 mg Bupropion FDA
2012-10-08 Nephron Pharmaceuticals Corporation Recalls Select Lots of Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Vials Albuterol FDA
2012-10-08 Apotex Corp Recalls Single Lot of Meloxicam Tablets, 15 mg Meloxicam FDA
2012-10-08 Teva Recalls Single Lot of Copaxone (glatiramer acetate injection), 20mg/mL Glatiramer Acetate FDA
2012-10-08 Hill Dermaceuticals Inc Recalls Several Lots of Derma-Smoothe/FS 0.01% Topical Oil (Scalp Oil) and Body Oil FDA
2012-10-07 FDA and CDC: Meningitis Outbreak Linked to Epidural Steroid Injection Methylprednisolone FDA
2012-10-02 Sandoz Inc. Recalls Several Lots of Pramipexole Tablets, 0.125 and 0.25 mg Pramipexole FDA
2012-10-02 Apace KY LLC Recalls Single Lot of Enalapril 5mg Tablets Enalapril FDA
2012-10-01 Patients Will Need to Make the Switch From Suboxone Tablets to Suboxone Sublingual Film Buprenorphine with Naloxone Manufacturer
2012-10-01 FDA Approves REMS Program For Mycophenolate-Containing Medicines to Reduce the Risks for Women Who Can Become Pregnant Mycophenolic Acid FDA
2012-09-25 Watson Laboratories Recalls Oversized Hydrocodone Bitartrate and APAP Tablets, 10 mg/500 mg Hydrocodone with Acetaminophen FDA
2012-09-21 Prometheus Laboratories Inc. Recalls Several Lots of Mercaptopurine Tablets 50 mg Mercaptopurine FDA
2012-09-20 FDA Is Conducting Ongoing Safety Review of Parkinson’s drug Mirapex (pramipexole) and Possible Risk of Heart Failure Pramipexole FDA
2012-09-17 Apotex Inc. Recalls Several Lots of Azelastine HCl Nasal Solution Azelastine FDA
2012-09-17 Galderma Laboratories Recalls Several Lots of Capex Shampoo FDA
2012-09-17 GlaxoSmithKline Recalls Several Lots of Ventolin HFA Inhaler Albuterol FDA
2012-09-17 Natural Essentials Recalls Several Lots of Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06% FDA
2012-09-17 Natural Essentials Recalls Several Lots of Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06% Cetylpyridinium FDA