Safety Alerts & Recalls

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Prometheus Laboratories Inc. Recalls Several Lots of Mercaptopurine Tablets 50 mg
Prometheus Laboratories Inc. has recalled several lots of Mercaptopurine Tablets, 50 mg. The following lot numbers are being recalled because these lots failed the manufacturer routine tests that measure the tablets' ability to dissolve: 11A003, 11A004, 11A005, 11L071, 11L072, 11B009, and 11L073. Mercaptopurine is used in the treatment of certain type of cancer, Crohn’s disease, ulcerative colitis and many other conditions. This recall alert only applies to the single lot of the generic Mercaptopurine Tablets, USP, 50 mg made by Prometheus Laboratories Inc. No other Mercaptopurine 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=62772&w=08292012&lang=eng
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Watson Laboratories Recalls Oversized Hydrocodone Bitartrate and APAP Tablets, 10 mg/500 mg
Watson Laboratories, Inc. has issued a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, 10 mg/500 mg. A customer complaint was received for tablets that were thicker and a darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A may contain higher than indicated amounts of the ingredients Hydrocodone Bitartrate and/or Acetaminophen. Taking a higher dosage of acetaminophen than intended could potentially cause severe liver damage, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are used for the relief of moderate to severe pain. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm320566.htm
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Date Published Title Drug Source
2012-09-21 Prometheus Laboratories Inc. Recalls Several Lots of Mercaptopurine Tablets 50 mg Mercaptopurine FDA
2012-09-25 Watson Laboratories Recalls Oversized Hydrocodone Bitartrate and APAP Tablets, 10 mg/500 mg Hydrocodone with Acetaminophen FDA
2012-10-01 FDA Approves REMS Program For Mycophenolate-Containing Medicines to Reduce the Risks for Women Who Can Become Pregnant Mycophenolic Acid FDA
2012-10-01 Patients Will Need to Make the Switch From Suboxone Tablets to Suboxone Sublingual Film Buprenorphine with Naloxone Manufacturer
2012-10-02 Apace KY LLC Recalls Single Lot of Enalapril 5mg Tablets Enalapril FDA
2012-10-02 Sandoz Inc. Recalls Several Lots of Pramipexole Tablets, 0.125 and 0.25 mg Pramipexole FDA
2012-10-07 FDA and CDC: Meningitis Outbreak Linked to Epidural Steroid Injection Methylprednisolone FDA
2012-10-08 Hill Dermaceuticals Inc Recalls Several Lots of Derma-Smoothe/FS 0.01% Topical Oil (Scalp Oil) and Body Oil FDA
2012-10-08 Teva Recalls Single Lot of Copaxone (glatiramer acetate injection), 20mg/mL Glatiramer Acetate FDA
2012-10-08 Apotex Corp Recalls Single Lot of Meloxicam Tablets, 15 mg Meloxicam 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
2012-10-11 FDA Update: Budeprion XL 300 mg Not Equivalent to Wellbutrin XL 300 mg Bupropion 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
2012-10-25 Keep Eye Drops and Nasal Sprays Out of Kids' Reach Tetrahydrozoline FDA
2012-10-30 Sandoz Inc. Recalls Several Lots of Children's Cetirizine Chewable Tablets 5 mg Cetirizine FDA
2012-10-30 Paddock Laboratories, Inc. Recalls Single Lot of Moexipril Tablets 7.5mg Moexipril FDA
2012-10-30 Actavis Mid Atlantic LLC Recalls Several Lots of Prometh VC Plain and Prometh with Codeine FDA
2012-10-31 Mylan Pharmaceuticals Recalls Single Lot of Famotidine Tablets, 20 mg Famotidine FDA
2012-11-06 FDA Reports Bleeding Risk With Pradaxa Similar to Warfarin Dabigatran FDA
2012-11-06 Recall: Two Bee Pollen Products Found to Contain Sibutramine, an Unapproved Treatment for Weight Loss BEE Pollen FDA