Medical Alerts

January – February 2014

Date Brand Name Product Description Reason/ Problem Company
02/19/2014 Pfizer   Etomidate Injection, 2mg/mL   1) potential for small black particles, identified as paper shipper labels, to be present in individual vials; 2) Potential for missing lot number and/or expiry date on the outer carton 3) Potential for illegible/missing lot number and expiry on individual vials Agila Specialties Private Limited; Subsidiary of Mylan Inc.
02/14/2014 Ben Venue Laboratories, Inc.   Acetylcysteine Solution 10%, USP,   Glass particulate (visible) Ben Venue Laboratories, Inc.
02/04/2014 Slimeasy, Fruta Bio, Magic Slim, Meizi Evolution and more.   Dietary Supplements   Unapproved new drug MyNicKnaxs, LLC.
01/16/2014 Rohto¨   Eye drops   Manufacturing review at the production facility in Vietnam involving sterility controls The Mentholatum Company
01/13/2014 Pro ArthMax   Dietary Supplement   Undeclared Ingredients Human Science Foundation
01/09/2014 Boost Ultra, XZone Gold & more   Dietary Supplement for sexual enhancement   Unapproved new drug Midwest Wholesale
01/03/2014 Baxter Clinimix   CLINIMIX and CLINIMIX E Injection parenteral nutrition products   Particulate matter Baxter International Inc.
01/02/2014 Burn 7   Dietary Supplement   Unapproved new drug Deseo Rebajar Inc.