NRAC Issue #1693 ADDENDUM August 5, 2008 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Sandoz, Estradiol Valerate Injection, USP, 40 mg per mL, 5 mL Multiple Dose Vial, Rx only, Sterile, NDC 0781-3031-75 RECALL NUMBER # D-268-2008 PRODUCT b) Sandoz, Estradiol Valerate Injection, USP, 20 mg per mL, 5 mL Multiple Dose Vial, Rx only, Sterile, NDC 00781-3029-75 RECALL NUMBER # D-269-2008 PRODUCT c) Sandoz, Estradiol Valerate Injection, USP, 10 mg per mL, 5 mL Multiple Dose Vial, Rx only, Sterile, NDC 0781-3030-75 RECALL NUMBER # D-270-2008 CODE a) Lot number 130964 b) Lot number 138050 c) Lot number 144500 MANUFACTURER Sandoz Canada, Inc., Boucherville, Canada RECALLED BY Sandoz, Inc., Princeton, NJ QUANTITY 7,088/5mL vials DISTRIBUTION Nationwide REASON Drug product exceeded the unknown impurity specification during stability testing. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), lyophilized sterile powder in 5 mL vials, cartons of 20 vials, Rx only, for diagnostic use, NDC No. 11994-001-20 RECALL NUMBER # D-275-2008 CODE Lot 3955 (3955PU on carton), exp. February 1, 2010 MANUFACTURER Ben Venue Laboratories, Inc., Bedford, OH RECALLED BY Lantheus Medical Imaging, Inc., North Billerica, MA QUANTITY 8,460 vials DISTRIBUTION Nationwide and Internationally REASON Sterility of the product is not assured. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Mommy's Bliss Nipple Cream, 2 fl. Oz. tubes RECALL NUMBER # D-261-2008 CODE All products with lot codes/expiration dates 1388/05/2009, 1419/05/2009, and 1478/07/2009 MANUFACTURER LifeTech Resources, Chatsworth, CA RECALLED BY MOM Enterprises, Inc., San Rafael, CA QUANTITY 5,628 units DISTRIBUTION Nationwide REASON Unapproved New Drug; product contains chlorphenesin and phenoxyethanol ---------------------------------------------------------------------------