NRAC Issue #1667 ADDENDUM January 29, 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 NuCel Labs Eye Drops and Eye/War Wash in 1/4 oz plastic bottles RECALL NUMBER Not available at the time of this publication CODE No lot numbers or expiration dates. Eye drops are labeled "Eye Drops Caution: Do Not Use With Implants" Wash is labeled "Eye/Ear Wash." MANUFACTURED & RECALLED BY NelCel Labs, Idaho Falls, ID QUANTITY 500 units DISTRIBUTION Nationwide REASON There is bacteria and particulate matter in the products, deeming them non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. CONTACT NuCel Labs 1-208-542-0325 -------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03 RECALL NUMBER # Z-0258-2008 CODE All instruments manufactured till 03/21/07 MANUFACTURED & RECALLED BY Intuitive Surgical, Inc., Sunnyvale, CA QUANTITY 1,136 units DISTRIBUTION Nationwide and Internationally REASON Mislabeling electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application) --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs) RECALL NUMBER # Z-0127-2008 CODE Lot Numbers: 49535M100 and 55451M200 MANUFACTURED & RECALLED BY Abbott Laboratories, Abbott Park, IL QUANTITY 1,722 packs DISTRIBUTION Nationwide REASON Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1 RECALL NUMBER # Z-0120-2008 CODE Lot Number/ Exp. Date: A7003, 01/2009; A7002, 11/2008; A7001, 10/2008; A6005, 04/2008; A6004, 01/2008 MANUFACTURED & RECALLED BY AmniSure International LLC, Cambridge, MA QUANTITY 170,000 kits DISTRIBUTION Nationwide and Internationally REASON Weak true positive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect" --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT SoftBank II version 23.1, 23.1.1.x, 23.1.2.x With Softscape 1.2.0.x RECALL NUMBER # B-0505-08 CODE Version 23.1, 23.1.1.x, 23.1.2.x with Softscape 1.2.0.x MANUFACTURED & RECALLED BY SCC Soft Computer, Clearwater, FL QUANTITY 100 units DISTRIBUTION Nationwide and Canada REASON Software, with a glitch or defect, was distributed. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Budeprion SR (Bupropion HCl) Extended-Release Tablets, 150 mg, 100-tablet bottles, Rx only, NDC 0093-5502-01 RECALL NUMBER # D-086-2008 CODE Lots: 7050091, 7050101, 7050961, 7050971, 7050981, 7050991, 7051001, 7051011, 7051021, 7051031, 7051041, 7051051, 7051061, 7051071, 7051081, 7051091; expiry 5/2009 for all lots MANUFACTURER Impax Laboratories Inc, Hayward, CA RECALLED BY Teva Pharmaceuticals USA, North Wales, PA QUANTITY 187,455/100-tablet bottles DISTRIBUTION Nationwide REASON Product does not meet time-release dissolution specifications. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Lithium Carbonate Extended Release Tablets, USP, 450 mg, 90 And 100 count bottles, Rx only, NDC 0143-1277-01 RECALL NUMBER # D-085-2008 CODE 100 count bottle; Lot number 62395C, Exp. Date 3/2008 90 count bottle; Lot number 62395B, Exp. Date 3/2008 MANUFACTURED & RECALLED BY West-Ward Pharmaceutical Corp, Eatontown, NJ QUANTITY 156 bottles of 100 count DISTRIBUTION Nationwide and PR REASON Failed USP Dissolution Specification; 18 month stability. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Children's Dimetapp Cold & Chest Congestion Syrup, active ingredients (in each 5 mL tsp): Phenylephrine HCl 5 mg and Guaifenesin 100 mg, 4 fl. oz. bottles, OTC RECALL NUMBER # D-087-200; PRODUCT b) Robitussin Cough & Cold CF Syrup, active ingredients (in each 5 mL tsp): Dextromethorphan HBr 10 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg; 4 fl. oz., 8 fl. oz. and 12 fl. oz. bottles, OTC RECALL NUMBER # D-088-2008 PRODUCT c) Robitussin Chest Congestion Guaifenesin Syrup, active ingredient (in each 5 mL tsp): Guaifenesin 100 mg; 4 fl. oz. and 8 fl. oz. bottles, OTC RECALL NUMBER # D-089-2008 PRODUCT d) Robitussin Cough & Congestion Syrup, active ingredients (in each 5 mL tsp): Dextromethorphan HBr 10 mg and Guaifenesin 200 mg; 4 fl. oz. and 8 fl. oz. bottles, OTC RECALL NUMBER # D-090-2008 PRODUCT e) Robitussin Cough DM Syrup, active ingredients (in each 5 mL tsp): Dextromethorphan HBr 10 mg and Guaifenesin 100 mg; 4 fl. oz., 8 fl. oz, and 12 fl. oz. bottles, OTC RECALL NUMBER # D-091-2008 PRODUCT f) Robitussin-CF Syrup, active ingredients (in each 5 mL tsp): Dextromethorphan HBr 10 mg; Guaifenesin 100 mg, Pseudoephedrine HCl 30 mg; 4 fl. oz., 8 fl. oz., and 12 fl. oz. bottles, OTC RECALL NUMBER # D-092-2008 PRODUCT g) Robitussin PE Syrup, active ingredients (in each 5 mL tsp): Pseudoephedrine HCl 30 mg and Guaifenesin 100 mg; 4 fl. oz. and 8 fl. oz. bottles, OTC RECALL NUMBER # D-093-2008 PRODUCT h) Robitussin Head & Chest Congestion PE Syrup, active ingredients (in each 5 mL tsp): Phenylephrine HCl 5mg and Guaifenesin 100 mg; 4 fl. oz. bottles, OTC RECALL NUMBER # D-094-2008 PRODUCT i) Robitussin Sugar Free Cough Syrup, active ingredients (in each 5 mL tsp): Dextromethorphan HBr 10 mg and Guaifenesin 100 mg; 4 fl. oz. bottles, OTC RECALL NUMBER # D-095-2008 CODE a) All lots with expiration date May 2009 b) All lots with expiration dates January 2008 to August 2009 c) All lots with expiration dates October 2007 to August 2010 d) All lots with expiration dates May 2008 to August 2010 e) All lots with expiration dates October 2007 to August 2010 f) and g) All lots within expiration h) All lots with expiration dates January 2008 to April 2009 i) All lots with expiration dates October 2007 to February 2010 MANUFACTURED & RECALLED BY Richmond Division of Wyeth, Richmond, VA QUANTITY 1,822,132 bottles/month DISTRIBUTION Nationwide REASON Dosing cups packaged with the product lack the 1/2 teaspoon mark for dosing children 2 to 6 yrs of age. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Perphenazine Tablets, USP, 8 mg, 100 and 500 tablets, Rx only, NDC 0603-5092-21 and NDC 0603-5092-28, NDC 54738-552-01 RECALL NUMBER # D-083-2008 PRODUCT b) Perphenazine Tablets, USP, 16 mg, 100 tablets, Rx only, NDC 0603-5093-21 and NDC 54738-553-01 RECALL NUMBER # D-084-2008 CODE a) 100 count: T019G07D, exp 07/09 and T019G07C, exp 07/09 500 count: T019G07B, exp 07/09 and T019G07A, exp 07/09 b) 100 count: T049F07A, exp 06/09; T020G07B, exp 07/09; and, T020G07A, exp 07/09 MANUFACTURED & RECALLED BY Vintage Pharmaceuticals LLC, Huntsville, AL QUANTITY 20,402 units DISTRIBUTION Nationwide REASON Tablet separation; cracking and splitting of tablets. ---------------------------------------------------------------------------