RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I ___________________________________ PRODUCT a) APS Heparin Sodium Injection 10MU/mL (10000u/mL), 1ml SDV 25UD (bag), Recall # D-273-2008; b) APS Heparin Sodium Injection SDV 10MU/mL (10,000 units/mL), 25UD (box & rod), Recall # D-274-2008 CODE a) Lot #074155 Exp Date; 8/31/09; Lot #073712 Exp Date 2/31/08; Lot #073613 Exp Date 12/31/08; Lot #073454 Exp Date 12/31/08; Lot #073391 Exp Date 12/31/08; Lot #073089 Exp Date 10/31/08; Lot #072907 Exp Date 10/31/08; Lot #070095D Exp Date 5/31/08; Lot #070095A Exp Date 5/31/08; b) Lot #070095B Exp Date 5/31/08; Lot #070095C Exp Date 5/31/08; Lot #068286 Exp Date 4/3008; Lot #067755 Exp Date 4/30/08 RECALLING FIRM/MANUFACTURER Recalling Firm: American Health Packaging, Columbus, OH, by e-mail and letter on March 3, 2008. Manufacturer: Baxter Healthcare, Corp., Round Lake, IL. Firm initiated recall is ongoing. REASON Presence of Foreign Substance; over-sulfated chondroitin sulfate (Baxter). VOLUME OF PRODUCT IN COMMERCE 1,421 units of 25 unit dose vials each DISTRIBUTION GA, CA ___________________________________ PRODUCT Heparin Sodium, USP (Porcine Intestines), Caution: For Manufacturing and Processing use only. Federal Law Prohibits dispensing without a Prescription. Preserve in tight containers and store below 40 degrees C. Preferably at room temperature. Activity = mmu (1,000,000 USP units of heparin activity), Recall # D-278-2008 CODE 1035-0814, 1035-0815, 1035-0816, 1035-0817, 1035-0818, 1060-07-0016, 1060-07-0017, 1060-07-0018, 1060-07-0020, 1060-07-0021, 1060-07-0022, 1060-07-0023, 1060-07-0024, 1060-07-0025, 1060-07-0026, 1060-07-0027, 1060-07-0028, 1060-07-0029, 1060-07-0030, 1060-07-0031, 1060-07-0034, 1060-07-0035, 1060-07-0036, 1060-07-0037, 1060-07-0038, 1060-07-0039, 1060-07-0040, 1060-07-0041, 1060-07-0042, 1060-07-0043, 1060-07-0044, 1060-07-0045, 1060-07-0046, 1060-07-0047, 1060-07-0048, 1060-07-0049, 1060-07-0050 EXPANDED: 1035-0772, 1035-0773 RECALLING FIRM/MANUFACTURER Recalling Firm: Scientific Protein Laboratories, LLC, Waunakee, WI, by telephone and letter on March 6, 2008 and by telephone on March 14, 2008, e-mail on March 18, 2008 and by letter beginning March 20, 2008. Manufacturer: Changzhou SPL Company, Ltd., Changzhou, China. Firm initiated recall is ongoing. REASON Presence of foreign substance; identification of unexpected, additional signals and peaks. Now identified as over-sulfated chondroitin sulfate. VOLUME OF PRODUCT IN COMMERCE 1035 ~350kg (60,884 mmu), 1036 ~2240kg (386,391 mmu) EXPANDED 1035: 23,002.72 mmu DISTRIBUTION NJ, CA, IL, NJ, NY, PA, Canada, Ireland RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II ___________________________________ PRODUCT Mommy?s Bliss Nipple Cream, 2 fl. Oz. tubes, Recall # D-261-2008 CODE All products with lot codes/expiration dates 1388/05/2009, 1419/05/2009, and 1478/07/2009 RECALLING FIRM/MANUFACTURER Recalling Firm: MOM Enterprises, Inc., San Rafael, CA, by telephone and internet on May 28, 2008. Manufacturer: LifeTech Resources, Chatsworth, CA. Firm initiated recall is ongoing. REASON Unapproved New Drug; product contains chlorphenesin and phenoxyethanol VOLUME OF PRODUCT IN COMMERCE 5,628 units DISTRIBUTION Nationwide ___________________________________ 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 # D-275-2008 CODE Lot 3955 (3955PU on carton), exp. February 1, 2010 RECALLING FIRM/MANUFACTURER Recalling Firm: Lantheus Medical Imaging, Inc., North Billerica, MA, by telephone on June 14, 2008 and by letter on June 17, 2008. Manufacturer: Ben Venue Laboratories, Inc., Bedford, OH. Firm initiated recall is ongoing. REASON Sterility of the product is not assured. VOLUME OF PRODUCT IN COMMERCE 8,460 vials DISTRIBUTION Nationwide and Internationally ___________________________________ PRODUCT a) Heparin Sodium Powder, USP, Bulk, HE150, 1 Million Units, Potency = 173 U/mg CAS 9041-08-1, Recall # D-276-2008; b) Heparin Sodium Powder, USP, Bulk, HE150, 10,000 Units, Potency = 173 U/mg CAS 9041-08-1, Recall # D-277-2008 CODE a) and b) Lot: XB0070 RECALLING FIRM/MANUFACTURER Spectrum Laboratory Products, Inc., Gardena, CA, by telephone on April 2, 2008, and by fax and e-mail on April 18, 2008. Celsus Laboratories, Inc., Cincinnati, OH. Firm initiated recall is complete. REASON Presence of foreign substance; product found to be contaminated with over-sulfated chondroitin sulfate (manufacturer). VOLUME OF PRODUCT IN COMMERCE 6 bottles DISTRIBUTION AZ, GA RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III ___________________________________ PRODUCT a) Sandoz, Estradiol Valerate Injection, USP, 40 mg per mL, 5 mL Multiple Dose Vial, Rx only, Sterile, NDC 0781-3031-75, Recall D-268-2008; b) Sandoz, Estradiol Valerate Injection, USP, 20 mg per mL, 5 mL Multiple Dose Vial, Rx only, Sterile, NDC 00781-3029-75, Recall # D-269-2008; c) Sandoz, Estradiol Valerate Injection, USP, 10 mg per mL, 5 mL Multiple Dose Vial, Rx only, Sterile, NDC 0781-3030-75, Recall # D-270-2008 CODE a) Lot number 130964; b) Lot number 138050; c) Lot number 144500 RECALLING FIRM/MANUFACTURER Recalling Firm: Sandoz, Inc., Princeton, NJ, by letters on May 16, 2008 and June 6, 2008. Manufacturer: Sandoz Canada, Inc., Boucherville, Canada. Firm initiated recall is ongoing. REASON Drug product exceeded the unknown impurity specification during stability testing. VOLUME OF PRODUCT IN COMMERCE 7,088/5mL vials DISTRIBUTION Nationwide ___________________________________ PRODUCT Acetaminophen and Codeine Phosphate Oral Solution USP, Each 5mL (one teaspoonful) contains: Acetaminophen 120 mg and Codeine phosphate 12 mg, in 4 fl oz bottles (NDC 0472-1419-04) and 16 fl oz bottles (NDC 0472-1419-16), Rx Only, Recall # D-279-2008 CODE Lot: Q02055, expiration date 07/2009 RECALLING FIRM/MANUFACTURER Actavis Mid-Atlantic, LLC, Baltimore, MD, by letter on April 30, 2008. Firm initiated recall is ongoing. REASON Degradation; acetaminophen (18 month stability) VOLUME OF PRODUCT IN COMMERCE 41,975 bottles DISTRIBUTION Nationwide Source: FDA Zynchros Pharmacy Services