December 4, 2002 02-48
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_____________________________ PRODUCT Balducci's EST 1916 brand GOLDEN RAISINS, NET WT 11 OZ (312 g), packaged in clear, plastic containers. INGREDIENTS: DRIED RAISINS. Firm on label - BALDUCCI'S, NY, NY. Recall # F-084-3. CODE Barcode # (UPC) 54996 06819. RECALLING FIRM/MANUFACTURER Recalling Firm: Sutton Place Gourmet, Bethesda, MD, by press release on May 2, 2002 and letters on May 3, 2002. Manufacturer: A. L. Bazzinni & Co., Inc., Bronx, NY. Firm initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION NY, MD, VA, DC and CT. _____________________________ PRODUCT Kemps Old Fashioned Chocolate Chip Ice Cream, Net Contents Half Gallon, in paper cartons with rounded corners and lids. Recall # F-085-3. CODE 196-2-2 printed on the rim of the lid of the container. It is preceded by a four digit number (military time). RECALLING FIRM/MANUFACTURER Recalling Firm: Marigold Foods Inc., Minneapolis, MN, by telephone on October 1, 2002. Manufacturer: Marigold Foods Inc., Rochester, MN. Firm initiated recall is ongoing. REASON The product may contain undeclared tree nuts. VOLUME OF PRODUCT IN COMMERCE 6800 half gallons. DISTRIBUTION Nationwide. _____________________________ PRODUCT Peanut and Noodle Snack Mix packaged in plastic bag, approximately 8 oz. The product label states "alauddin sweetmeat ltd." and "chanachur". Recall # F-086-3. CODE None. RECALLING FIRM/MANUFACTURER Recalling Firm: Bengal Seafood Inc., Astoria, NY, by telephone on January 3, 2002. Manufacturer: UNKNOWN (Possibly Bangladesh). State initiated recall is complete. REASON The product contained undeclared peanuts. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION NY.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_____________________________ PRODUCT Campbell's Condensed Cream of Mushroom Soup packed in 10 & 3/4 ounce cans. Recall # F-087-3. CODE The cans are identified with the date code: AUG 2004 08292, and the production code: CU B8EL (plus four numbers - XX:XX representing military time). RECALLING FIRM/MANUFACTURER Recalling Firm: Campbell's Soup Company, Camden, NJ, by press release on October 4, 2002. Manufacturer: Campbell's Soup Supply Company, LLC Napoleon, OH. Firm initiated recall is ongoing. REASON Misbranding - Clam Chowder distributed in cans labeled as Campbell's Mushroom Soup. VOLUME OF PRODUCT IN COMMERCE A total of 26, 933 cases (48 cans per case) were distributed. DISTRIBUTION Nationwide. _____________________________ PRODUCT a) MIESZKO brand Duet GALARETKA W CZEKOLADZIE (Jelly Candy) packed in flexible plastic Packages, net wt. 7.74 oz. (220 g). Recall # F-089-3; b) MIESZKO brand Trio GALARETKA W CZEKOLADZIE (Jelly Candy) packed in flexible plastic packages, net wt. 7.04 oz. (200 g). Recall # F-090-3; c) MIESZKO brand Czekoladowe KLEJNOTY (Chocolate Candy), packed in flexible plastic packages, net wt. 1.0 lb. (450 g). Recall # F-091-3. CODE Duet Candy: all codes on the market at the time of recall initiation including 07 01 2006311; barcode #900353 241325. Trio Candy: all codes on the market at the time of recall initiation including 07 01 72000311; barcode #900353 242421. Klejnoty Candy: all codes on the market at the time of recall initiation including 09 2001 81000412 ; barcode 900353 614709. RECALLING FIRM/MANUFACTURER Recalling Firm: Polonica Inc., Brooklyn, NY, by visit on/about July 9, 2001. Manufacturer: Mieszko ZPC S.A. Racibusz, Poland. State initiated recall is complete. REASON Products contained Ponceau 4R, an unapproved color additive. VOLUME OF PRODUCT IN COMMERCE Duet: 50 cases (15 - 7.74 oz. pkgs. per case); Trio: 50 cases (15 - 7.04 oz. pkgs. per case); Klejnoty: 23 cases (10 - 1 lb. pkgs. per case). DISTRIBUTION NY, NJ, CT and PA. _____________________________ PRODUCT Franczoz brand ORIGINAL RECIPE HOME STYLE DONUTS, CHOCOLATE DONUT, NET WT. 9 OZ. (258 g), packed in a cardboard box. Recall # F-092-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Abe Franczoz Bakery Inc., Brooklyn, NY, by visit on/about August 6, 2001. State initiated recall is complete. REASON The product contained undeclared color FD&C Yellow #5. VOLUME OF PRODUCT IN COMMERCE 60 - 9 oz. Packages. DISTRIBUTION NY.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_____________________________ PRODUCT Potato Chips in 1.5 oz and 5.5oz bags labeled as Lay's Salt and Vinegar Artificially Flavored Potato Chips. Recall # F-088-3. CODE Freshness Date: Oct 29 425124101 5.5oz package (all time stamps). Freshness Date: Oct 29 425124106 5.5oz package with time stamp of 13:30-14:00. Freshness Date: Nov 5 425124108 1.5oz package with time stamp of 13:30-14:00. The code information appears in the upper, right corner on the front of every package. RECALLING FIRM/MANUFACTURER Recalling Firm: Frito Lay, Inc., Plano, TX, by visits beginning September 17, 2002. Manufacturer: Frito-Lay, Inc. Topeka, Kansas Manufacturing Plant Topeka, KS. Firm initiated recall is ongoing. REASON Packages contain California Cool Dill Potato Chips instead of Salt and Vinegar Potato Chips. VOLUME OF PRODUCT IN COMMERCE 500 bags of 1830 affected bags were distributed. DISTRIBUTION KS, NE, MO, OK, IA, AK, IL and TX.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
_____________________________ PRODUCT Lunelle Monthly Contraceptive Injection (medroxyprogesterone acetate 25mg and estradiol cypionate 5mg) Injectable Suspension, Single Use 0.5 mL syringe and physician samples, For Intramuscular Use Only, Rx only. Recall # D-064-3. CODE All lots distributed in 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmacia Corporation, Kalamazoo, MI, by press release on October 10, 2002. Manufacturer: Pharmacia Corporation, Puurs, Belgium. Firm initiated recall is ongoing. REASON Subpotency; the active ingredients. VOLUME OF PRODUCT IN COMMERCE 800,000 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_____________________________ PRODUCT a) Oral Saline Laxative (Monobasic sodium phosphate 2.4g and Dibasic sodium phosphate 0.9g), Eckerd brand, 3 Fl. oz. (90mL) multi-dose container, Lemon Flavor, Sugar Free. Recall # D-057-3; b) Oral Saline Laxative (Monobasic sodium phosphate 2.4g and Dibasic sodium phosphate 0.9g), Family Pharmacy brand, 3 Fl. oz. (90mL) multi-dose container, Lemon Flavor, Sugar Free. Recall # D-058-3. CODE 1263L exp. 9/03, 1267L exp. 9/03 and 1281L exp. 10/03. RECALLING FIRM/MANUFACTURER Unico Holdings, Inc., Lake Worth, FL, by telephone and letter on December 19, 2001. Firm initiated recall is complete. REASON Superpotent; active ingredients Monobasic and Dibasic Sodium Phosphate. VOLUME OF PRODUCT IN COMMERCE Lot 1263L 935/12/3 oz cases, Lot 1267L 432/12/3 oz cases, Lot 1281L 447/12/3 oz cases. DISTRIBUTION Nationwide. _____________________________ PRODUCT Novolin 70/30 InnoLet, 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection (rDNA origin), 100 units/mL, 3mL Prefilled Insulin Syringes, Novo Nordisk. Recall # D-062-3. CODE Lot # MS 60812 Exp. 6/2004 NDC# 0169-2317-21. RECALLING FIRM/MANUFACTURER Recalling Firm: Novo Nordisk Pharmaceuticals, Princeton, NJ, by fax on August 16, 2002. Manufacturer: Novo Nordisk A/S Bagsvaerd, Denmark. Firm initiated recall is ongoing. REASON Defective container; delivery system may dispense less than the expected amount of insulin VOLUME OF PRODUCT IN COMMERCE 83,789 units. DISTRIBUTION Nationwide and Puerto Rico.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_____________________________ PRODUCT YNTEST H.S. (Half Strength Tablets), (Esterified estrogens 0.625mg and Methyltestosterone 1.25mg), 100 Tablet bottles, Rx only. Recall # D-063-3. CODE Lot S02D02, expiration date 3/2004 NDC # 66576-230-01. RECALLING FIRM/MANUFACTURER Syntho Pharmaceuticals, Inc., Farmingdale, NY, by telephone on/about May 7, 2002. Firm initiated recall is complete. REASON Mislabeling; package insert incorrectly indicates dosage strength of Syntest D.S. as 2.5mg of Esterified Estrogens and 5mg Methyltestosterone rather than correctly as 1.25mg Esterified Estrogens and 2.5mg Methyltestosterone. VOLUME OF PRODUCT IN COMMERCE 10,008 bottles (100 tablets per bottle). DISTRIBUTION KY.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_____________________________ PRODUCT Tibialis Tendon Allografts, Recall # B-0215-3. CODE Units 7797174, 7797158. RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA, by letter dated October 9, 2002. Firm initiated recall is complete. REASON Human tissues, collected from a donor who was suspected to have viral encephalitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX. _____________________________ PRODUCT a) Red Blood Cells, Recall # B-0242-3; b) Recovered Plasma, Recall # B-0243-3. CODE a) and b) Unit 42FE60831. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by letter dated May 2, 2002. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Proscar, were distributed VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _____________________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0245-3. b) Recovered Plasma, Recall # B-0246-3. CODE a) and b) Unit 16LM59278. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by letter or fax on July 5, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Methotrexate, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NJ and CA. _____________________________ PRODUCT Platelets, Leukoreduced, Irradiated, Recall # B-0247-3. CODE Units 16GM19154, 16KC21628, 16KC21626. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by letter dated August 26, 2002. Firm initiated recall is complete. REASON Blood products, for which documentation of irradiation was incomplete, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OH.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_____________________________ PRODUCT Platelets, Leukoreduced, Recall # B-0248-3. CODE Unit 42K52117. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by telephone on July 16, 2002 and by letter dated August 1, 2002. Firm initiated recall is complete. REASON Blood product, manufactured from a unit of Whole Blood with a discrepant collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _____________________________ PRODUCT Source Plasma, Recall # B-0250-3. CODE Unit 76179440. RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Columbus, OH, by fax dated July 15, 2002. Firm initiated recall is complete. REASON Blood product, which was collected from a donor with an elevated body temperature, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_____________________________ PRODUCT MYO/WIRE™ Temporary Cardiac Pacing Wire. Recall # Z-0305-3. The wire has a piece for connecting to a generator on one end and the opposite end has a hook shaped needle designed for contact with the heart. Outer carton labeled in part, ”MYO/WIRE***Temporary Cardiac Pacing Wire***Soft multi-stranded surgical steel wire***Extruded PTFE insulation*** ***Contents: 24 individual sterile wires***Instructions for use and warnings inside box.***Single use. Do not resterilize.” The INCORRECT Insert is labeled in part: "MYO/WIRE II Sternotomy Sutures. The CORRECT insert is labeled in part: “MYO/WIRE Temporary Cardiac Pacing Wires. CODE Catalogue No. 021-001 Lot #0378A. RECALLING FIRM/MANUFACTURER Alto Development Corp., Farmingdale, NJ, by letter on August 27, 2002. Firm initiated recall is complete. REASON Insert mixup. VOLUME OF PRODUCT IN COMMERCE 120 boxes of 24 devices. DISTRIBUTION Nationwide and in Europe. _____________________________ PRODUCT AC/DC portable aspirators manufactured under the following brand names: Gomco OptiVac Aspirator, Model G178; w/carrying case, Model GC178 Life Support Products OptiVac Aspirator, Model L178; w/carrying case, Model LC178 Schuco OptiVac Aspirator, Model S178; w/carrying case Model SC178 RX device. Recall # Z-306-3. CODE Units with a serial number beginning with the letter T, U, or V or any units with a serial number that starts with the year 1999, 2000, or 2001 (for example T9274 or 20010426002). RECALLING FIRM/MANUFACTURER Allied Healthcare Products, Inc., St. Louis, MO, by letter on October 7, 2002. Firm initiated recall is ongoing. REASON Power supply could overheat. VOLUME OF PRODUCT IN COMMERCE 5,780 units. DISTRIBUTION Nationwide. _____________________________ PRODUCT Boehringer Suction Regulator, Suction Regulator. Recall # Z-0309-3. CODE Model number 3710 Lot numbers 01I, 01J, and 01K. RECALLING FIRM/MANUFACTURER Boehringer Laboratories, Norristown, PA, by telephone June 7, 2002. Firm initiated recall is ongoing. REASON Units provided three positions instead of the described two. VOLUME OF PRODUCT IN COMMERCE 34 units. DISTRIBUTION VA and CA. _____________________________ PRODUCT Spacelabs Burdick Cassette Holter Recorders, Models 90205 (2 channel) and 90208 (3 channel). Recall # Z-0311-3. CODE Model 90205 (2 Channel) Holter Recorders with the following serial numbers are subject to the recall: 10730001128, 10730001129, 10730001130, 10730001131, 10730001132, 10730001133, 10730001134, 10730001135,10730001136, 10730001137, 10730001139, 10730001140, 10730001142, 10730001145, 10730001146, 10730001148, 10730001151, and 10730001152. Model 90208 (3 Channel) Holter Recorders with the following serial numbers are subject to the recall: 10740000903, 10740000905, 10740000906, 10740000907, 10740000908, 10740000909, 10740000910, 10740000911, 10740000912, 10740000913, 10740000914, 10740000919, 10740000920, 10740000923, 10740000925, 10740000927, 10740000928, and 0740000929. RECALLING FIRM/MANUFACTURER Spacelabs Burdick, Inc., Deerfield, WI, by letters dated November 5, 2002. Firm initiated recall is ongoing. REASON The tape head slide spring may cause the tape speed to change. VOLUME OF PRODUCT IN COMMERCE 36 units. DISTRIBUTION CA, NM, TN, VA and Germany and Portugal. _____________________________ PRODUCT a) Micro-Lite Phototherapy System, Model PTS68-1, Recall # Z-1324-2; b) Infant Intensive Care System 7850 Phtotherapy, Model PTM78-3. Recall # Z-1325-2. CODE Model PTS68-1 all serial numbers since original release in February 1999. RECALLING FIRM/MANUFACTURER Hill-Rom Air-Shields, Hatboro, PA, by letter dated May 20, 2002. FDA initiated recall is ongoing. REASON The power supply malfunctions, causing the unit to become inoperable. VOLUME OF PRODUCT IN COMMERCE 825 units (MicroLite) and 1619 units (PTM78-3). DISTRIBUTION Nationwide and Internationally.END OF ENFORCEMENT REPORT FOR DECEMBER 4, 2002 ####
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