SEPTEMBER 3, 1997 97-36 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT: Refrigerated Potato Salad Products, Orval Kent Food Products, Pathmark, Demoulas, Giant of Landover Maryland, Acme Markets, Marsh Supermarkets labels in lb.., 2lb., 3lb., plastic containers, 5lb and10lb bulk containers. Recall# F-684/F-713-7. CODE: W7. MANUFACTURER: Oral Kent Food Company, Inc., Wheeling Illinois. RECALLED BY: Manufacturer, on August 4, 1997. Firm-initiated recall complete. DISTRIBUTION: Canada, Oklahoma, Mississippi, South Dakota, Kansas, Georgia, Florida, Colorado, Maryland, Canada,Puerto Rico, New York. QUANTITY: 5,644,170 pounds were distributed. REASON: Potato salads may be contaminated with Listeriamonocytogenes. _______________ PRODUCT: Ranch Dressing under the Western Family, Nally,and OPA Konings Wholesale labels. Recall#F-798-7. CODE: All codes. MANUFACTURER: Nally's Fine Foods, Inc. Tacoma, Washington. RECALLED BY: Manufacturer, on July 25, 1997. Firm issued press release with the Canadian food Inspection Agency. DISTRIBUTION: Canada. Firm-initiated recall ongoing. QUANTITY: 48,036/500 ml bottles, 28,872/1L bottles, 2044/4L bottles, 4,502/4L bottles were distributed. REASON: Product contains undeclared egg ingredient. _______________ PRODUCT: Oatmeal Raisin Cookies, 24 carton packages. Recall #F-799-7. CODE: All with sale dates of February 17 or earlier. MANUFACTURER: Smith Food and Drug Inc., Salt Lake City, Utah. RECALLED BY: Manufacturer, February 26, 1997. Firm-initiated recall complete. DISTRIBUTION: Arizona, New Mexico, Nevada. QUANTITY: 34 cases were distributed. REASON: This product contains undeclared walnuts, whole egg solids, and non fat dry milk solids. _______________ PRODUCT: Royal Line brand Smoked Salmon Recall #F-801-7. CODE: Uncoded. MANUFACTURER: Slaturvirkid a Tijorn, Faroe Islands (Denmark), RECALLED BY: Marine Marketing International, Inc. August 5, Firm-initiated recall complete. DISTRIBUTION: Calfornia. QUANTITY: Not known. REASON: Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT: Various Drinks under the Brookshire Bros., or Land O'Pines labels Recall #F-788-7/F-796-7. CODE: Various codes. MANUFACTURER: Land O'Pines Dairy Products Co., Lufkin, Texas. RECALLED BY: Manufacturer, on March 11, 1997. Firm-initiated recall ongoing. DISTRIBUTION: National. QUANTITY: Unknown. REASON Products are contaminated with mold and yeast. 2 _______________ PRODUCT: a) JW ALLEN YELLOW CUPCAKES, 6 PKG., b)JW ALLEN YELLOW CUPCAKES, 12 PKG.,c)JW ALLEN CHOCOLATE CUPCAKES, 6 PKG., d)JW ALLEN CHOCOLATE CUPCAKES, 12 PKG., e)JW ALLEN ASSORTED CUPCAKES, 6 PKG.,f)JW ALLEN ASSORTED CUPCAKES, 12 PKG.,g)JW ALLEN YELLOW UNICED LAYER,h)JW ALLEN YELLOW ICED LAYER(DOUBLE)I) JW ALLEN ´ SHEET CHOCOLATE CAKE j)JW ALLEN 1/4 SHEET DECORATED CHOCOLATE CAKE,k)JW ALLEN 1/4 SHEET CHOCOLATE CAK E W/DECO PAC,L) JW ALLEN ´ SHEET CHO COLATE CAKE W/DECO PAC, M)JW ALLEN FULL SHEET CAKE, CHOCOLATE,N)JW ALLEN FULL SHEET CHOCOLATE CAKE, W/DECO PAC, O)JW AL LEN MARBLE FULL SHEET CAKE, P)JW ALLEN MARBLE 1/4 SHEET CAKE, Q)JW ALLEN MARBLE 1/4 SHEET CAKE W/DECO PAC, R)JW ALLEN MARBLE ´ SHEET CAKE,S)JW ALLEN MARBLE ´ SHEET CAKE W/DECO PAC, T)JW ALLEN MARBLE FULL SHEET CAKE W/DECO PAC, U)ORANGE BAKE APPLE STRUDEL, V) ORANGE BAKE CHERRY STRUDEL, W)ORANGE BAKE PINEAPPLE CHEESE STRUDEL, X)MOTHER'S FRUIT TOPPED CHEESECAKE, Y)MOTHER'S CHOCOLATE CHIP CHEESECAKE WITH FRUIT,Y)NAPOLEON SINGLE LAYER, z)LOLLIPOP CAKE SINGLE LAYER, aa)LEMON COOKIES N CREAM SINGLE LAYER bb)CARNIVAL OF FRUIT CAKE SINGLE LAYER, cc)VANILLA & CHOCOLATE RIPPLE SINGLE LAYER dd)CHOCOLATE ALMOND KISS SINGLE LAYER ee)BANANA SPLIT CAKE SINGLE LAYER, ff)MARSHMALLOW CREME CAKE SINGLE LAYER, gg)HONEY BEE CAKE SINGLE LAYER, hh)SUNDAE CAKE SINGLE LAYER ii)APPLE SPICE CAKE SINGLE LAYER, jj)1/4 SHEET POUND CAKE (DECORATED),kk)8" ROUND PLAIN POUND CAKE (DECORATED), ll) 8" ROUND CHOCOLATE CHIP POUND CAKE (DECORATED),mm)JW ALLEN 1/4 SHEET YELLOW CAKE (FOIL),nn)JW ALLEN 1/4 SHEET CHOCOLATE CAKE (FOIL),oo)JW ALLEN ´ SHEET YELLOW CAKE, pp) JW ALLEN 1/4 SHEET DECORATED YELLOW CAKE qq) JW ALLEN 1/4 SHEET YELLOW CAKE WITH DECO rr)J W ALLEN 1/4 SHEET STRAWBERRY SHORTCA KE, ss)JW ALLEN ´ SHEET YELLOW CAKE WITH DECO tt) JW ALLEN FULL SHEET CAKE, YELLOW, uu)JW ALLEN FULL SHEET CAKE WITH DECO PAC, vv)JW ALLEN YELLOW LAYER 4"(DOUBLE), ww)JW ALLEN CHOCOLATE ICED LAYER (SINGLE), xx)JW ALLEN CHOCOLATE ICED LAYER (DOUBLE),yy)JW ALLEN CHOCOLATE LAYER 4" (DOUBLE),zz)JW ALLEN MARBLE ICED LAYER (SINGLE),aaa)JW ALLEN MARBLE ICED LAYER (DOUBLE), bbb)JW ALLEN CARROT UNICED LAYER,ccc)FUDGE YELLOW SINGLE LAYER, ddd)PINWHEEL SINGLE LAYER, eee)LEMON TORTE SINGLE LAYER, fff)M&M TREE SINGLE LAYER,ggg)STRAWBERRY DELIGHT SINGLE LAYER,hhh)GUM DROP SINGLE LAYER Recall #F-719-7/F778-7. CODE: 1200,1201,1202,1203,1204,1205,1206,1215,1216, 1218,1256,1257,1261,1262,1267,1268,1248,1249, 1272,1273,1274,1276,1277,1278,1279,1281,1282, 1285,1286,1289,1290,1327,1328,1357,1358,1374,1375,1376,1377,1378,1379,1380,1386,1387,1388,1389,1391,1392,1393,1394,1446,1447,1448,1586,1587,1686,1687,1688,1689. MANUFACTURER: Acme Markets, Inc., Malvern, Pennsylvania. RECALLED BY: Manufacturer, on June 27, 1997. Firm-initiated recall complete. DISTRIBUTION: Delaware, Maryland, New Jersey, and Pennsylvania. QUANTITY: Not known. REASON: Ingredient statement for the involved products failed to declare any FD&C colors. _______________ PRODUCT: Darigold brand Vanilla Ice Cream, half gallon square cardboard carton Recall #F-716-7. CODE: All products with "1747" Julian date stamp. MANUFACTURER: Darigold, Inc., Seattle, Washington. RECALLED BY: Manufacturer, on July 30, 1997. Firm-initiated recall ongoing. DISTRIBUTION: Washington, California, Oregon, Montana, Michigan. QUANTITY: 23,875/half gallon containers were distributed. REASON: The product is contaminated with ammonia. _______________ PRODUCT: Gillette Satin Care for Women -- Moisture Rich Shave Gel Dry Skin Recall #F-800-7. CODE: Lot # 7169. MANUFACTURER: Gillette Company, Boston, Massachusett. RECALLED BY: Manufacturer, June 16, 1997. Firm-initiated recall ongoing. DISTRIBUTION: Arkansas, Florida, Illinois, Minnesota, New York Ohio, New Jersey, Pennsylvania, Rhode Island, Vermont, Wisconsin. QUANTITY: 465 cases were distributed. REASON: This product is contaminated with Burkholderia cepacia, a pathogen. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT: Hershey Sweet Escapes Triple Chocolate Wafer Bars 1.4 ounces, Hershey Sweet Escapes Triple Chocolate Wafer Bars, 0.7 ounces, 9-count pouch Recall #F-717-7/F-718-7. CODE: 63NTN, 63PTR, 63PTV, 58D, 58E, 60B, 61L, 61N, 61P. 4 MANUFACTURER: Hershey Chocolate U.S.A., Hershey, Pennsylvania. RECALLED BY: Manufacturer, May 6, 1997. Firm-initiated recall complete. DISTRIBUTION: Nationwide,Canada. QUANTITY: 47,385 cases were distributed. REASON: Unfit for food due to off-odor and off-taste. _______________ PRODUCT: Claw Crab Meat Recall #F-797-7. CODE: 182 on cups, 182 c/m 40 on shipping boxes. MANUFACTURER: May's Seafood, New Orleans, Louisana. RECALLED BY: Manufacturer,recall via phone to customers on July 2, 1997. Firm-initiated complete. DISTRIBUTION: Louisiana. QUANTITY: 109/1 pounds cups were distributed. REASON: Product was decomposed. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ========== _______________ PRODUCT: Clindamycin Hydrochloride Capsules Recall#D-252-7. CODE: lot# 20847, 20848, 28125, 28126, 28127. MANUFACTURER: EVA Pharmaceuticals USA, Inc., Sellersville, Pennsylviana. RECALLED BY: Manufacturer, on or about July 15, 1997. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 1,597 X 100 bottles were distributed. REASON: labeling: Incorrect expiration date. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT: Nitrostat sublingual tablets. Recall #D-253-7. CODE: 063N5F. MANUFACTURER: Parke-Davis, Division of Warner Lambert Co., Morris Plains, New Jersey. RECALLED BY: Manufacturer, on June 27, 1997 via certified mail. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 48,946 bottles were distributed. REASON: Lot may not meet assay specifications through the shelf-life of the product. _______________ PRODUCT: Testoderm with Adhesive Recall #D-254-7. CODE: 147831,150889,1508890, 150891. MANUFACTURER: Alza Corporation, Vacaville, Calfornia. RECALLED BY: Manufacturer, on July 31, 1997. Firm-initiated recall ongoing. 5 DISTRIBUTION: Nationwide. QUANTITY: 30 cartons were distributed. REASON: out of specifications for the 4 new release rates. PRODUCT: Isocom Capsules Recall #D-256-7. CODE: Lot# 48550A, 48550B, 48663, 48779V, 49132,48863. MANUFACTURER Glenwood Palisades, Piscataway, New Jersey. RECALLED BY: Manfacturer. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 31,834 bottles were distributed. REASON: Failed dissolution and/or assay. RECALLS AND FIELD CORRECTION: BIOLOGICS -- CLASS I ========== _______________ Product: Antihemophilic Factor (Recombinant), Recombinate, Recall #B-1084-7. Code: Lot #s 2938M228AA, 2938M229AA, 2938M230AA. Manufacturer: Baxter Health Care Corporation. Recalled by: Baxter Healthcare Corporation, Hyland Division, Glendale, California, on July 14, 1997. Firm-initiated recall complete. Distribution: Nationwide. Quantity: 5,324 kits were distributed. Reason: The sterility of Baxters Antihemophilic Factor (Recombinant), which is aseptically processed, may have been compromised. During routine quality assurance testing, media fills failed because of the presence of penicillium mold in the media fill vials. Breaches in the integrity of the HEPA filters and the duct work were also reported. RECALLS AND FIELD CORRECTION: BIOLOGICS -- Class II ========== ______________ Product: (a)Red Blood Cells; (b) Platelets; (c) Fresh Frozen plasma; (d) Platelets, for further manufacture; Recall #B-1302/1305-7. Code: (a) 11 units; (b) 8 units; (c)1 unit; (d) 4 units. Manufacturer: United Blood Services, Lubbock, Texas. Recalled by: Blood Systems, Inc., Scottsdale, Arizona by letters May 31, 1997. Firm-initiated recall ongoing. Distribution: Texas, New Mexico. Quantity: 24 units were distributed. Reason: Blood products, which tested negative for the antibody to the human T-lyaphotropic virus type 1,(anti-HTLV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-1 were distributed. 6 _______________ Product: (a) Red Blood Cells; (b) Platelets; Recall #B-1288/1289-7. Code: Unit #22383-8850, 22382-9065. Manufacturer: United Blood Services, Las Vegas, Nevada. Recalled by: Blood Systems, Inc., Scottsdale, Arizona by letter dated March 19, 1997. Firm-initiated recall complete. Distribution: Mississippi, Nevada. Quantity: 2 units were distributed. Reason: Blood products collected from a donor who traveled an area considered endemic for malaria, were distributed. _______________ Product: Red Blood Cells, Recall #B-1290-7. Code: Unit #23130-8226. Manufacturer: United Blood Services, Billings, Montana. Recalled by: Blood Systems, Inc., Scottsdale, Arizona by letter dated February 18, 1997. Firm-initiated recall complete. Distribution: Montana. Quantity: 1 unit was distributed. Reason: Blood product collected from a donor who traveled an area considered endemic for malaria, were distributed. _______________ Product: Red Blood Cells, Platelets, Fresh Frozen Plasma, Recall #B-1291/1293-7. Code: Unit #29086-5437. Manufacturer: United Blood Services, Chicago, Illinois Recalled by: Blood Systems, Inc., Scottsdale, Arizona by letter dated May 18, 1997. Firm-initiated recall complete. Distribution: Illinois. Quantity: 1 unit was distributed. Reason: Blood products, which tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, were distributed. _______________ Product: Red Blood Cells, Platelets, Recovered Plasma, Recall #B-1294-1296-7. Code: Unit # 31019-7084. Manufacturer: United Blood Services, Tupelo, Mississippi. Recalled by: Blood Systems, Inc., Scottsdale, Arizona by letter dated February 18, 1997. Firm-initiated recall complete. Distribution: Alabama, Mississippi, North Carolina. 7 Quantity: 1 unit was distributed. Reason: Blood products, collected from a donor who had previously self-exclude, were distributed. _______________ Product: Recovered Plasma, Recall #B-1301-7. Code: Unit #10161-6406. Manufacturer: United Blood Services, Scottsdale, Arizona Recalled by: Blood Systems, Inc. Scottsdale, Arizona by letter dated March 19, 1997. Firm-initiated recall complete. Distribution: North Carolina. Quantity: 1 unit was distributed. Reason: Blood product, which tested negative for the hepatitis B surface antigen (HbsAg), but was collected from a donor who previously tested repeatedly reactive for HbsAg and the antibody to the hepatitis B core antigen (anti-HBc) was distributed. _______________ Product: (a) Red Blood Cells, (b)Recovered Plasma, Recall #B-1266/1267-7. Code: Unit #15031-1649, 15028-6674. Manufacturer: United Blood Services, Albuquerque, New Mexico. Recalled by: Blood Systems, Inc., Scottsdale, Arizona by letter July 7, 1997. Firm-initiated recall complete. Distribution: Texas, Switzerland. Quantity: 2 units were distributed. Reason: Blood products, collected from a donor who was implicated in a post transfusion hepatitis case, were distributed. _______________ Product: Red Blood Cells, Fresh Frozen Plasma, Recall #B-1279/1280-7. Code: Unit #10203-5598. Manufacturer: United Blood Services, Scottsdale, Arizona Recalled by: Blood Systems, Inc., Scottsdale, Arizona by letter on July 10, 1997. Firm-initiated recall ongoing. Distribution: Arizona. Quantity: 1 unit was distributed. Reason: Blood products, collected from a donor with a history of hepatitis, were distributed. _______________ Product: Recovered Plasma, Recall #B-1209-7. Code: Unit #04LK30713. Manufacturer: Mercy Hospital Blood Bank. 8 Recalled by: Mercy Hospital Blood Bank, Springfield, Massachusetts by telephone July 21, 1997 and by letter dated July 22, 1997. Firm-initiated recall complete. Distribution: Pennsylvania. Quantity: 1 unit was distributed. Reason: Blood product, which tested repeatedly reactive for Human Immunodeficiency virus type 1 (HIV-1) p24 antigen neutralization indeterminate, were distributed. _______________ Product: Platelets, Recall #B-1314-7. Code: Unit #03KM06034. Manufacturer: American Red Cross. Recalled by: American Red Cross Blood Services Southern Region, Atlanta, Georgia, by telephone June 12, 1997 and by letter June 19, 1997. Firm iniated recall complete. Distribution: Florida. Quantity: 1 unit was distributed. Reason: Blood product, which was prepared from a whole blood unit with extended collection time, was distributed. _______________ Product: (a) Red Blood Cells; (b) Plasma Frozen; (c) Buffy Coat, Recall #B-1090/1092-7. Code: Unit #'s (a-c) 53GN03529, 53GN03530, 53GN03532. Manufacturer: American National Red Cross. Recalled by: American National Red Cross Greater Chesapeake and Potomac Region, Baltimore, Maryland. Distribution: Maryland, New Jersey. Quantity: 9 units were distributed. Reason: Unit of pooled Platelets, implicated in a post transfusion reaction, were found to be contaminated with Yersinia enterocolitica. Corresponding blood products were distributed. _______________ Product: Platelets, Recall #B-1313-7. Code: Unit #24KJ26529. Manufacturer: American National Red Cross. Recalled by: American Red Cross Blood Services, Louisville, Kentucky, by letter June 6, 1997. Firm-initiated recall complete. Distribution: Kentucky. Quantity: 1 unit was distributed. Reason: Blood product, which was prepared from a whole blood unit with extended collection time, was distributed. 9 _______________ Product: Red Blood Cells, Recovered Plasma, Recall #B-1284/1285-7. Code: Unit #10221-1003. Manufacturer: United Blood Services, Scottsdale, Arizona. Recalled by: Blood Systems, Inc., Scottsdale, Arizona by letter July 10, 1997. Firm-initiated recall ongoing. Distribution: Illinois. Quantity: 1 unit was distributed. Reason: Blood products, collected from unsuitable donor, were distributed. _______________ PRODUCT: Red Blood Cells, Fresh Frozen Plasma, Recovered plasma Recall #B-281-7/283-7. CODE: B-1281-7, B-1282-7, B-1283-7. MANUFACTURER: United Blood Services, Scottsdale, Arizona. RECALLED BY: Blood Systems Inc., by phone on July 10, 1997, Firm-iniated recall complete. DISTRIBUTION: Arizona and Switzerland. QUANTITY: 3 units were distributed. REASON: Product was collected from a donor, who may be a duplicate of a donor who was deferred in May of 1989, after a history of IV drug use. _______________ PRODUCT: Red Blood Cells, Cryoprecipitate Recall #B-1270-7/B-1272-7. CODE: 19019-7405, 19024-9403, 19023-3836, 19019-7405. MANUFACTURER: United Blood Services, Scottsdale, Arizona. RECALLED BY: Blood Systems Inc.,Scottsdale, Arizona., by letter on July 10,1997. Firm initiated recall complete. DISTRIBUTION: Nevada, New Mexico, North Carolina and Switzerland. QUANTITY: 3 units were distributed. REASON: Products were recalled due to collection from a donor who may be a duplicate of a donor who was deferred in December 1983 for a history of liver disease, hepatitis, or a positive test for hepatitis. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======= _______________ PRODUCT: Red Blood Cells Recall #B-1337-7 CODE: Unit 22LY38999. MANUFACTURER: American Red Cross Blood Services, Philadelphia, Pennsyvliana. RECALLED BY: Manufacturer, by telephone on February 19, 1997, Firm-initiated recall complete. 10 DISTRIBUTION: Pennsylvania. QUANTITY: 1 unit was distributed. REASON: Product was labeled with an extended expiration by one day. _______________ PRODUCT: Recovered Plasma recall# B-1306-7 CODE: Contact Center for specific codes. MANUFACTURER: United Blood Services, Lubbock, Texas. RECALLED BY: Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 28, 1997. Firm-initiated recall complete. DISTRIBUTION: Maryland, North Carolina, Virgirnia. QUANTITY: 7 units were distributed. REASON: Blood products, which tested negative for the antibody to the human T-lyaphotropic virus type 1,(anti-HTLV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-1 were distributed. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT: Impaction Drill Bur Guard Recall #Z-870-7 CODE: Part No. 2296-301 MANUFACTURER: Stryker Instruments, Divison of Stryker Instruments RECALLED BY: Manufacturer,by telephone July 10 & 11, 1997. Firm-initiated complete. DISTRIBUTION: Nationwide. QUANTITY: 130 Bur Guards were distrbuted. REASON Device has defect presents a low risk of adverse health consequences. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT: Sones B Cardiovascular catheter Recall #Z-869-7. CODE: Lot # 07HG1759. MANUFACTURER: USCI Division, C.R. Bard, Inc., Billerica, Massachusett. RECALLED BY: Manufacturer, by letter on July 28, 1997. Firm- initiated recall ongoing. DISTRIBUTION: California, Flordia, Georgia, Illinois, Ohio, Michigan. QUANTITY: 100 units were distributed. REASON: Product mislabeled. 11 RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II === _______________ PRODUCT: Vita-Lac-Power, IBA Vita-Lac Cattle Boluses, Nutriment Cattle Boluses Recall #V-043-7/#V-045-7. CODE: Unknown MANUFACTURER: Golden West Livestock Products, Cere, CA. RECALLED BY: Manufacturer, by letter on August 21, 1997. Firm initiated recall complete. DISTRIBUTION: California, Oregon, Washington, Nebraska, Massachusetts and New York. QUANTITY: 283 jars were distributed. REASON: Formulation accompanied by directions for use makes the selenium being administered to each animal superpotent. _______________ PRODUCT: Zip-all-around (14%) (non-medicated) complete feed for weaned beef cattle and horses Recall #V-042-7. CODE: Lot# A7D0469. MANUFACTURER: Feed Rite Inc., DBA Zip Feed Mills, Sioux Falls, South Dakota. RECALLED BY: Manufacturer, by telephone on July 11, 1997. Firm-initiated recall complete. DISTRIBUTION: Iowa, North Dakota and South Dakota. QUANTITY: 239/50 pounds fifty pound bags were distributed. REASON: Likely contamination with rumensin 80 (monensin). END OF ENFORCEMENT REPORT FOR September 3, 1997. BLANK PAGES MAY FOLLOW.