FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

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.





[FDA HOME PAGE]