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.
 ENFORCE
10/21/1992

RECALLS AND FIELD CORRECTIONS: October 21, 1992

                                 FOODS -- CLASS II
                                                              92-43
              
PRODUCT        Fresh tuna, unlabeled, varying weights ranging from 61 pounds    
               to 216 pounds:  (a) Yellow Fin Tuna; (b) Big Eye Tuna.
               Recall #F-538/539-2.
CODE           None.
MANUFACTURER   Phillips Seafood, Inc., Point Pleasant, New Jersey.
RECALLED BY    Manufacturer, by telephone May 21, 1992.  Firm-initiated recall  
               complete.
DISTRIBUTION   New Jersey, Rhode Island, Massachusetts, Maryland.
QUANTITY       12 units were distributed; firm estimates none remains on the    
               market.
REASON         The product is decomposed and contains histamines.

              
PRODUCT        Mushrooms, in 4 ounce cans, under Eastwind and Parade labels.    
               Recall #F-094-3.
CODE           Lot #CMPS 1518.
MANUFACTURER   S.K. Foods, Inc., Bangkok, Thailand.
RECALLED BY    Connell Foods, Inc., Westfield, New Jersey, by telephone July    
               14, 1992, and by letter July 15, 1992.  Firm-initiated recall    
               ongoing.
DISTRIBUTION   New York.
                                       
QUANTITY       3,000 cases (24 cans per case) were distributed; firm estimates  
               that no more than 10 percent remains on the market.
REASON         Product is contaminated with Staphylococcus enterotoxin.

              
PRODUCT        Leslie Ann brand:  (a) Mint Pastels, in 4 ounce cellophane       
               bags; (b) Candy Corn, in 5 ounce cellophane bags.
               Recall #F-096/097-3.
CODE           None.
MANUFACTURER   Becksmith Company, Cincinnati, Ohio.
RECALLED BY    Manufacturer, by memorandum August 28, 1992.  Firm-initiated     
               field correction (relabeling) complete.
DISTRIBUTION   Ohio, Kentucky, Indiana.
QUANTITY       Since June 1, 1992, the firm has distributed no bags of the      
               candy corn, and 72 bags of the mint pastels.  The firm also      
               estimates that 6 bags of mint pastels remain on the market.
REASON         Product contains undeclared FD&C Yellow No. 5.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
              
PRODUCT        (a) Pfeiffer brand Ranch Dressing, in 8 ounce glass bottles;
               (b) Marzetti brand Ranch Dressing, in 8 ounce glass bottles.     
               Recall #F-092/093-3.
CODE           Lot numbers:  (a) 1-20-93; (b) 1-25-93.
MANUFACTURER   Pfeiffer Foods, Wilson, New York.
RECALLED BY    T. Marzetti Company, Columbus, Ohio, by letter dated August 21,  
               1992.  Firm-initiated recall complete.
DISTRIBUTION   (a) Florida, New Jersey, New York, Texas; (b) Iowa, Missouri,    
               Wisconsin, West Virginia, Ohio.
QUANTITY       (a) 947 cases (12 bottles per case); (b) 942 cases (12 bottles   
               per case were distributed.
REASON         Products are contaminated with Lactobacillus bacteria.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
              
PRODUCT        Therapy Bayer Enteric Aspirin, 325 mg, in 50 and 100 count       
               bottles, and in 7-pack sample packages, an OTC analgesic.        
               Recall #D-015-3.
CODE           Lot numbers:  1C404R, 1E409R, 1F411, 1H415, 1H422, 1J420 (50     
               count); 1C404R, 1D405R, 1D407R, 1E410R, 1F411, 1F413, 1H415,     
               1H419, 1H421, 1H422, 1H423, 1J420 (100 count), 1D405R, 1D406R,   
               1E408R (7 pack sample).
MANUFACTURER   Sterling Winthrop, Myerstown, Pennsylvania.
RECALLED BY    Sterling Health, Division of Sterling Winthrop, Inc., New York,  
               New York, by letter dated September 15, 1992.  Firm-initiated    
               recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       7,674 7-pack sample were distributed, firm estimates 350,000     
               bottles of 50 and/or 100 tablets remain on the market.
REASON         Product does not meet dissolution specifications through         
               expiration date.

                                      -2-
              
PRODUCT        Flutex Cream 0.1%, (Triamcinolone Acetonide Cream, USP, 0.1%),   
               in 4 ounce tubes, a Rx drug.  Recall #D-016-3.
CODE           Lot #G216 EXP 8/93.
MANUFACTURER   Syosset Laboratories Company, Inc., Syosset, New York.
RECALLED BY    Manufacturer, by telephone August 27, 1992.  Firm-initiated      
               recall complete.
DISTRIBUTION   California, Georgia.
QUANTITY       79 units were distributed.
REASON         80 gram size was mislabeled as 4 ounces.

              
PRODUCT        Blue Lightning Therapeutic Rub, an OTC analgesic balm, in 8      
               ounce jars.  Recall #D-017-3.
CODE           Lots #H311 EXP 1/94.
MANUFACTURER   Syosset Laboratories, Company, Inc., Syosset, New York.
RECALLED BY    Manufacturer, by letter September 25, 1992.  Firm-initiated      
               recall ongoing.
DISTRIBUTION   Florida, Virginia, Georgia, Maryland, New York, Louisiana.
QUANTITY       1,586 units were distributed.
REASON         Product contains 2% menthol.  Label incorrectly declares 4%.

              
PRODUCT        Thioridazine HCl Oral Solution, USP (Concentrate) 100 mg/3.4     
               ml, a Rx oral psychotropic used for the management of            
               manifestations of psychotic disorders.  Recall #D-018-3.
CODE           Lot #202606 EXP 8/93, 204609 EXP 2/94, 205614 EXP 2/94.
MANUFACTURER   Pharmaceutical Basics, Inc. (PBI), Morton Grove, Illinois.
RECALLED BY    Xactdose, Inc., South Beloit, Illinois, by letter October 5,     
               1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       734 cartons (10 cups per tray, 10 trays per carton) were         
               distributed; firm estimates 75 cartons remain on the market.
REASON         Product fails stability specifications for color prior to        
               expiration date.

              
PRODUCT        Chlorpromazine HCl Oral Concentrate, USP, 100 mg/3.4 ml, an      
               oral psychotropic used for the management of manifestations of   
               psychotic disorders, in 3.4 ml unit dose cups.  Recall #D-019-3.
CODE           Lot numbers:  202608 EXP 12/93, 206602 EXP 12/93.
MANUFACTURER   Roxane Labs., Inc., Columbus, Ohio.
RECALLED BY    Xactdose, Inc., South Beloit, Illinois, by letter September 29,  
               1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       492 cartons (10 cups per tray, 10 trays per carton) were         
               distributed; firm estimates 75 cartons remain on the market.
REASON         The solution reacted with the aluminum foil cups causing         
               leakage. 

                                      -3-
RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
              
PRODUCT        (a) Whole Blood; (b) Red Blood Cells.  Recall #B-439/440-2.
CODE           Unit numbers:  (a) S66253; (b) S68115, S68116.
MANUFACTURER   San Diego Blood Bank, San Diego, California.
RECALLED BY    Manufacturer, by telephone September 30, 1991, and December 30,  
               1991.  Firm-initiated recall complete.
DISTRIBUTION   California.
QUANTITY       (a) 1 unit; (b) 2 units.
REASON         Blood products labeled with incorrect expiration dates were      
               distributed.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
              
PRODUCT        Medionics QC Transfer Sets, sterile, Rx quick connect device     
               used between the patient line and tubing set during peritoneal   
               dialysis:  (a) Medionics' Catalog #QT008C, Abbott List #2661;    
               (b) Medionics' Catalog #QT-008CA, Abbott List #21662.
               Recall #Z-1257/1258-2.
CODE           Lot numbers: 
               Medionics                         Abbott
               (a) 910520 through 911120        54-026J2 through 61-009J2
               (b) 910626                       55021J2.
MANUFACTURER   Medionics International, Inc., Markham, Ontario, Canada.
RECALLED BY    Abbott Laboratories, Hospital Products Division, Abbott Park,    
               Illinois, by letter February 6, 1992.  Firm-initiated recall     
               ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       (a) 9,400 sets; (b) 418 sets were distributed; firm estimates    
               none remains on the market.
REASON         Sets may develop a leak at the distal connection site when       
               connected to the Abbott Cycler Set or Biocap Y-set.

              
PRODUCT        Marathon Guiding Catheter, Model 77-160S-8F, JL5.0 STD.
               Recall #Z-008-3.
CODE           Lot #2D0563-4037.
MANUFACTURER   Baxter Healthcare Corporation, Edwards LIS Division, Irvine,     
               California.
RECALLED BY    Manufacturer, by letter July 13 and 14, 1992.  Firm-initiated    
               recall ongoing.
DISTRIBUTION   Alabama, Arizona, California, Georgia, Hawaii, Illinois,         
               Kansas, Louisiana, Michigan, Minnesota, Missouri, New Jersey,    
               Pennsylvania, Tennessee, Tesas, Wisconsin, France, Japan,        
               Belgium, Israel.
QUANTITY       212 units were distributed.  FDA estimates that very little      
               product remains on the market.
REASON         The device was labeled as a "JL5.0" catheter (Judkins-left, 5.0  
               cm width) but contained a "JL4.0" catheter.

                                      -4-
              
PRODUCT        Foursight Visual Systems Model 4 Laser Projector.
               Recall #Z-013-3.
CODE           Serial #001.
MANUFACTURER   Crystal Cathedral, Garden Grove, California.
RECALLED BY    Manufacturer.  FDA approved the firm's corrective action plan    
               September 23, 1992.  Firm-initiated field correction ongoing.
DISTRIBUTION   California.
QUANTITY       1 unit.
REASON         Noncompliance with performance standard for laser products in    
               that the removable lasers incorporated in the projector are not  
               certified to be in compliance with the performance standard;     
               the portions of the protective housing designed to be removed    
               for user maintenance are not safety interlocked; there is no     
               user information that complies with the performance standard;    
               and there are no certification or identification labels as       
               required.

              
PRODUCT        UroView Fluoroscopic Urology System.  Recall #Z-016-3.
CODE           Serial numbers:  Undetermined.
MANUFACTURER   OEC-Diasonics, Salt Lake City, Utah.
RECALLED BY    Manufacturer.  FDA approved the firm's corrective action plan    
               August 17, 1992.  Firm-initiated field correction ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       53 units were distributed.
REASON         Noncompliance with the performance standard for diagnostic       
               x-ray products in that it failed to meet the primary protective  
               barrier-limitation of useful beam as required.


RECALLS AND FIELD CORRECTIONS:  VETERINARY -- CLASS II
              
PRODUCT        Tiguvon brand of Fenthion Cattle Insecticide Pour-on, in 1       
               gallon metal containers, for the control of grubs and lice on    
               cattle.  Recall #V-003-3.
CODE           Lot numbers:  440045, 440068, 440094, 440046, 440069, 440095,    
               440047, 440073, 440100, 440048, 440078, 440101, 440052, 440082,  
               440102, 440053, 440084, 440103, 440054, 440092, 440104, 440065,  
               440093, 440121.
MANUFACTURER   Miles, Inc., Animal Health Products Division, Shawnee Mission,   
               Kansas.
DISTRIBUTION   Nationwide.
QUANTITY       144,000 1-gallon cans distributed.
REASON         Product becomes subpotent prior to end of 36-month expiration    
               date.


MEDICAL DEVICE SAFETY ALERTS:
              
PRODUCT        Autotransfusion System, Model AT1000, used to collect, clean     
               and return blood to a patient during surgery.
               Safety Alert #M-001-3.

                                      -5-
CODE           All serial numbers.
MANUFACTURER   Electromedics, Inc., Englewood, Colorado.
ALERTED BY     Manufacturer, by letter August 24, 1992.
DISTRIBUTION   Nationwide, Australia, Germany.
QUANTITY       409 units were distributed.
REASON         Centrifuge bowl may crack during operation.


INJUNCTION:
              
PRODUCT        Crabmeat (92-652-513).
CHARGE         Adulterated - The crabmeat contains a filthy substance,          
               indicated by the presence of E. coli, and by the presence of     
               blow flies (calliphoridae), and is further adulterated in that   
               it has been prepared, packed, or held under insanitary           
               conditions whereby it may have become contaminated with filth.
AGAINST        Seafood, Inc. of Henderson, Louisiana, and Pamela A.
               Friedman, Charles J. Friedman, and Steven LeGrand.
FILED          Complaint, September 29, 1992; Consent Decree of Permanent
               Injunction, October 8, 1992; U.S. District Court for the
               Western District of Louisiana, Lafayette-Opelousas Division;
               Civil #92-1819, INJ 1305.


SEIZURES:
              
PRODUCT        Canned sardines (92-664-536).
CHARGE         Adulterated - The product consists in whole or in part of a
               decomposed substance.
FIRM           Shimaya Shoten, Ltd., Honolulu, Hawaii.
FILED          October 1, 1992; U.S. District Court for the District
               of Hawaii; Civil #92 00639 SPK, FDC #66606.
SEIZED         October 7, 1992 - goods valued at approximately $11,600.

              
PRODUCT        Various articles of food (92-667-308).
CHARGE         Adulterated - Four lots of product contain various elements
               of filth, including insects, insect fragments, feather
               barbules, and rodent and other animal hair.
               Misbranded - One lot contains artificial coloring, a yellow
               carotenoid color additive, and the product label fails to
               state that fact.
FIRM           Seasia/Uwajimaya, Inc., Seattle, Washington.
FILED          August 18, 1992; U.S. District Court for the Western
               District of Washington; Civil #C92-1296, FDC #66452.
SEIZED         August 24, 1992 - goods valued at approximately $6,000.


                                      -6-


END OF ENFORCEMENT REPORT FOR OCTOBER 21, 1992.  BLANK PAGES MAY
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