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
03/13/1996

 ENFORCEMENT REPORT FOR 03/13/96 


March 13, 1996                                      96-11

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I ============
_______________
PRODUCT        Nature Valley Oats 'N Honey Crunchy Granola
               Bars, in 10 ounce boxes.  Recall #F-325-6.
CODE           Lot numbers:  E509C2, E509C1 and E509C3.
MANUFACTURER   Coosa Baking Company Rome, Georgia.
RECALLED BY    General Mills, Inc., Minneapolis, Minnesota,
               by letter and by press release on January 20,
               1996.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       Approximately 10,000 cases (12 boxes per case)
               were distributed.
REASON         Product contains undeclared peanuts or peanut
               products.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III ==========
_______________
PRODUCT        Contadina Tomato Paste:
               (a) 12 oz. Contadina Tomato Paste (48/12 oz.
               or 24/12 oz. case packs);
               (b) 18 oz. Contadina Tomato Paste (24/18 oz.
               case packs);
               (c) 6 oz. Contadina Italian Tomato Paste (24/6
               oz. case packs);
               (d) 6 oz. Contadina Tomato Paste (48/6 oz. or
               96/6 oz. case packs).  Recall #F-319/322-6.
CODE           (a) Product Code: 50000-04416 (Note: 24/12 oz
               case is labeled 50000-04406 on the case but is
               labeled 50000-04416 on the can), Mfg Code on
               can end (first five digits):
               AF127   AF226   AG201   AG202   AG204  AG205 
               AG208   WG202*  WG205*  WG206*  WG212*  WG213*
               WG214*  WG215*  WG216*  WG217*  WG218*  WG219*
               WG220*  WG221*  WG222*  WG223*  WG224*  WG225
               WG227   WH214   WH224   WH226   WH228   WH229
               WH230   WH231   WJ206   WJ218   WJ219.  
               (b) Product Code 50000-04436 (24/18 oz. Case
               Pack) Mfg Code on can end first 5 digits:
               WG204*   WG219*   WG226   WJ204    WG213* 
               WG220*   WG227    WJ205   WG214*   WG221*
               WG228    WJ206    WG215*  WG222*   WG229 
               WJ207    WG216*   WG223*  WG230    WJ208
               WG217*   WG224*   WH203   WG218*   WG225  
               WJ202
               (c) Product Code 50000-04456 (24/6 oz. Case
               Pack) Mfg Code on can end first 5 digits:
               WG206*   WG219*   WG208*  WG220*  WG209*
               WG221*   WG211*   WG222*  WG214*  WG223*
               WG217*   WG230    WG218*  WG231 
               (d) Product Code 50000-04106 (48/6 oz. or 96/6
               oz. Case Packs) (Note: 48/6 oz case is labeled
               50000-04206 on the case, but is labeled
               50000-04106 on the can ).  Mfg. Code on can
               end first 5 digits:
               AG214    AH229   WG225    WH211     WJ201
               AG216    AH231   WG226    WH212     WJ202
               AG217    AJ102   WG227    WH213     WJ203
               AG218    AJ201   WG228    WH214     WJ204
               AG219    AJ202   WG229    WH215     WJ205
               AG223    AJ203   WG22F    WH216     WJ206
               AG224    AJ204   WG230    WH218     WJ207
               AH201    AJ205   WH201    WH219     WJ208
               AH202    AJ209   WH202    WH220     WJ209
               AH206    AJ211   WH203    WH225     WJ211
               AH207    WG202*  WH204    WH226     WJ212
               AH214    WG203*  WH205    WH227     WJ213
               AH215    WG204*  WH206    WH228     AH216
               WG209*   WH207   WH229    AH221     WG222*
               WH208    WH230   AH222    WG224*    WH210
               WH231   (Note:  All astrisked codes are 22%
               solids deficient, balance are cans with
               can/product compatibility deficiencies.)
MANUFACTURER   Nestle Food Company, Woodland, California and
               Modesto, California.
RECALLED BY    Nestle Food Company, Inc., Glendale,
               California, by letter or fax on or about
               August 19, 1995.  Firm-initiated recall
               complete.

                             -2-DISTRIBUTION   Massachusetts, California, Tennessee, Florida,
               New York.
QUANTITY       833,000 cases were distributed.
REASON         The products are contained in exploding cans
               and fail to meet the standard of identity for
               tomato paste.

_______________
PRODUCT        Hy-Point Farms brand of Papaya Punch, in 10
               fluid ounce bottles.  Recall #F-323-6.
CODE           All codes. 
MANUFACTURER   Mayer Brothers Apple Products, Barker, New
               York.
RECALLED BY    Mayer Brothers Apple Products, West Seneca,
               New York, by telephone followed by letter
               dated January 11, 1996 and visit.  Firm-
               initiated recall complete.
DISTRIBUTION   Delaware, Maryland, New Jersey, Pennsylvania.
QUANTITY       90 cases (24 bottles per case) were
               distributed .
REASON         Product contains undeclared FD&C Red #40.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II =======
_______________
PRODUCT        (a) Red Blood Cells; (b) Recovered Plasma. 
               Recall #B-260/261-6.
CODE           Unit #1216591.
MANUFACTURER   Carter Blood Center, Fort Worth, Texas.
RECALLED BY    Manufacturer, by letter dated December 7,
               1995.  Firm-initiated recall complete.
DISTRIBUTION   Texas and California.
QUANTITY       1 unit of each component.
REASON         Blood products, collected from a donor who had
               an accidental mucous membrane exposure to
               blood, were distributed.

_______________
PRODUCT        Platelets.  Recall #B-265-6.
CODE           Unit #11312-5721.
MANUFACTURER   Blood Systems, Inc., Scottsdale, Arizona.
RECALLED BY    Manufacturer, by telephone on October 25,
               1995, followed by letter on October 31, 1995. 
               Firm-initiated recall complete.
DISTRIBUTION   Texas.
QUANTITY       1 unit. 
REASON         Blood product, containing anti-D(Rho)
               antibodies, but labeled as negative for
               unexpected antibodies, was distributed.

                             -3-_______________
PRODUCT        Alphanater brand Antihemophilic Factor
               (Human), Factor VIII, in 10 ml vials.  
               Recall #B-266-6.
CODE           Lot #AP5014A EXP 5/97.
MANUFACTURER   Alpha Therapeutic Corporation, Los Angeles,
               California.
RECALLED BY    Manufacturer, by letters sent on November 9,
               1995 and December 28, 1995.  Firm-initiated
               recall complete.
DISTRIBUTION   Nationwide.
  QUANTITY     2,943 vials were distributed.
REASON         Factor VIII, product may have been adulterated
               in that it may contain Hepatitis A virus
               (HAV), were distributed.

_______________
PRODUCT        Source Plasma.  Recall #B-267-6.
CODE           Unit #46219299, 42930099, 42933434, 42935483,
               44200718.
MANUFACTURER   Sera-Tec Biologicals, Harrisburg,
               Pennsylvania.
RECALLED BY    Manufacturer, by letter dated December 15,
               1994.  Firm-initiated recall complete
DISTRIBUTION   California, Germany.
QUANTITY       5 units.
REASON         Blood products, collected from donors at
               increased risk for hepatitis or previously
               deferred for epilepsy, were distributed.

_______________
PRODUCT        Red Blood Cells.  Recall #B-279-6.
CODE           Unit #KC40287.
MANUFACTURER   Virginia Blood Services, Richmond, Virginia.
RECALLED BY    Manufacturer, by telephone on or about
               December 4, 1995.  Firm-initiated recall
               complete.
DISTRIBUTION   Virginia.
QUANTITY       1 unit.
REASON         Blood product, collected from a donor who had
               traveled to an area designated as endemic for
               malaria, was distributed.

_______________
PRODUCT        Recovered Plasma.  Recall #B-287-6.
CODE           Unit #W32454.
MANUFACTURER   Central California Blood Center, Fresno,
               California.
RECALLED BY    Manufacturer, by fax on or about September 29,
               1995.  Firm-initiated recall complete.
DISTRIBUTION   California.
QUANTITY       1 unit.
                             -4-
REASON         Blood product, which was not tested for any
               required viral markers, was distributed.

_______________
PRODUCT        (a) Red Blood Cells; (b) Fresh Frozen Plasma. 
               Recall #B-288/289-6.
CODE           Unit #11311-8236.
MANUFACTURER   Blood Systems, doing business as United Blood
               Services, Scottsdale, Arizona.
RECALLED BY    Manufacturer, by letter dated December 18,
               1995.  Firm-initiated recall complete.
DISTRIBUTION   New Mexico, Texas.
QUANTITY       1 unit of each component.
REASON         Blood products, which were collected from a
               donor with a history of hepatitis, was
               distributed.

_______________
PRODUCT        Platelets, Pheresis.  Recall #B-291-6.
CODE           Unit numbers:  KZ20851-1 and KZ20851-2.
MANUFACTURER   Virginia Blood Services, Richmond, Virginia.
RECALLED BY    Manufacturer, by telephone May 26, 1995. 
               Firm-initiated recall complete.
DISTRIBUTION   Maryland.
QUANTITY       2 units.
REASON         Blood products labeled with an extended
               expiration date were distributed.

_______________
PRODUCT        Red Blood Cells.  Recall #B-292-6.
CODE           Unit #KE45526.
MANUFACTURER   Virginia Blood Services, Richmond, Virginia.
RECALLED BY    Manufacturer, by telephone on or about
               December 28, 1994.  Firm-initiated recall
               complete.
DISTRIBUTION   Virginia.
QUANTITY       1 unit.
REASON         Blood product, collected from a donor who
               traveled in an area designated as endemic for
               malaria, was distributed.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets.  
               Recall #B-295/296-6.
CODE           Unit #KN26870.
MANUFACTURER   Virginia Blood Services, Richmond, Virginia.
RECALLED BY    Manufacturer, by telephone on or about May 30,
               1995.  Firm-initiated recall complete.
DISTRIBUTION   Virginia.
QUANTITY       1 unit of each component.

                             -5-REASON         Blood products, collected from a donor whose
               health history screening was inadequately
               performed, were distributed.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets.  
               Recall #B-297/298-6.
CODE           Unit #KH55934.
MANUFACTURER   Virginia Blood Services, Richmond, Virginia.
RECALLED BY    Manufacturer, by telephone on or about March
               3, 1995.  Firm-initiated recall complete.
DISTRIBUTION   Virginia.
QUANTITY       1 unit of each component.
REASON         Blood products, collected from a donor whose
               medical history screening was inadequately
               performed, were distributed.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III ======
_______________
PRODUCT        Red Blood Cells.  Recall #B-244-6.
CODE           Unit numbers:  709-4956, 709-4957, 709-4959,
               709-4960, 709-4961, 709-4962, 709-4963, 709-
               4964, 709-4965, 709-4967, 709-4968.
MANUFACTURER   Sheppard Air Force Base, Sheppard AFB, Texas.
RECALLED BY    Manufacturer, by telephone on August 21, 1995. 
               Firm-initiated recall complete.
DISTRIBUTION   California.
QUANTITY       11 units.
REASON         Blood products, which were not tested for the
               antibody to the human immunodeficiency virus
               types 1 and 2 (anti-HIV-1/2), or the hepatitis
               B surface antigen (HBsAg), were distributed.

_______________
PRODUCT        Platelets.  Recall #B-258-6.
CODE           Unit #29GC18764.
MANUFACTURER   American Red Cross Blood Services, Norfolk,
               Virginia.
RECALLED BY    Manufacturer, by letter sent on or about
               August 31, 1993.  Firm-initiated recall
               complete.
DISTRIBUTION   California.
QUANTITY       1 unit.
REASON         Blood product labeled with an extended
               expiration date was distributed.

_______________
PRODUCT        Recovered Plasma.  Recall #B-259-6.
CODE           Unit #39KG28234.
MANUFACTURER   American Red Cross Blood Services, Huntington,
               West Virginia.

                             -6-RECALLED BY    Manufacturer, by letter on April 12, 1994. 
               Firm-initiated recall complete.
DISTRIBUTION   California.
QUANTITY       1 unit.
REASON         Blood product, corresponding to a unit of Red
               Blood Cells contaminated with Staphylococcus
               capitis, was distributed.

_______________
PRODUCT        Source Plasma.  Recall #B-268-6.
CODE           Unit numbers:  G-55818-60, 34469439, 35841043,
               35843917, 41404638, 41405819, 41408513,
               41409688, 41352007, 43360376, 43363254,
               43364435, 43368495, 42939306, 43020454,
               44591588, 44597610.
MANUFACTURER   Sera-Tec Biologicals, Harrisburg,
               Pennsylvania.
RECALLED BY    Manufacturer, by letter dated December 15,
               1994.  Firm-initiated recall complete
DISTRIBUTION   California, Germany.
QUANTITY       17 units. 
REASON         Blood products, collected from donors at
               increased risk for hepatitis or previously
               deferred for epilepsy, were collected.

_______________
PRODUCT        Whole Blood.  Recall #B-285-6.
CODE           Unit #35L07504.
MANUFACTURER   American Red Cross Blood Services, Roanoke,
               Virginia.
RECALLED BY    Manufacturer, by letter dated August 22, 1994. 
               Firm-initiated recall complete.
DISTRIBUTION   Virginia.
QUANTITY       1 unit.
REASON         Autologous blood product, which tested
               reactive for syphilis by Rapid Plasma Reagin
               (RPR), was distributed without a biohazard
               label.

_______________
PRODUCT        Red Blood Cells.  Recall #B-286-6.
CODE           Unit numbers:  KP37942, KP37946, KP37926,
               KQ21616, KQ21655, KQ21678, KQ21631, KH66291,
               KC43001, KE50685, KE50673.
MANUFACTURER   Virginia Blood Services, Richmond, Virginia.
RECALLED BY    Manufacturer, by telephone on or about
               December 25, 1995.  Firm-initiated recall
               complete.
DISTRIBUTION   Virginia.
QUANTITY       11 units.

                             -7-REASON         Red Blood Cells, collected in AS-1,
               anticoagulant/preservative solution, were
               labeled as CPD Red Blood Cells, and
               distributed.

_______________
PRODUCT        Recovered Plasma.  Recall #B-290-6.
CODE           Unit #04E69935.
MANUFACTURER   American Red Cross, Dedham, Massachusetts.
RECALLED BY    Manufacturer, by telephone February 16, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   California.
QUANTITY       1 unit.
REASON         Blood product untested for syphilis was
               distributed.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II ========
_______________
PRODUCT        Air Shields Model 9240 Athena ECG/RESP
               Neonatal Module, Part numbers SW551533 and
               862400.  Recall #Z-484-6.
CODE           All sold prior to January 1995 with software
               version V01.11.  Serial numbers:  10282400,
               10282403, 10282407, 10282412, 10282413,
               10282415, 10282416, 10282418, 10282423,
               10282425, 10283392, 10283398, 10283403,
               10283410, 10283414, 10283423, 10283424,
               10283425, 10283426, 10283430, 10284968,
               10284973, 10284974, 10284975, 10284978,
               10284979, 10284982, 10284985, 10284986,
               10284987, 10284990, 10284991, 10284993,
               10284994, 10284997, 10523750, 10523751,
               10523752, 10523753, 10523755, 10523756,
               10523757, 10523758, 10523760, 10523763,
               10523764, 10523765, 10523768, 10523769,
               10523771, 10523772, 10284999, 10285000,
               10285003, 10285006, 10285007, 10285012,
               10285014, 10285015, 10285017, 10285018,
               10285027, 10285346, 10285349, 10286230,
               10286232, 10286236, 10286239, 10286241,
               10286244, 10286245, 10286247, 10286253,
               10286254, 10286255, 10286256, 10286257,
               10286258, 10286260, 10286261, 10286263,
               10286265, 10286266, 10286267, 10288575,
               10289420, 10523773, 10535020, 10535023,
               10535025, 10535027, 10549165, 10549166,
               10549168, 10549169, 10549170, 10549178,
               10549180, 10549181, 10549186, 10549571,
               10549574, 10294428, 10294430, 10294431,
               10294436, 10294444, 10294445, 10294446, 

                             -8-               10294457, 10294460, 10297310, 10297312,
               10297313, 10297476, 10297477, 10297478,
               10297480, 10297482, 10297484, 10297485,
               10298615, 10298628, 10298630, 10298633,
               10298636, 10298639, 10298640, 10298642,
               10298643, 10298644, 10298645, 10300178,
               10300180, 10300181, 10300183, 10300184,
               10549580, 10549584, 10559619, 10564976,
               10564978, 10565008, 10565009, 10565012,
               10565014, 10565015, 10565038, 10565039,
               10565040, 10565041, 10565042, 10565043,
               10300187, 10301768, 10301769, 10301770, 
               10301772, 10301774, 10301829, 10301830,
               10301946, 10303436, 10303528, 10303531, 
               10303533, 10303534, 10303535, 10303921,
               10303922, 10303923, 10303928, 10303929,
               10303931, 10303936, 10303938, 10304175,
               10304188, 10304191, 10306433, 10306445,
               10306447, 10306448, 10306449, 10306450,
               10306452, 10306456, 10306458, 10565045,
               10565046, 10565047, 10567240, 10569384,
               10569417, 10569431, 10569432, 10569435,
               10569436, 10588073, 10596284, 10596616,
               10596622, 10596623, 10596625, 10306462,
               10307299, 10307302, 10307303, 10307304,
               10307305, 10307309, 10307311, 10309172,
               10309300, 10309301, 10459486, 10459521,
               10459522, 10459525, 10459526, 10459528,
               10459530, 10459531, 10459536, 10459539,
               10460230, 10460232, 10460233, 10460234,
               10460238, 10460241, 10460242, 10460252,
               10460508, 10460512, 10460517, 10460519,
               10468164, 10509846, 10596627, 10596628,
               10596629, 10610654, 10610658, 10610659,
               10610664, 10610665, 10610666, 10610762,
               10610764, 10610765, 10610772, 10610773,
               10610777, 10610778. 
MANUFACTURER   Air Shields, Hatboro, Pennsylvania.
RECALLED BY    Manufacturer, by letter dated November 3,
               1995.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       255 units.
REASON         This model failed to alarm when one of the
               alarm limits had been exceeded.  Investigation
               of this failure revealed the fault was caused
               by a combination of an intermittent, premature
               failure of a component on the processor PCB of
               the ECG/RESP module, and the user's failure to
               follow the recommended start-up procedures for
               the ECG/RESP module as outlined in the
               operator's manual.

                             -9-_______________
PRODUCT        Part A Renasol Acid Concentrate SB-1019,
               hemodialysis concentrate, in 3.43 liter
               bottles.  Recall #Z-491-6.
CODE           11F502 and 59A615.
MANUFACTURER   Minntech Corporation, Plymouth, Minnesota.
RECALLED BY    Manufacturer, by telephone on February 2,
               1996.  Firm-initiated recall complete.
DISTRIBUTION   Massachusetts, Mississippi, Tennessee,
               Wisconsin.
QUANTITY       839 cases (4 bottles per case) were
               distributed.
 REASON        Some bottles of Part A Renasol Acid
               Concentrate SB-1019 are incorrectly labeled as
               SB-1005.  The labeled concentrations of the
               calcium, potassium, and chloride contained
               within the concentrate and dialysate are
               incorrect.

_______________
PRODUCT        CardioGenesis TMR System Model 600 Ho:YAG
               Laser, used in cardiovascular surgery.  
               Recall #Z-493-6.
CODE           Model 600 Ho:YAG Laser.
MANUFACTURER   CardioGenesis Corporation, Santa Clara,
               California.
RECALLED BY    Manufacturer.  FDA approved the firm's
               corrective action plan March 1, 1996.  Firm-
               initiated field correction complete.
DISTRIBUTION   Nationwide.
QUANTITY       6 units.
REASON         The device failed to comply with 21 CFR
               1040.10(f)(5)(ii) in that under certain
               circumstances the emission indicator would not
               be illuminated although the laser could emit a
               beam if the footswitch were depressed.

_______________
PRODUCT        Sonoline Versa Pro Diagnostic Ultrasound
               Imaging Systems with software version 3.2.000. 
               Recall #Z-494-6.
CODE           All units with software version 3.2.000.
MANUFACTURER   Siemens Medical Systems, Inc., Issaquah,
               Washington.
RECALLED BY    Manufacturer, by letter dated December 8,
               1995.  Firm-initiated field correction
               ongoing.
DISTRIBUTION   Nationwide and international.
QUANTITY       46 units were distributed.
REASON         A software design error may lead to
               misdiagnosis resulting in unnecessary invasive
               procedures.

                            -10-_______________
PRODUCT        Reusable Physiological Pressure Transducers,
               Model P23XL MAR/2.  Recall #Z-498-6.
CODE           Unit numbers:  
               10744531  10744532  10744533  10744537
               10744538  10744540  10744545  10744546 
               10744549  10744552  10744553  10744554 
               10744555  10744556  10744558 10744559 
               10744560  10744561  10744562  10744563
               10744564  10744565  10744566  10744567
               10744568  10744569  10744570  10744571 
               10744729  10744747  10744967  10744969 
               10744970  10744975  10744979  10744985
               10744987  10744995  10744998  10745000
               10745449  10745453  10745454  10745465
               10745473  10745479  10745482  10745483
               10745493  10745494  10745501  10745502
               10745548  10745553  10745557  10745567
               10745569  10745576  10745579  10745583
               10745680  10745683  10745698  10745707
               10745752  10745780  10745781  10745785
               10745792  10745800  10748566  10748568 
               10748570  10748571  10748573  10748575
               10748582  10748584  10748590  10748595 
               10748598  10748601.
MANUFACTURER   Ventrex, Inc., Ventura, California.
RECALLED BY    Ohmeda Medical, Inc., Madison, Wisconsin, by
               letter dated December 22, 1995.  Firm-
               initiated recall ongoing.
DISTRIBUTION   Wisconsin, Texas, Georgia.
QUANTITY       88 units.
REASON         Transducers were unable to obtain pressure
               readings.  This was found to be the result of
               a missing jumper wire between pins 4 and 10 in
               the device connector which plugs into a
               monitor.  Without this wire, the Reusable
               Physiological Pressure Transducers will not
               feed data to the monitor and the monitor will
               not acknowledge that the transducer is plugged
               in at all.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III ========
_______________
PRODUCT        Model 437-2 "L" Hex Wrench, used to adjust set
               screws in pulse generator connector assembly. 
               Recall #Z-482-6.
CODE           Lot #J144912.
MANUFACTURER   Pacesetter, Inc., Sylmar, California.
RECALLED BY    Manufacturer, by telephone on December 12,
               1995, and by fax on December 11, 1995.  Firm-
               initiated recall ongoing.

                            -11-DISTRIBUTION   Arkansas, California, Georgia, Illinois, New
               York, Ohio, Pennsylvania, South Carolina,
               Texas, Utah, Virginia, Wisconsin, Japan.
QUANTITY       108 units were distributed.
REASON         Product is not correctly labeled, package is
               labeled as containing size No. 2 wrench, but
               contains size No. 4 wrench.

_______________
PRODUCT        Dade Alcohol and Ammonia Controls, in-vitro
               diagnostic reagent intended to assist in the
               control of precision and accuracy for the
               determination of alcohol and/or ammonia in
               serum or plasma.  Recall #Z-496-6.
CODE           Catalog #B5118, Lot #PAC-37 EXP 6/9/96.
MANUFACTURER   Dade International, Inc., Miami, Florida.
RECALLED BY    Manufacturer, by letter dated December 1995,
               sent on or about December 11, 1995.  Firm-
               initiated recall ongoing.
DISTRIBUTION   Nationwide and international.
QUANTITY       11,515 kits were distributed.
REASON         Incorrect assay value ranges were stated in
               the product insert.

_______________
PRODUCT        Multi-Analyte Calibrator (MAC), for use in the
               aca Discrete Clinical Analyzer.  
               Recall #Z-497-6.
CODE           Catalog #791080901, Lot #M9503.
MANUFACTURER   Dupont Medical Products, Glascow, Delaware.
RECALLED BY    Manufacturer, by letter February 6, 1996. 
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide and international.
QUANTITY       4,422 kits were distributed.
REASON         Kits had a depressed recovery of uric acid in
               the level 3 calibrator.


RECALLS AND FIELD CORRECTIONS:  VETERINARY PRODUCTS -- CLASS II
=========
_______________
PRODUCT        Custom Mix Medicated Feed Containing
               Chlortetracycline, used for the treatment of
               mastitis, 50 g/ton.  Recall #V-008-6.
CODE           None.  Date of Manufacture 12/15/95.
MANUFACTURER   Belmont Mills, Inc., Belmont, Ohio.
RECALLED BY    Manufacturer, by telephone on December 19,
               1995.  Firm-initialed recall ongoing.
DISTRIBUTION   Ohio.
QUANTITY       1,632 pounds were distributed.
REASON         Product is superpotent in Chlortetracycline.

                            -12-_______________
PRODUCT        Warbex Famphur Pour-On for Cattle in 1 gallon
               cans, for grub and lice control.  
               Recall #V-011-6.
CODE           Lot #950661.
MANUFACTURER   PM Resources, Bridgeton, Missouri.
RECALLED BY    Mallinckrodt Veterinary, Inc., Mundelein,
               Illinois, by telephone on January 11, 1996,
               followed by letter January 16, 1996.  Firm-
               initiated recall ongoing.
DISTRIBUTION   Nebraska.
QUANTITY       2,000 1-gallon containers were distributed.
REASON         Product contaminated with isazophos, a turf
               insecticide.


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