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
07/18/1995
ENFORCEMENT REPORT FOR 07/19/95
July 19, 1995 95-29
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Pyridoxine HCl, 100 mg (Vitamin B-6), in bottles of 210, a
dietary supplement, under the Great Earth label.
Recall #F-683-5.
CODE DEC/97-55594.
MANUFACTURER Phoenix Laboratories, Inc., Hicksville, New York.
RECALLED BY Manufacturer, by letter sent March 24, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY 237 bottles were distributed; firm estimates none remains on
the market.
REASON Niacin tablets were mislabeled as Vitamin B6 Tablets.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Dilantin Kapseals 100 mg (extended Phenytoin Sodium
capsules, USP) in bottles of 100, an anti-epileptic.
Recall #D-210-5.
CODE Lot #064N4FA EXP 10/96.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner Lambert Company, Morris
Plain, New Jersey, by letters mailed between June 23 and 26,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 39,510 bottles were distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Quinidine Sulfate, 200 mg, Immediate Release Tablets, in
bottles of 100, typically prescribed for initial loading
dosage of Quinidine prior to maintenance therapy with
Quinidine Gluconate. Recall #D-211-5.
CODE Lot #30373 EXP 3/97.
MANUFACTURER Mutual Pharmaceutical Company, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by letter dated June 19, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,961 bottles wee distributed.
REASON Product does not meet content uniformity specifications.
_______________
PRODUCT Palgic D Tablets in plastic bottles of 100 with screw on
plastic caps, an antihistamine/decongestant.
Recall #D-212-5.
CODE Lot #SH402CP EXP 8/96.
MANUFACTURER Sage Pharmaceuticals, Inc., Shreveport, Louisiana.
RECALLED BY Manufacturer, by letter June 26, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Louisiana.
QUANTITY 887,400 tablets were distributed.
REASON Product does not meet time release specifications for
pseudoephedrine, HCl ingredient.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Histenol Forte Tablet, an OTC multisymptom cold product,
distributed in bulk containers, and repacked into individual
2 tablet packets. The packets are packaged into cartons
containing 100, 180, 250, or 1,000 packets.
Recall #D-209-5.
CODE Lot numbers: P57 and P58.
MANUFACTURER J.B. Laboratories, Holland, Michigan.
RECALLED BY Manufacturer, by letter May 26, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 200,000 tablets remained on market at
time of recall initiation.
REASON Presence of small amounts of Ephedrine HCl in the
pseudoephedrine HCl raw material.
-2-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-199/200-5.
CODE Unit numbers: 1194301, 1194304, 1194307, 5215275, 7152323.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by letters dated September 3, 1993. Firm-
initiated recall complete.
DISTRIBUTION Texas, Missouri.
QUANTITY 5 units of each component.
REASON Corresponding blood product was contaminated with bacillus
species
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-462/463-5.
CODE Unit #47G90945.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated March 15 and 21, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois, California
QUANTITY 1 unit of each component.
REASON Blood products for which initial reactive test results for
antibody to human immunodeficiency virus type 1 (anti-HIV-1)
were not repeated in duplicate, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #468-5.
CODE Unit #09J82762.
MANUFACTURER American Red Cross Blood Services, Omaha, Nebraska.
RECALLED BY Manufacturer, by telephone July 11, 1994, followed by letter
dated July 28, 1994. Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit.
REASON Blood product, corresponding to a unit of platelets
contaminated with coagulase negative Staphylococcus, was
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-461-5.
CODE Unit numbers: 13FF20519, 13FF20523, 13FF20589, 13FF20331.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
RECALLED BY Manufacturer, by letters dated February 8, 1995, and March
2, 1995. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 4 units.
REASON Blood components, which were collected in expired blood
collection bags, were distributed.
-3-
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-464/465-5.
CODE Unit numbers: (a) 287539, 485734, 486644, 983458;
(b) 486644.
MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas.
RECALLED BY Manufacturer, by telephone July 26, 1994 or October 5, 1994,
or by letters dated July 27, 1994. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY (a) 4 units; (b) 1 unit.
REASON Blood products, which tested reactive for syphilis by the
Rapid Plasma Reagin assay (RPR), were distributed.
_______________
PRODUCT Platelets. Recall #B-466-5.
CODE Unit #575366.
MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas.
RECALLED BY Manufacturer, by telephone September 16, 1994. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for the
antibody to the hepatitis B core antigen (anti-HBc), were
distributed.
_______________
PRODUCT Anti-Lewisa Blood Grouping Reagent. Recall #B-467-5.
CODE Lot numbers: 2347, 2348, 2349.
MANUFACTURER Organon Teknika Corporation, West Chester, Pennsylvania.
RECALLED BY Organon Teknika Corporation, Durham, North Carolina, by
letters dated February 6 and 10, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 340 units of lot 2347, 1,390 units of lot 2348, 408 units of
lot 2349 were distributed.
REASON Anti-Lewisa (anti-Lea) Blood Grouping Reagent, which was
packaged with a product insert containing an incorrect
procedure for use, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Devices labeled as Selector Catheters, 100 cm, 5 French,
Left Coronary Bypass, Catalog #445.0-062. Recall #Z-759-5.
CODE Lot numbers: 14058, 14274.
MANUFACTURER NAMIC Caribe, Inc., Aguadilla, Puerto Rico.
RECALLED BY NAMIC U.S.A. Corporation, Glens Falls, New York, by
telephone April 18 & 19, 1995, followed by letter dated
April 18, 1995. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Iowa, Illinois, Maryland, Missouri,
Michigan Nebraska, New York, Washington State, Ireland.
QUANTITY 118 units were distributed
-4-
REASON Mislabeled. Packages labeled as Selector Catheters, 100 cm,
5 French, Left Coronary Bypass, contains an Amplatz Left 1.5
catheter.
_______________
PRODUCT Baxter Flow-Through Injectable Housing, Sterile, Model 93-
505, when used in conjunction with a Baxter temperature
probe, is a flow-through housing which allows direct
temperature measurement of the thermal indicator at the
proximal lumen infusion site. Recall #Z-848-5.
CODE Lot numbers: 4V07F-3960, 4W07F-0037.
MANUFACTURER Baxter Healthcare Corporation of Puerto Rico, Anasco, Puerto
Rico.
RECALLED BY Baxter Healthcare Corporation, Irvine, California, by
letters dated March 16 and 17, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Arkansas, California, Colorado, Florida, Hawaii, Idaho,
Kansas, Massachusetts, Maryland, Minnesota, North Carolina,
North Dakota, New York, Pennsylvania, Virginia, Wisconsin,
and international.
QUANTITY 3,072 units were distributed.
REASON The lots were found to have inadequate package seals which
may compromise the sterility of the device.
_______________
PRODUCT USCI 5F Envision Angiographic Catheters, intravascular
diagnostic catheters used to record intracardiac pressures
to sample blood and to introduce substances into the heart
and vessels. Recall #Z-857-5.
CODE All units manufactured through 12/16/95. Item numbers:
Item No. Description
051000 Straight Pigtail
051001 145 degree Pigtail
051002 155 degree Pigtail
051003 JL 3.5
051004 JL 4.0
051005 JL 5.0
051006 JL 6.0
051007 No Torque Right
051008 JR 3.5
051009 JR 4.0
051010 JR 5.0
051011 JR 6.0
051012 Champ 0.5
051013 Champ 1.0
051015 Amplatz Right 1
051016 Amplatz Right 2
051017 Amplatz Left 1
051018 Amplatz Left 2
051019 Amplatz Left 3
051020 Multipurpose A-1
051021 Multipurpose A-2
-5-
051022 Multipurpose B-1
051023 Multipurpose B-2
051024 Coronary Bypass
051025 Coronary Bypass
051026 Internal mammary
051027 Sones A
051028 Sones B
051029 Sones C
051030 Brachial 3.5
051031 Brachial 4.0
051032 Brachial 4.5
051033 155 degree Pigtail
051034 Tight Radius Straight Pigtail
051035 Tight Radius 145 degree Angle
051037 Champ 3.0
051038 Champ 3.5
051043 Modified JR 4.0
355050 EZ Pak w/.035"wire and Straight
Pigtail
355051 EZ Pak w/.035" wire and 145 degree
angle Pigtail
355052 EZ Pak w/.035" wire and 155 degree
angle Pigtail
385050 EZ Pak w/.038" wire and Straight
Pigtail
385051 EZ Pak w/.035" wire and 145 degree
angle Pigtail
385052 EZ Pak w/.038" wire and 155 degree
angle Pigtail
551050 Angio Kit with Straight Pigtail
551051 Angio Kit with 145 degree Angle
Pigtail
551052 Angio Kit with 155 degree Angle
Pigtail.
MANUFACTURER USCI Manufacturing Facility, Billerica, Massachusetts.
RECALLED BY USCI Division, C.R. Bard, Inc., Billerica, Massachusetts, by
letter January 6, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 15,020 units were distributed.
REASON The tip segment separates from the proximal shaft.
_______________
PRODUCT USCI 5F Envision Angiographic Catheters, intravascular
diagnostic catheters used to record intracardiac pressures
to sample blood and to introduce substances into the heart
and vessels. Recall #Z-858-5.
CODE All units manufactured from 12/16/94 - 5/12/95.
Item No. Description
051000 Straight Pigtail
051001 145 degree Pigtail
051002 155 degree Pigtail
051003 JL 3.5
-6-
051004 JL 4.0
051005 JL 5.0
051006 JL 6.0
051007 No Torque Right
051008 JR 3.5
051009 JR 4.0
051010 JR 5.0
051011 JR 6.0
051012 Champ 0.5
051013 Champ 1.0
051015 Amplatz Right 1
051016 Amplatz Right 2
051017 Amplatz Left 1
051018 Amplatz Left 2
051019 Amplatz Left 3
051020 Multipurpose A-1
051021 Multipurpose A-2
051022 Multipurpose B-1
051023 Multipurpose B-2
051024 Coronary Bypass
051025 Coronary Bypass
051026 Internal mammary
051027 Sones A
051028 Sones B
051029 Sones C
051030 Brachial 3.5
051031 Brachial 4.0
051032 Brachial 4.5
051033 155 degree Pigtail
051034 Tight Radius Straight Pigtail
051035 Tight Radius 145 degree Angle
051037 Champ 3.0
051038 Champ 3.5
051043 Modified JR 4.0
355050 EZ Pak w/.035"wire and Straight
Pigtail
355051 EZ Pak w/.035" wire and 145 degree
angle Pigtail
355052 EZ Pak w/.035" wire and 155 degree
angle Pigtail
385050 EZ Pak w/.038" wire and Straight
Pigtail
385051 EZ Pak w/.035" wire and 145 degree
angle Pigtail
385052 EZ Pak w/.038" wire and 155 degree
angle Pigtail
551050 Angio Kit with Straight Pigtail
551051 Angio Kit with 145 degree Angle
Pigtail
551052 Angio Kit with 155 degree Angle
Pigtail.
-7-
MANUFACTURER USCI Manufacturing Facility, Billerica, Massachusetts.
RECALLED BY USCI Division, C.R. Bard, Inc., Billerica, Massachusetts, by
letter May 23, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 7,140 units were distributed.
REASON Pinhole defects were found in the pigtail catheters.
_______________
PRODUCT Orthodontic wire distal-end mini cutter used by
dentists/orthodontists, to cut different sizes of dental
braces wire material inside the patient's mouth:
(a) Model AEZ Part #803-0510, Ezcurra Distal Cutter with
hold long handle; (b) Model AEZ Part 803-0511, Ezcurra
Distal End Cutter with hold short handle.
Recall #Z-868/869-5.
CODE Batch numbers: 2xxx, 3xxx, 4Axx, 4Bxx, 4Cxx, 4Dxx, 4Exx,
4Fxx, 4Gxx, 4Hxx (where the x represents any letter or
number). There are no serial numbers or expiration/use-by
dates.
MANUFACTURER ORMCO Corporation, Glendora, California.
RECALLED BY Manufacturer, by letters dated May 5 and 11, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 5,700 cutters were distributed.
REASON The device's tip could break in patient's mouth.
_______________
PRODUCT Nuclear Imaging Systems: (a) Model 1000S; (b) Model 2000S;
(c) Model 1000XP; (d) Mode 2000XP. Recall #Z-939/942-5.
CODE All serial numbers.
MANUFACTURER Ohio Imaging Nuclear Medicine Division, Picker
International, Bedford Heights, Ohio.
RECALLED BY Manufacturer, by letter February 1, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 252 units were distributed.
REASON The camera's detector head may drift beyond acceptable
limits which will result in a high force being placed
against the patient's head or body.
_______________
PRODUCT Endoscope Reprocessor (Ultrasonic Washer):
(a) System 83; (b) System 83 Plus. Recall #Z-958/959-5.
CODE All product manufactured before 1/92 when a design change
was introduced. All units with serial numbers in which the
last two digits are lower than 92.
MANUFACTURER Custom Ultrasonics, Inc., Ivyland, Pennsylvania.
RECALLED BY Manufacturer, by memorandum dated April 7, 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1,200 units were distributed.
-8-
REASON Device failed to adequately clean the inner channels of the
reprocessed endoscope, resulting in contaminated endoscopes.
_______________
PRODUCT Sterile Non-Latex Surgical Gloves, indicated for use by
surgeons as infection barriers during surgical procedures:
(a) Tactyl 1, Catalog #41070; (b) Tactyl 2, Catalog #51070;
(c) Tactylon, Catalog #51175. Recall #Z-960/962-5.
CODE Lot numbers: (a) 5024-0005; (b) 5024-0003; (c) 5054-0002,
5024-0002.
MANUFACTURER Tactyl Technologies, Inc., Vista, California.
RECALLED BY Manufacturer, by letter March 21, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona, France, Sweden.
QUANTITY 292 shipping cases were distributed; firm estimated that on
April 14, 1995 35 shipping cases remained on the market.
REASON The gloves did not receive the full irradiation dose,
thereby compromising the sterility of the gloves.
_______________
PRODUCT Green Maxon Absorbable Sutures, Size 01 (sterile), indicated
for use in all types of soft tissue approximation, but not
in cardiovascular, ophthalmic or microsurgery and not in
neural tissue. Recall #Z-963-5.
CODE Product #6315-72, Lot numbers: 878309 EXP 9/95, 878308 EXP
10/95.
MANUFACTURER Davis & Geck, Manati, Puerto Rico.
RECALLED BY Davis & Geck, Danbury, Connecticut, by letter June 8, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 183 boxes (24 units per box) were distributed; firm
estimates none remains on the market.
REASON The sutures exhibit low out of package tensile strength.
_______________
PRODUCT Davis & Geck LAPRO-CLIP Ligating Clip Remover (non-sterile).
Recall #Z-964-5.
CODE Product #8487-99, lot numbers: 891890, 892262, 892381,
893528.
MANUFACTURER Mediscope Manufacturing, Inc., North Bergen, New Jersey
(contract manufacturer).
RECALLED BY Davis & Geck, Danbury, Connecticut, by letters sent June 2,
1995. Firm-initiated recall ongoing.
DISTRIBUTION California, Georgia, Illinois, North Carolina, Louisiana,
Massachusetts.
QUANTITY 26 units were distributed; firm estimated that 20 devices
remained in the field at time of recall initiation.
REASON The grasping hook of the device may break and become
detached from the device.
-9-
_______________
PRODUCT Philips Medical Systems SL Series Multi Energy Radiotherapy
Systems. Recall #Z-987-5.
CODE Serial numbers 5001 to 5280.
MANUFACTURER Philips Medical Systems Radiotherapy, West Sussex, England.
RECALLED BY Philips Medical Systems North America Company, Shelton,
Connecticut, by visit after February 1994. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 82 systems were distributed.
REASON There is a potential for a 10 second delay in the "No Dose
Interlock" mode if the ion chamber -300 volt supply fails,
which could continue radiation for an extra 10 seconds.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Lithium Serum Flame Standard for Flame Photometer.
Recall #Z-965-5.
CODE Lot #DB-1.
MANUFACTURER Radiometer Copenhagen, Copenhagen, Denmark.
RECALLED BY Radiometer America, Westlake, Ohio, by telephone on or about
December 7, 1993. Firm-initiated recall complete.
DISTRIBUTION Maine, Illinois, Oregon.
QUANTITY 8 bottles were distributed.
REASON The standard has a lithium content that is lower than the
specified nominal value. This can cause the lithium reading
to be higher than the nominal variation allowed.
_______________
PRODUCT Qualicheck 3 Quality Control Material for ABL-520, control
system designed to monitor the accuracy of pH, blood gas,
and oximetry measurements in the analyzer. Recall #Z-966-5.
CODE Lot #44.
MANUFACTURER Radiometer A/S EmdruppvJ 72, Copenhagen NV, Denmark.
RECALLED BY Radiometer America, Westlake, Ohio, by letter October 28,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 156 boxes were distributed; firm estimates none remains on
the market.
REASON The MetHb (Methemoglobin) value for the material was outside
the stated control range. The actual value was higher than
the stated value.
_______________
PRODUCT Qualicheck 4 Material for ABL-505, a quality control
standard for pH, blood gases, and electrolytes.
Recall #Z-967-5.
CODE Lot #27.
MANUFACTURER Radiometer A/S Emdruppvej 72, Copenhagen NV, Denmark.
RECALLED BY Radiometer America, Westlake, Ohio, by letter August 6,
1993. Firm-initiated recall complete.
-10-
DISTRIBUTION California and Texas.
QUANTITY 13 boxes were distributed; firm estimates none remains on
the market.
REASON The potassium value is lower than labeled.
_______________
PRODUCT Dader Thromboplastin-IS (TPS), in-vitro diagnostic product
for use in prothrombin time (PT) determination and
prothrombin time based assays. Recall #Z-968/973-5.
CODE Catalog No. B4213-20, Lot Nos. TPS-75, TPS-80, TPS-82;
Catalog No. B4213-50, Lot Nos. TPS-77, TPS-79, TPS-79Z,
TPS-81,TPS-86;
Catalog No. B4213-100, Lot No. TPS-74;
Catalog No. 281052, Lot Nos. TPS-82, TPS-87;
Catalog No. 281053, Lot Nos. TPS-75, TPS-77, TPS-79,
TPS-81, TPS-86;
Catalog No. 281054, Lot No. TPS-74.
MANUFACTURER Dade International of Puerto Rico, Aguada, Puerto Rico.
RECALLED BY Dade International, Inc., Miami, Florida, by letter dated
May 1995, and by Fax to international distributors.
DISTRIBUTION Nationwide and international.
QUANTITY 44,161 packages.
REASON The device fails to meet the labeled stability claim after
reconstitution when incubated.
_______________
PRODUCT Dade Thromboplastin-IS (TPS), in-vitro diagnostic product
for use in prothrombin time (PT) determination and
prothrombin time based assays. Recall #Z-974/979-5.
CODE Catalog No. B4213-100, Lot No. TPS-64;
Catalog No. 281054, Lot Nos. TPS-64, TPS-68, TPS-73, TPS-78;
Catalog No. B4213-50, Lot No. TPS-67;
Catalog No. 281053, Lot No. TPS-67;
Catalog No. 281052, Lot No. TPS-70;
Catalog No. B4213-20, Lot No. TPS-84.
MANUFACTURER Dade International of Puerto Rico, Aguada, Puerto Rico.
RECALLED BY Dade International, Inc., Miami, Florida, by letter dated
June 1995, and by fax to international distributors.
DISTRIBUTION Nationwide, Canada, Mexico, Costa Rica, Chile, Colombia,
Japan.
QUANTITY 23,576 packages were distributed.
REASON The device fails to meet the labeled stability claim after
reconstitution when incubated.
_______________
PRODUCT Olympic EVIS Video Endoscopes, used for endoscopic diagnosis
and treatment within the lower digestive tract (colon and
rectum): (a) Model PCF-130I; (b) Model PCF-130L.
Recall #Z-988/989-5.
CODE Lot numbers D & G.
MANUFACTURER Olympus Optical Company, Ltd., Tokyo, Japan.
RECALLED BY Olympus America, Inc., Melville, New York, by letter May 24,
1995. Firm-initiated recall ongoing.
-11-
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 37 were distributed.
REASON The video endoscopes are more susceptible to surges of
electrical current due to a manufacturing defect in the
charged coupled device (CCD) chip which will cause the video
endoscopes to lose their images.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Vitamin K Injectable, 100 ml. Recall #V-034-5.
CODE Lot numbers: 3400, 3480, 3558, 3584.
MANUFACTURER GEN/Rx (formerly AVP), Fort Collins, Colorado.
RECALLED BY manufacturer, by letter mailed June 15, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION California, Colorado, Florida, Iowa, Kansas, Missouri,
Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas, South
Carolina, Puerto Rico.
QUANTITY 5,625 units of lot 3400; 3,459 units of lot 3480; 3,601
units of lot 3,558; 3,036 units of lot 3584 were
distributed.
REASON Product failed stability testing, falling below
specifications.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Coop Lamb Creep Feed Medicated packaged in 50 pound bags.
Recall #V-033-5.
CODE G12234 and L17644.
MANUFACTURER Farmland Industries, Inc., Kansas City, Kansas.
RECALLED BY Manufacturer, by telephone January 30-31, 1995. Firm-
initiated recall complete.
DISTRIBUTION Oklahoma, Missouri, Kansas.
QUANTITY 328 bags were distributed.
REASON Superpotent.
-12-
END OF ENFORCEMENT REPORT FOR JULY 19, 1995. BLANK PAGES MAY FOLLOW.
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