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
06/12/1996

ENFORCEMENT REPORT FOR 06/12/1996

June 12, 1996 96-24

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Trader Joe's Imitation Crabmeat, chunks,
individually frozen, packed in 16 ounce clear
plastic bags. Recall #F-495-6.
CODE 60333 60334 60361 60362 60363
60364 60371 60372 60373 60374
60381 60382 60383 60384 60391
60392 60393 60394 60401 60402
60403 60404 60431 60432 60433
60434 60441 60442 60443 60444.
MANUFACTURER Icicle Seafoods, Inc., Bellingham, Washington.
RECALLED BY Manufacturer, by E-mail message sent on March
29, 1996, by letter faxed on April 4, 1996,
and by press release issued by Trader Joe's on
April 5, 1996. Firm-initiated recall
complete.
DISTRIBUTION Washington state, Oregon, California, Arizona,
Nevada.
QUANTITY 37,400 pounds were distributed.
REASON Product contaminated with Listeria
monocytogenes.

_______________
PRODUCT Holmes brand Canned Sardines in mustard sauce,
in 3.75 ounce cans. Recall #F-568-6.
CODE Codes B2JM2, B2JM3, B3FL1, and B2JL2, are
embossed on one end of the cans.
MANUFACTURER Port Clyde Canning Company, Rockland, Maine.
RECALLED BY Connors Brothers Ltd., Black Harbour, New
Brunswick, Canada, by telephone on or about
February 26, 1996. Port Clyde Canning Co.
issued press release on May 8, 1996. Ongoing
recall resulted from sample analysis and
followup by FDA.
DISTRIBUTION Ohio, Connecticut, Massachusetts.
QUANTITY 305 cases (50 cans per case were distributed).
REASON The product, canned sardines in mustard sauce,
has the potential to support the growth of
Clostridium botulinum toxin.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Pickles Plus "Fresh from the barrel" Dill
Pickles, packaged in 4 gallon plastic
containers. Recall #F-570-6.
CODE None.
MANUFACTURER Home Made Pickle Works, Inc., doing business
as Pickles Plus, Bronx, New York.
RECALLED BY Manufacturer, by telephone the week of April
22, 1996. Ongoing recall resulted from sample
analysis and followup by the New York State
Department of Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY Approximately 56 4-gallon containers were
distributed.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Soft Drinks in 12 ounce cans:
(a) Pepsi in red, white, and blue, cans; (b)
Strawberry Slice in black, white, pink, and
green cans. Recall #F-572/573-6.
CODE All Pepsi and Strawberry Slice manufactured
from 1800 hours 7/11/95 to 0400 hours 7/12/95,
represented by the following codes printed on
the bottom of the cans in blue ink:
1800FW071154 to 2359FW071154 and 0000FW071254
to 0400FW071254.
MANUFACTURER Pepsi Cola Company, Somers, New York.
RECALLED BY Pepsi-Cola of Torrance, Torrance, California,
verbally on July 28, 1995 and by interoffice
memorandum on July 31, 1995, followed by
visit. Firm also issued a press release on
July 31, 1995. Firm-initiated recall
complete.
DISTRIBUTION California.

-2-QUANTITY 8,656 cases (4 6-packs per case) were
distributed.
REASON Products are unfit for food due to metal
fragments.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Real Fresh brand 2% Low Fat Milk, in 32 fluid
ounce cartons. Recall #F-567-6.
CODE RH16CLV2 and RH16CLW2 Best Used 8 SEP 96.
MANUFACTURER Real Fresh, Inc., Visalia, California.
RECALLED BY Manufacturer, by visit beginning on February
28, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates none remains on the market.
REASON The product has an off flavor.

_______________
PRODUCT Lemix brand Sweet and Sour Cocktail Mix in 32
fluid ounce plastic bottles. Recall F-571-6.
CODE All cocktail mix manufactured in April and
May, prior to May 24, 1996.
MANUFACTURER Lemix, Inc., Westlake, Ohio.
RECALLED BY Manufacturer, by letters sent on May 31, 1996,
and June 3, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Ohio, Michigan.
QUANTITY 197 cases (12 bottles per case) were
distributed.
REASON Product contains undeclared FD&C Yellow No. 6.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Genteal Lubricant Eye Drops, OTC, in 0.5 fluid
ounce bottles. Recall #D-153-6.
CODE Lot #52063 EXP 7/97.
MANUFACTURER Ciba Vision Sterile Manufacturing,
Mississauga, Ontario, Canada.
Orlana Group [aka Marco Sales], North Yourk,
Ontario, Canada (shipper).
RECALLED BY Supreme Distributors Company, Southfield,
Michigan, by telephone, mail, or fax on May
31, 1996 and June 3, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, California, Michigan, Maryland,
Tennessee, Illinois.
QUANTITY 205 cases (24 bottles per case) were
distributed.
REASON Unauthorized distribution of a validation lot
scheduled for destruction.

-3-_______________
UPDATE Recall #D-143-6, Puritan Bennett Carbon
Dioxide, USP, 99%, which appeared in the May
29, 1996 Enforcement Report should read lot #
AB20D56 instead of AB02D56.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Nitrostat Sublingual Tablets (Nitroglycerin
Tablets, USP), 0.4 mg, in bottles of 25 and
100, indicated for the prophylaxis and
treatment of patients with angina pectoris.
Recall #D-149-6.
CODE Lot numbers: 03564F EXP 5/96, 00184F EXP
7/96, 00284F EXP 7/96, 111N4F EXP 11/96.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis Division of Warner Lambert
Company, Morris Plain, New Jersey, by letter
mailed on May 3, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24,257 bottles of 100 tablets and 70,115
bottles of 25 tablets were distributed.
REASON Potency not assured through expiration date.

_______________
PRODUCT Acetaminophen and Codeine Phosphate Oral
Solution, USP, in 5 ml unit dose cups.
Recall #D-151-6.
CODE Lot #5J48 EXP 10/97.
MANUFACTURER Pharmaceutical Associates, Inc., Greenville,
South Carolina.
RECALLED BY Manufacturer, by telephone on February 7,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 255.5 cases (10 trays per case - 10 5-ml cups
per tray) were distributed.
REASON Some trays were mislabeled as to unit dose
volume. Unit dose cups correctly labeled.

_______________
PRODUCT Cheetah Barium Sulfate Suspension, in 250,
450 ml, and 1900 ml bottles, used for gastro
intestinal tomography. Recall #D-152-6.
CODE Catalog #169708 24/250 ml bottles per case
Catalog #169715 24/450 ml bottles per case
Catalog #169764 4/1900 ml bottles per case
Lot numbers "50502" through "51102". Lot
numbers are printed on caps of 250 & 450 ml.
and on side label of 1900 ml bottles.
-4- 250 ml bottles: 50502, 50503, 50703, 50902.
450 ml bottles: 50504, 50628, 50678, 50731,
50823, 50902, 50925, 50937, 51024, 51023, and
51102.
1900 ml bottles: 50703, 50768, 50823, 50860,
and 51001.
MANUFACTURER Lafayette Pharmaceuticals, Inc., Lafayette,
Indiana.
RECALLED BY Manufacturer, by telephone during the week of
May 7-9, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide
QUANTITY Approximately 166,000 units were distributed.
REASON Presence of mold in some units.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets, Pheresis. Recall #B-223-6.
CODE Unit #Q02057.
MANUFACTURER Central California Blood Center, Fresno,
California.
RECALLED BY Manufacturer, by letter dated October 18,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had
traveled to an area designated as endemic for
malaria, was distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-224/226-6.
CODE Unit #39-42032.
MANUFACTURER Michigan Community Blood Center, Grand Rapids,
Michigan.
RECALLED BY Manufacturer notified the consignees on
October 26, 1994. Firm-initiated recall
complete.
DISTRIBUTION Michigan, California.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor with a
history of nose piercing, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Recovered Plasma; (f) Platelets, for further
manufacture. Recall #B-396/401-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1191 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Rochester,
New York.
-5-RECALLED BY Manufacturer, by letters dated October 24,
1995, and February 12 and 13, 1996, and by
letters from October 30, 1995 through April
19, 1996. Firm-initiated recall ongoing.
DISTRIBUTION New York, Pennsylvania, California,
Switzerland.
QUANTITY (a) 32 units; (b) 20 units; (c) 3 units; (d) 9
units; (e) 26 units; (f) 2 units.
REASON Blood products, which tested repeatedly
reactive for antibody to the human
immunodeficiency virus type 1 (anti-HIV-1), or
which tested negative for anti-HIV-1, but were
collected from donors who previously tested
repeatedly reactive for anti-HIV-1, were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Whole Blood; (c)
Fresh Frozen Plasma; (d) Recovered Plasma.
Recall #B-406/409-6.
CODE Unit numbers: (a) 31C53066, 31K84967,
31R37590, 31R38484, 31X02539; (b) 31H67665;
(c) 31X02539; (d) 31C53066, 31H67665,
31R37590, 31R38484, 31K84967.
MANUFACTURER American Red Cross, Buffalo, New York.
RECALLED BY American Red Cross, Rochester, New York, by
letter dated October 25, 1995. Firm-initiated
recall complete.
DISTRIBUTION New York, Ohio, California, Switzerland.
QUANTITY (a) 5 units; (b) 1 unit; (c) 1 unit; (d) 5
units.
REASON Blood products, collected from donors who
tested repeat reactive for HBsAg and were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Platelets. Recall #B-430/432-6.
CODE Unit #38FN97046.
MANUFACTURER American Red Cross, Ft. Wayne, Indiana.
RECALLED BY Manufacturer, by letter dated October 20,
1995. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who
traveled to areas designated as endemic to
malaria, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-441-6.
CODE Unit #S04490923.

-6-MANUFACTURER BloodCare, also known as J.K. & Susie L.
Wadley Research Institute & Blood Bank,
Dallas, Texas.
RECALLED BY Manufacturer, by letter dated August 23, 1995.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, collected from a donor exposed
to hepatitis, was distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-443-6.
CODE Unit numbers: 15KJ05603 and 15KJ06802.
MANUFACTURER American Red Cross Blood Services, Missoula,
Montana.
RECALLED BY Manufacturer, by letters dated May 25, 1995.
Firm-initiated recall complete.
DISTRIBUTION Michigan, Montana.
QUANTITY 2 units.
REASON Blood products, which were collected from a
donor who had traveled to an area considered
endemic for malaria within one year of
donation, were distributed.

_______________
PRODUCT Alphanate brand Antihemophilic Factor (Human),
Factor VIII. Recall #B-455-6.
CODE Lot #AP5015A.
MANUFACTURER Alpha Therapeutic Corporation, Los Angeles,
California.
RECALLED BY Manufacturer, by letter on May 1, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION California, Illinois, Pennsylvania, New York,
Tennessee.
QUANTITY 1,169 units were distributed.
REASON Factor VIII product may contain Hepatitis A
virus (HAV), was distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets, Pheresis. Recall #B-425-6.
CODE Unit numbers: 02P04307, 02P04310, 02P04312.
MANUFACTURER American Red Cross Blood Services, Wichita,
Kansas.
RECALLED BY Manufacturer, by telephone on July 21, 1995,
followed by letters dated July 27, 1995, and
by telephone on August 18, 1995, followed by
letter dated August 21, 1995. Firm-initiated
recall complete.
DISTRIBUTION Kansas.
QUANTITY 3 units.

-7-REASON Blood products, which were not subjected to
continuous agitation during storage and for
which the storage temperature was not
monitored, were distributed.

_______________
PRODUCT Fresh Frozen Plasma, Cryoprecipitated AHF.
Recall #B-436/437-6.
CODE Unit numbers: (a) 10498-0499, 10498-8015,
10498-9037, 17177-8663, 17177-8665,
23131-5972, 23131-6242, 23131-6263,
23131-6274, 23131-6339, 23131-6340,
23131-6341, 23131-6435, 23131-6437,
23131-6443, 23131-6444, 23131-6456,
23131-6458, 23131-6525, 23131-6574,
23131-6581, 23131-6585
(b) 19224-8629, 19224-8662, 19224-8670,
19224-8938, 19225-0494, 19225-1041,
19225-1363, 19225-1383, 21358-7751.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc. doing business as United
Blood Services, Scottsdale, Arizona, by
telephone on September 27, 1995, followed by
letter dated September 29, 1995. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY (a) 22 units; (b) 9 units.
REASON Blood products, which were exposed to
unacceptable temperatures, were distributed.

_______________
PRODUCT Forma Scientific - Temperature Controls on
Laboratory and Platelet Incubators, and Plasma
Thawing Baths. Recall #B-442-6.
CODE Laboratory Incubators: 546, 1025 (anaerobic),
1029 (anaerobic), 1031 (anaerobic), 1037
(anaerobic), 3154, 3158, 3159, 3164, 3165,
3166, 3173, 3179, 3187, 3192, 3315, 3319,
3326, 3327, 3332, 3336, 3337, 3342, 3354,
3546, 3548.
Platelet Storage Incubators: 3603, 3606,
3609, 3612.
Plasma Thawing Bath: 2032.
MANUFACTURER Forma Scientific, Inc., Marietta, Ohio.
RECALLED BY Manufacturer, by letters during the period
February 13-24, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 14,799 temperature controls were distributed.

-8-REASON Forma Scientific determined that the 8200 ohm
carbon composition resistor used in units
manufactured between May 13, 1989 and July 31,
1993 may degrade after two years.

_______________
UPDATE Recall #B-392-6, Gammar-P.I.V., Immune
Globulin Intravenous (Human), manufactured by
Centeon, A Company of Armour and Behring,
Bradley, Illinois, which appeared in the May
8, 1996 Enforcement Report has been
reclassified as a Class III recall.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Siemens 800 Series Gas Column Cleat
Assemblies, used with Siemens Ceiling Stands
800, 810, and 800F for mounting the Sirecust
1280/1281 and Sirecust 960/961 (patient
monitors) in positioning monitors for constant
observation in the OR. Recall #Z-483-6.
CODE Siemens 800 series gas column cleat assemblies
with cleats made of composite material only,
and a length greater than 9 inches.
MANUFACTURER Siemens Medical Systems, Inc., Danvers,
Massachusetts.
RECALLED BY Manufacturer, by letter on December 8, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 157 units were distributed.
REASON Cleat assemblies were found to be manufactured
from out-of-spec material. There is a
potential that the cleat assemblies could
separate from the support boxes and cause the
cleat assembly and supported device to fall.

_______________
PRODUCT TV Monitor Suspension, Model 46-240838G2, a
support for a TV monitor used with Advantx RFX
R&F X-ray equipment. Recall #Z-868-6.
CODE All model 46-240838G2 suspensions manufactured
before 3/8/95.
MANUFACTURER GE Medical Systems S.A., Buc Cedex, France.
RECALLED BY General Electric Company, Medical Systems
Division, Waukesha, Wisconsin, by issuing
field modification instructions on May 10,
1995. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 33 units were distributed. All units have been
corrected.

-9-REASON The pivot support screw of a TV monitor
suspension can become loose allowing the TV
monitor to fall.

_______________
PRODUCT 80 Tube Stand, Model 46-162705P1, used with
Monitrol 15 or 73 Horizontal X-ray tables.
Recall #Z-869-6.
CODE All units.
MANUFACTURER GE Medical Systems S.A., Buc Cedex, France.
RECALLED BY General Electric Company, Medical Systems
Division, Waukesha, Wisconsin, by issuing
field modification instructions on January 3,
1996. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 116 units were distributed. All units have
been corrected.
REASON The main cable of the tube stand can rupture
and the safety mechanism fail to actuate,
allowing the collimator to fall onto the table
top.

_______________
PRODUCT Advantx AFM Angio System, Model No. 4551600,
x-ray device for medical imaging during
general angiography and interventional
procedures. Recall #Z-870-6.
CODE Serial numbers: 37950BU3, 38723BU3, 38724BU1,
40444BU2, 41662BU8, 44023BU0, 44769BU8,
44770BU6, and 45367BU0.
MANUFACTURER GE Medical Systems, S.A., Buc Cedex, France.
RECALLED BY General Electric Company, Medical Systems
Division, Waukesha, Wisconsin, by issuing
field modification instructions on December
11, 1995. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.d
QUANTITY 7 units were distributed. All units have been
corrected.
REASON There is a risk of unintended motions and loss
of collision sensors that can result in injury
to the patient or user.

_______________
PRODUCT Disposable Umbilical Cord Cutter and Shield,
Catalog #DUCS/CRD-100, may be used after
delivery of the fetus, while the mother and
child are still attached by the umbilical
cord, but blood flow is clamped off.
Recall #Z-873-6.
CODE Lot numbers 40323 and 40837.
MANUFACTURER Foremed, Chonbuk, Korea.
-10-RECALLED BY Utah Medical Products, Inc., Midvale, Utah, by
letter on August 3, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,521 units were distributed; firm estimates
none remains on the market.
REASON Sterility may be compromised due to a
defective packaging seal.

_______________
PRODUCT Biad Whole Body SPECT Nuclear Imaging Systems,
BIAD 89 Dual Headed Camera, used mainly for
whole body imaging, cardiac, renal, brain and
bone scans. Recall #Z-874-6.
CODE All units.
MANUFACTURER Trionix Research Laboratory, Inc., Twinsburg,
Ohio.
RECALLED BY Manufacturer, by telephone from April 29, 1996
through May 1, 1996. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 81 systems were distributed.
REASON The detector head has the potential to fall
during a scanning procedure, which can result
in injury to the patient or user.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Cardiofocal Collimator System, designed for
use with Integrated and Analog Orbiter,
Diacam, Multispect 2 and Multispect 3 Gamma
Camera Systems to conduct cardiac SPECT
studies utilizing Technetium and Thallium
radionuclides. Recall #Z-852-6.
CODE Orbiter Systems - all units assembled with
Cardiofocal collimators prior to 8/8/95.
Diacam, Multispect 2 and Multispect 3 Systems
- all units assembled with Cardiofocal
collimators prior to 8/9/95.
MANUFACTURER Siemens Medical Systems, Inc. Nuclear Medicine
Group, Hoffman Estates, Illinois.
RECALLED BY Manufacturer, by letter dated March 28, 1995,
and by initiating a Mandatory Immediate Field
Modification Instruction (FMI-00165) on
September 1, 1995. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 66 units were distributed.
REASON The gamma camera systems did not have adequate
instructions and positioning aids to assure
that the patient's heart was centered for
Cardiofocal scans.
-11-_______________
PRODUCT Cardiofocal and/or Fan Beam Collimator Systems
used with Multispect 2 and Multispect 3 Gamma
Cameras shipped prior to 7/14/95:
(a) Kit 2995897; Cardiofocal Collimator Set
for Multispect 3;
(b) Kit 3567372; Multispect 3 Cardiofocal
Collimator Set w/Ultra High Sens, w/o Phantom;
(c) Kit 3567380; Multispect 3 Fan Beam
Collimator Set w/o Phantom;
(d) Kit 3567406; Multispect 2 Cardiofocal Set
(1 Cardiofocal, 1 LEHR collimator) w/o
Phantom;
(e) Kit 3567414; Multispect 2 Foil Fan Beam
Set (2 fan beam collimators) w/o Phantom;
(f) Kit 3567356; Set Cardiofocal Collimator
for M3 w/o Phantom;
(g) Kit 3567364; Multispect 3 High
Res/Cardiofocal Collimator Set w/o Phantom;
(h) Kit 3567398; Set Cardiofocal Collimator
for M2 w/o Phantom. Recall #Z-875/882-6.
CODE All Multispect 2 and Multispect 3 Gamma
Cameras with Cardiofocal and/or Fan Beam
Collimators shipped prior to 7/14/95.
MANUFACTURER Siemens Medical Systems, Inc., Nuclear
Medicine Group, Hoffman Estates, Illinois.
RECALLED BY Manufacturer, by initiating a Mandatory
Immediate Field Modification Instruction (FMI-
00160) on July 14, 1995. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide, Germany, Belgium, Switzerland,
Colombia.
QUANTITY 38 units required manuals and were corrected
as of May 11, 1996.
REASON The kits did not include all of the operator's
manuals and/or installation procedures.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
========
_______________
PRODUCT SW-SB Basemix Medicated Feed with Apramycin.
Recall #V-018-6.
CODE 182085 and 210375.
MANUFACTURER Precision Microblenders, Inc., Ciales, Puerto
Rico.
RECALLED BY Archer Daniels Midland, Decatur, Illinois, by
telephone and letter Firm-initiated recall
complete.
DISTRIBUTION Puerto Rico.
QUANTITY 4,900 pounds were distributed.
REASON Failure to meet specifications for apramycin
(superpotent).

-12-_______________
PRODUCT Alpo Prime Cuts for Cats: (a) Sliced Beef in
Gravy, in 5.5 ounce cans; (b) Sliced Turkey in
Gravy, in 5.5 ounce cans.
Recall #V-019/020-6.
CODE (a) Product code: 11132-00563
DAY CODES: 6078FW, 6078FW2W, 6078FW2X,
6079FW2A, 6079FW2B, 6079FW2Y, 6079FW2Z
(b) product code: 11132-00564
Day codes: 6078FW2Q, 6078FW2M, 6078FW2N,
6078FW2L, 6079FW1F.
MANUFACTURER Friskies Pet Care, Fort Dodge, Iowa.
RECALLED BY Nestle USA, Inc., Glendale, California, by
letter May 3, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and the Virgin Islands.
QUANTITY (a) 12,544 cases; (b) 8,036 cases were
distributed.
REASON Can seam defect.

-13-

END OF ENFORCEMENT REPORT FOR JUNE 12, 1996. BLANK PAGES MAY FOLLOW.

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