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
05/11/1994
Recalls and Field Corrections: Foods -- Class I -- 05/11/1994
May 11, 1994 94-19
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT (a) Satay's Vegetarian Marinade; (b) Gado-Gado Dressing, in
1.5, 8 and 16 ounce jars. Recall #F-392/393-4.
CODE (a) All lots; (b) 407019, 408009, 408030, 409020, 409025,
401022, 401023, 401106, 401113, 410009, 410001.
MANUFACTURER Texas Food Research, Austin, Texas.
RECALLED BY Manufacturer, by letter dated February 8, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 4 cases of 1.5 ounce jars (6 jars per case), 175 cases
of 8 ounce jars (4 jars per case), 8 cases of 16 ounce jars
(12 jars per case); (b) 7 cases 1.5 ounce jars (6 jars per
case), 152 cases 8 ounce jars (4 jars per case).
REASON Product has the potential to support the outgrowth of
Clostridium botulinum toxin.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Rugby brand: (a) Tri-Statin II Cream (Nystatin and
Triamcinolone Acetonide Cream, USP), in 15 gram tubes, Rx,
for dermatologic use; (b) Triamcinolone Acetonide Cream, USP
0.025%, in 15 gram tubes, Rx, for dermatological use.
Recall #D-264/265-4.
CODE Lot #3K644 EXP 11/95.
MANUFACTURER NMC Laboratories, Inc., Glendale, New York.
RECALLED BY Manufacturer, by telephone April 10, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION 1 wholesale account in New York.
QUANTITY 8,870 tubes were distributed.
REASON A portion of the lot of Tri-Statin II Cream (Nystatin &
Triamcinolone Acetonide) tubes were miscartoned as
Triamcinolone Acetonide Cream.
_______________
PRODUCT Rx oral suspension antibiotics used for the treatment of
respiratory infections, relabeled by Allscrips:
(a) Ceclor Cefaclor Oral Suspension --
125 mg/5 ml, in 75 ml, 150 ml bottles;
187 mg/5 ml, in 50 ml and 100 ml bottles;
250 mg/5 ml, in 75 ml bottles and 150 ml bottles,
375 mg/5 ml, in 50 ml bottles and 100 ml bottles,
(b) Lorabid Loracarbef for Oral Suspension --
100 mg/5 ml, in 50 ml bottles and 100 ml bottles;
200 mg/5 ml, in 50 ml bottles and 100 ml bottles;
(c) Keflex Cephalexin Oral Suspension, Manufactured by Dista
Products Co., Carolina, Puerto Rico --
250 mg/5 ml, in 100 ml bottles and 200 ml bottles.
Recall #D-267/273-4.
CODE All unexpired lots.
MANUFACTURER (a&b) Eli Lilly Industries, Inc., Carolina, Puerto Rico
(responsible firm); (c) Dista Products Company, Carolina,
Puerto.
RECALLED BY Allscrips Pharmaceuticals Inc., Vernon Hills, Illinois
(relabeler), by letter April 1, 1994. Firm-initiated recall
ongoing. See also FDA statement: Recall of Liquid
Antibiotics, dated March 31, 1994.
DISTRIBUTION Nationwide.
QUANTITY (a) 26,898 bottles; (b) 1,190 bottles; (c) 59 bottles were
distributed; firm estimates that 25 percent of the product
remains on the market.
REASON Bottles may contain a small plastic cap.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Sterile Lubraseptic Jelly, in 10 g sterile tubes, non-
prescription product used for lubrication of catheters,
cystoscopes, instruments, and gloves, has anesthetic and
antibacterial qualities, under Baker Norton and United
Guardian labels. Recall #D-266-4.
CODE All lots within expiration date. EXP dates range from
5/94 - 11/98.
MANUFACTURER United Guardian, Hauppauge, New York.
RECALLED BY Manufacturer, by letter April 12, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 43,996 cartons (24 per carton) were distributed.
REASON Subpotency.
-2- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets, Pheresis;
(d) Cryoprecipitated AHF; (e) Red Blood Cells, For Further
Manufacture; (f) Fresh Frozen Plasma; (g) Recovered Plasma.
Recall #B-253/259-4.
CODE Unit numbers: (a) FR32930, FR33173, FR37775, FR38903,
FR39782, GH47903, GH50280, GH57430, GK07162, GK14511,
GM06352, GM16088, GM22426, Q63480, Q66976;
(b) FR32930, FR33173, FR35764, FR38903, FR39782, GH50049,
GH52410, GH54742, GH57430, GM04902, GM14926;
(c) LG02745; (d) FR38903, GK07162, GM19997, Q66976;
(e) Q64223; (f) FR37775, FR39620, FR39782, GK13899, GM06352,
Q64223; (g) FR32930, FR33173, FR35764, FR38903, GH47903,
GH49331, GH50049, GH50280, GH51479, GH52410, GH56633,
GH57430, GK07162, GK14511, GK16905, GK19475, GM04902,
GM14926, GM16088, GM19997, GM22426, LG13705, LJ16704,
Q63480, Q66976.
MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone May 4 and 18, 1993, and by fax
May 19, 1993. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, New York, Illinois, North Carolina,
California.
QUANTITY (a) 15 units; (b) 11 units; (c) 1 unit; (d) 4 units; (e) 1
unit; (f) 6 units; (g) 25 units.
REASON Blood products, which tested negative for the antibody to
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. Recall B-260-4.
CODE Unit #12LH06407.
MANUFACTURER American Red Cross Blood Services, Charlotte, North
Carolina.
RECALLED BY Manufacturer, by telephone September 14, 1993. Firm-
initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product, maintained at improper temperatures during
shipment, was distributed.
_______________
PRODUCT (a) Platelets, Pheresis. Recall #B-267-4.
CODE Unit #C26551.
MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford, Illinois.
RECALLED BY Manufacturer, by telephone October 29, 1993, followed by
letter November 23, 1993. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
-3- REASON Blood product, which tested initially reactive for hepatitis
B surface antigen (HBsAg) followed by a single repeat test,
was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Platelet Concentrate; (b) Platelets, Pheresis.
Recall #B-250/251-4.
CODE Unit numbers: (a) C19081, C19083, C19109, C19113, C19115,
C19120, C19121, C19122, C19123, C19125, C19126, C19128,
C19129, C19131, C19132, C19135, C19136, C19138, C19139,
C19142, C19143, C19144, C19145, C19149, C19151, C19155,
C19156, C19157, C19159, C19160, C19161, C19162, C19163,
C19165, C19166, C19167, C19169, C19171, C19172, C19173,
C19174, C19175, C19177, C19178, C19179, C19180, C19181,
C19183, C19185, C19187, C19188, C19189, C19190, C19191,
C19192, C19193, C19195, C19196, C19198, C19199, C19200,
C19201, C19203, C19204, C19209, C19210, C19211, C19212,
C19213, C19214, C19216, C19219, C19220, C19221, C19223,
C19224, C19225, C19227, C19228, C19230, C19231, C19232,
C19233, C19234, C19235, C19236, C19237, C19238, C19240,
C19241, C19243, C19244, C19247, C19249, C19252, C19253,
C19254, C19255, C19258, C19260, C19261, C19265, C19267,
C19268, C19272, C19273, C19274, C19275, C19276, C19278,
C19279, C19280, C19283, C19285, C19286, C19287, C19289,
C19290, C19291, C19292, C19293, C19294, C19295, C19297,
C19299, C19300, C19303, C19304, C19305, C19313, C19316,
C19317, C19318, C19319, C19320, C19321, C19322, C19324,
C19325, C19326, C19328, C19329, C19330, C19331, C19333,
C19336, C19342, C19564, C19570, C19573, C19581, C19583,
C19584, C19588, C19589, C19640, C19648, C19650, C19652,
C19658, C19659, C19667, C19670, C19673, C19675, C19741,
C19748, C19756, C19768, C19777, C19778, C19783, C19787,
C19788, C19790, C19800, C19802, C19807, C19809, C19810,
C19811, C19814, C19815, C19816, C19818, C19820, C19821,
C19823, C19824, C19826, C19827, C19829, C19830, C19831,
C19832, C19833, C19835, C19836, C19837, C19838, C19845,
C19871, C19877, C19891, C19896, C19922, C19955, C19963,
C19965, C19970, C19971, C19972, C19973, C19977, C19979,
C19982, C20482, C20484, C20489, C20490, C20496, C20500,
C20510, C20513, C20514, C20518, C20524, C20526, C20528,
C20529, C20531, C20532, C20533, C20534, C20538, C20540,
C20541, C20542, C20545, C20547, C20548, C20550, C20552,
C20554, C20555, C20556, C20557, C20558, C20559, C20560,
C20561, C20564, C20566, C20567, C20571, C20576, C20578,
C20579, C20581, C20587, C20589, C20590, C20591, C20592,
C20593, C20594, C20596, C20597, C20599, C20600, C20601,
C20602, C20604, C20605, C20606, C20607, C20608, C20610,
C20612, C20613, C20615, C20621, C20622, C20623, C20624,
-4- C20625, C20626, C20627, C20628, C20630, C20634, C20637,
C20646, C20652, C20656, C20666, C20668, C20669, C20671,
C20672, C20676, L33339, L33343, L33344, L33348, L33351,
L33355, L33362, L33368, L33374.
(b) C19086, C19112, C19184, C19215, C19217, C19239, C19251,
C19259, C19284, C19288, C19298, C19309, C19310, C19312,
C19643, C19647, C19742, C19743, C19745, C19785, C19803,
C19804, C19805, C19808, C19822, C19825, C19905, C20471,
C20504, C20508, C20546, C20549, C20563, C20582, C20583,
C20584, C20614, C20616, C20618, C20619, C20673.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
RECALLED BY Manufacturer, by letters of August 16, 1993, and September
16, 1993. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY (a) 310 units; (b) 41 units.
REASON Platelets, stored under unacceptable temperatures, were
distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-261-4.
CODE Unit numbers 12K80662, 12Y46475.
MANUFACTURER American Red Cross Blood Services, Charlotte, North
Carolina.
RECALLED BY Manufacturer, by Fax September 27, 1993. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 2 units.
REASON Blood product collected from a donor with a history of
cancer, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-262/264-4.
CODE Unit numbers: 49L59671, 49L59672.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone June 30, 1993, July 8, 1993, and
by letter July 26, 1993, and by Fax July 20, 1993. Firm-
initiated recall complete.
DISTRIBUTION Oklahoma, California.
QUANTITY 2 units of each component.
REASON Blood products manufactured using an unacceptable collection
and processing technique, were distributed.
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells.
Recall #B-265/266-4.
CODE Unit numbers: (a) C26516; (b) C26528, C26547, C26563.
MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford, Illinois.
RECALLED BY Manufacturer, by telephone October 29, 1993, followed by
letter November 23, 1993. Firm-initiated recall complete.
-5- DISTRIBUTION Illinois, Wisconsin.
QUANTITY (a) 1 unit; (b) 3 units.
REASON Blood products, which tested initially reactive for
hepatitis B surface antigen (HBsAg) followed by a single
repeat test, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
UPDATE Recall #Z-299/300-4, which appeared in the May 4, 1994,
Enforcement Report should be corrected as follows:
PRODUCT: Defib-Pads, catalog numbers 2345, 2345N, 2346, and
2346 N.
CODE: Manufacturing dates of JUN.92 through JAN.94 on the
product labels and corresponding "Use By" dates of
JUN.95 through Jan.97.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Evershears Bipolar Coagulating Scissors, Model 3801, used
during laparoscopic surgical procedures for mechanical
cutting and bipolar coagulation using electrosurgical
energy. Recall #Z-676-4.
CODE Lot numbers: XJ934301, AC004326, XJ934601.
MANUFACTURER Everest Medical Corporation, Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone February 28, 1994, and by letter
March 2, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, United Kingdom.
QUANTITY 175 units from lots XJ934301 and AC004326 and 3 units from
lot XJ934601 were distributed.
REASON The ceramic blade of the scissor separates from the metal
support blade during use.
_______________
PRODUCT (a) PCA-10 3 Ring with Rotator 10 cc Disposable Angiography
Control Syringe, sterilized with ethylene oxide gas, non-
pyrogenic, Catalog #C305-0035; (b) Coeur PCA-10 3 Ring with
Rotator 10 cc Disposable Angiograpy Control Syringe, bulk,
non-sterile, Catalog #C305-1035, used for injections into a
patient's vascular system. Recall #Z-703/704-4.
CODE Lot numbers: (a) 50793701, 50893701, 50893702; (b)
50793801, 50893801, 50993801, 51093801, 50593801, 50693801.
MANUFACTURER Coeur Laboratories, Inc., Raleigh, North Carolina.
RECALLED BY Manufacturer, by telephone and letter on December 6, 1993.
Firm-initiated recall complete.
DISTRIBUTION California, New Jersey, Florida, Kentucky, Texas, Virginia,
England, Germany, Australia, Canada.
QUANTITY (a) 1,600 units; (b) 10,900 units were distributed.
-6- REASON Product defect which could allow air bubbles to leak into
the syringe and be injected into the patient.
_______________
PRODUCT TMJ Abrasion Burs for small joint arthroscopy sold under the
Stryker Endoscopy label:
(a) Model 266-641-000, 2 mm; (b) Model 266-647-000, 3 mm.
Recall #Z-709/710-4.
CODE Lot numbers: (a) W0009476-1; (b) W0009477-1.
MANUFACTURER Stryker Puerto Rico, Inc., Arroyo, Puerto Rico.
RECALLED BY Stryker Endoscopy, San Jose, California, by letter March 25,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Hong Kong, West Germany, Mexico.
QUANTITY (a) 54 units; (b) 30 boxes.
REASON The burs did not have suction slots cut into them.
_______________
PRODUCT Medtronic Elite II, Model 7084 Activity Responsive Dual
Chamber Pacemakers. Recall #Z-720-4.
CODE Serial numbers: 3U2000156H-3U2000162H, 3U2000165H-
3U2000168H, 3U2000181H-3U2000184H, 3U2000199H, 3U2000200H,
3U2000202H-3U2000204H, 3U2000279H, 3U2000280H, 3U2000283H -
3U2000286H, 3U2000289H, 3U2000291H-3U2000293H, 3U2000295H -
3U2000299H, 3U2000301H - 3U2000303H, 3U2000305H-3U2000307H,
3U2000311H, 3U2000317H, 3U2000321H, 3U2000323H, 3U2000326H,
3U2000327H, 3U2000331H, 3U2000334H, 3U2000340H, 3U2000341H,
3U2000349H-3U2000367H.
MANUFACTURER Med Rel, Inc., Humacao, Puerto Rico.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by telephone March
10, 1994. Firm-initiated recall complete.
DISTRIBUTION Alaska, California, Colorado, Florida, Georgia, Hawaii,
Iowa, Maryland, Minnesota, New Hampshire, New York, North
Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee,
Texas.
QUANTITY 70 units were distributed; firm estimates none remains on
the market.
REASON The devices were distributed into interstate commerce
without an approved Premarket Approval supplement.
_______________
PRODUCT Pal Pro-Assist Professional Assistance Lift and Full Body
Transfer Lift, motorized patient transport devices:
(a) Model PA100; (b) Model PA200; (c) PA300;
(d) Model PL150; (e) Model PL250. Recall #Z-721/725-4.
CODE All units.
MANUFACTURER Sunrise Machine & Tool, Inc., Detroit Lakes, Minnesota.
RECALLED BY Manufacturer, by letter December 21, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Colorado, Georgia, Iowa, Kentucky, Massachusetts, Michigan,
Minnesota, Montana, North Dakota, South Dakota, Oregon,
Pennsylvania, Tennessee, Texas, Wisconsin.
-7- QUANTITY 124 units.
REASON The legs of the patients lifts could come out of their
channels when used in the narrow position, allowing the main
mast to fall forward, dropping the patient to the floor.
_______________
PRODUCT Night Vision Image Intensifiers, Model T3C-2, used for
viewing objects and persons in subdued lighting.
Recall #Z-748-4.
CODE Model T3C-2.
MANUFACTURER Novosibirsk Instrument Making Plant, in Novosibirsk Russian
Federation.
RECALLED BY Sentinel Electronics, Bristol, Pennsylvania (importer). FDA
approved the firm's corrective action plan April 18, 1994.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 16 units.
REASON Product contains a radiation defect, in that the products
emit x-radiation that is unnecessary to the accomplishment
of the purpose of the product, and create a risk of injury
to users.
_______________
PRODUCT Arrow Two-Lumen Central Venous Catherization Kit containing
the spring wire guide, which was the subject of the
packaging error. The spring wire guide is used to guide the
catheter into the correct position. Recall #Z-753-4.
CODE Lot #AK-2-260-3.
MANUFACTURER Arrow International, Inc., Randleman, North Carolina.
RECALLED BY Arrow International, Inc., Reading, Pennsylvania, by visit
starting October 11, 1993. Firm-initiated recall complete.
DISTRIBUTION Georgia, New Jersey, California, New York.
QUANTITY 30 cases (5 kits per case) were distributed; firm estimates
none remains on the market.
REASON The catheter is not usable with a 0.035" diameter spring
wire guide (which was incorrectly packaged into the recalled
catheter kit).
_______________
PRODUCT HAID Universal Bone Plate (UBP) System, used for a variety
of operative procedures:
(a) Part #650005-002, Catalog No. S/L 50-4551 (Small Set);
(b) Part #650005-003, Catalog No. S/L 50-4552 (Standard
Set);
(c) Part #650005-004, Catalog No. S/L 50-4553 (Large Set);
(d) Part #650005-005, Catalog No. S/L 50-4554
(Evaluation Set). Recall #Z-755/758-4.
CODE All units manufactured and distributed between July 16, 1991
and February 9, 1993.
MANUFACTURER American Medical Electronics, Inc. (AME), Richardson, Texas.
-8- RECALLED BY Manufacturer, by letter February 9, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 548 UBP systems and an undetermined quantity of bone plates
and screws ordered as refills.
REASON The new intended use for the devices in the cervical spine
(fixation/stabilization) does not have a required premarket
approval.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Sterile Gelfilm absorbable gelatin film, USP and Sterile
Ophthalmic Gelfilm, USP, for use in neurosurgery and
thoracic and ocular surgery. Recall #Z-632-4.
CODE Lot numbers: 407FR, 438FS, 414FR, 442FS.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter April 15, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 891 units were distributed.
REASON Products failed to meet the USP digestibility specification
within the labeled expiration period.
_______________
PRODUCT Sterile 7 x 30 mm Cannu-Flex Silk Interference Screw,
Catalog #014202, in double tyvek blister package.
Recall #Z-685-4.
CODE Lot #001097.
MANUFACTURER Acufex Microsurgical, Inc., Mansfield, Massachusetts.
RECALLED BY Manufacturer, by voice mail January 5, 1994, and by letter.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 106 units were distributed.
REASON Product was labeled 7 x 30 mm CannuFlex SilkSrew, but
actually contained non-cannulated 7 x 30 mm Interference
Screw.
_______________
PRODUCT Abbott IMx CK-MB Controls, for verification of the
calibration of the IMx Analyzer used for the determination
of human CK-MB, in 3 - 8 ml bottles; (b) Abbott IMx CK-MB
Mode 1 Calibrator, for in-vitro diagnostic use with IMx CK-
MB, in 3 - 4 ml bottles with (human) heart CK-MB in human
serum with protein stabilizers, 30 mg/ml.
Recall #Z-730/731-4.
CODE Lot numbers: (a) 78833Q100 EXP 3/18/94, 80198M200 EXP
5/9/94; (b) 80627M200 EXP 5/9/94.
MANUFACTURER Abbott Laboratories, Diagnostics Division Abbott Park,
Illinois.
-9- RECALLED BY Manufacturer, by telephone beginning August 31, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Canada, France, Japan, Korea, Singapore.
QUANTITY 774 control packs and 604 Mode 1 calibrators were
distributed.
REASON Devices were found to have loss potency due to thermal
stress causing chemical degradation, which may result in
controls reading outside of specifications causing invalid
assay results.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
==========
_______________
PRODUCT Urea bolus, 13.4 grams/bolus, packaged in 50 and 25 pound
bottles, an OTC intrauterine antiseptic distributed under
the following labels:
(a) Antisepsis Bolus, manufactured by Sparhawk Laboratories,
Inc., Kansas City, KS;
(b RXV Products, After-Birth, manufactured for RX Veterinary
Products, Porterville, CA
(c) Uterine Bolus, manufactured for Animal Health Associates
Kansas City, MO
(d) AGRIpharm After-Birth, manufactured for Dealer
Distribution of America, Kansas City, MO
(e) Butler Uterine Bolus, manufactured for The Butler
Company, Columbus, OH
(f) AgriLabs Intrauterine Bolus, manufactured for Agri
Laboratories, Ltd., St. Joseph, MO
(g) Uterine Bolus, manufactured for Phoenix Pharmaceutical
Inc., St. Joseph, MO
(h) Animal Medic Uterine Medic Bolus, manufactured for
Animal Medic Inc., Manchester, PA
(i) L and M Pharmaceuticals Intrauterine Bolus, manufactured
for L and M Pharmaceuticals, Dallas, Tx. Recall #V-042-4.
CODES (a) 930307 through 930310; (b) 930312; (c) 930321;
(d) 930323; (e) 930406 through 930411; (f) 930455, 930456
(g) 930463 through 930465; (h) 930512 through 930515;
(i) 930536 through 930539.
MANUFACTURER Veterinary Laboratories, Inc., Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on or about June 15, 1993, and by
letter March 18, 1994. Firm-initiated recall complete.
DISTRIBUTION Missouri, Alabama, Colorado, Nebraska, California, New York,
Iowa, Maine, Pennsylvania, Ohio, Texas, Massachusetts
and Puerto Rico.
QUANTITY 3,803 50-bolus bottles and 300 25-bolus bottles of lots
930307 through 930323 were distributed.
13,117 50-bolus bottles and 300 25-bolus bottles of lots
930406 through 930539 were distributed.
-10- REASON Lots 930307 through 930323 recalled due to stability samples
swelling and becoming soft. Lots 930406 through 930539 were
subpotent.
SEIZURES:
=================================================================
_______________
PRODUCT Picked Crab Meat, Cooked Whole Crabs, and Crab Shells
(intended for use as serving dishes)(94-682-795/809).
CHARGE Adulteration - One of the articles bears or contains a
poisonous and deleterious substance, the microorganism
Listeria monocytogenes, which may render it injurious to
health; some of the articles consist in part of a filthy
substance by reason of the presence therein of animal hair;
some of the articles consist in part of a filthy substance
by reason of the presence therein of the bacteria
Escherichia coli; some of the articles consist in part of a
decomposed substance by reason of the presence therein of
decomposed crab meat; and all of the articles have been
prepared, packed, and held under insanitary conditions
whereby they may have become contaminated with filth.
LOCATION Barwick Crab Company, Crawfordville, Florida.
FILED March 29, 1994; U.S. District Court for the Northern
District of Florida, Tallahassee Division; Civil #CIV-94-
40130; FDC #66931.
SEIZED April 19, 1994 - goods valued at approximately $15,000.
_______________
PRODUCT Frozen Yellow Fin Tuna Loins (94-447-479).
CHARGE Adulterated - The article consists in part of decomposed
fish.
LOCATION Alterman Cold Storage Company, Pensacola, Florida.
FILED March 16, 1994; U.S. District Court for the Northern
District of Florida, Pensacola Division; Civil
#CIV-94-30091; FDC #66942.
SEIZED March 21, 1994 - goods valued at approximately $12,000.
_______________
PRODUCT Frozen Yellow Fin Tuna Steaks (94-629-602).
CHARGE Adulterated - The article consists in part of decomposed
fish.
LOCATION Cityice Cold Storage Company, LaConner, Washington.
FILED March 22, 1994; U.S. District Court for the Western
District of Washington; Civil #C94-0415Z; FDC #66947.
SEIZED March 31, 1994 - goods valued at approximately $35,000.
_______________
PRODUCT Sodium Citrate (94-688-047).
CHARGE Adulterated - The article is unfit for food because of the
presence of foreign material including plant matter and a
rubber-like material visible to the naked eye.
-11- LOCATION G.S. Robins and Company, Springfield, Missouri.
FILED April 12, 1994; U.S. District Court for the Western
District of Missouri, Southern Division; Civil #94-3152-CV-
S-4; FDC #66954.
SEIZED April 29, 1994 - goods valued at approximately $19,127.
-12-
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END OF ENFORCEMENT REPORT FOR MAY 11, 1994. BLANK PAGES MAY FOLLOW.