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
01/03/1996
ENFORCEMENT REPORT FOR 01/03/96
January 3, 1996 96-01
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Kellogg's Low Fat Pop-Tarts with Smucker's Real Fruit
Frosted Strawberry with Natural and Artificial Flavors.
Recall #F-138-6.
CODE Retail cartons are imprinted 06055GA1.
MANUFACTURER Keebler Company, Grand Rapids, Michigan.
RECALLED BY Kellogg Company, Battle Creek, Michigan, by press release on
August 4, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,875 cases of 12 cartons each were distributed.
REASON The strawberry Pop-Tarts cartons actually contain chocolate
fudge pop-tarts.
_______________
PRODUCT Frozen Yellow Fin Tuna: (a) IQF Tuna Pieces;
(b) 4 ounce Tuna Steaks; (c) 6 ounce Tuna Steaks;
(d) 8 ounce Tuna Steaks; (e) 4 ounce Tuna Sandwich Cuts.
Recall #F-139/143-6.
CODE First four digits involved are: 2615, 2265, 2275, and 2285.
Last four digits involved are: 7734 and 7658.
MANUFACTURER Tyson Seafood Group, Seattle, Washington.
RECALLED BY Tyson Foods, Inc., Springdale, Arkansas, by letter faxed on
November 30, 1995. FDA-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Two raw material lots were commingled to manufacture the
below listed lot totaling 14,640 lbs.
Lot 2615SEA03__-7734
Product Code Description Cs made Cs dist
98575-895 Sysco 8 oz. stks 1/10# 358 358
98574-895 Sysco 6 oz. stks 1/10# 492 384
98575-036 8 oz. steaks 1/10# 73 0
98573-895 Sysco 4 oz. stks 1/10# 150 149
98574-036 6 oz. steaks 1/10# 76 76
98573-036 4 oz. steaks 1/10# 83 0
98572-538 IQF tuna pieces 1/40# 58 58
Two raw material lots were commingled to manufacture the
below listed lots totaling 33,730 lbs.
Lots 2265EA03__7658, 2275SEA03__7658, and 2285SEA03__7658
Product Code Description Cs made Cs dist
98577-036 4 oz. sand. cuts 1/10# 164 149
98574-895 Sysco 6 oz. stks 1/10# 800 800
98575-895 Sysco 8 oz. stks 1/10# 905 905
98575-036 8 oz. steaks 1/10# 170 55
98574-036 6 oz. steaks 1/10# 241 241
98572-538 IQF tuna pieces 1/40# 144 144
98573-895 Sysco 4 oz. stks 1/10# 150 150
98573-036 4 oz. stks 1/10# 367 367
REASON Product is decomposed and contains hazardous levels of
histamines.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Pope brand Imported Tomato Paste in 6 ounce cans.
Recall #F-137-6.
CODE Can Code: APE 4 R 048.
MANUFACTURER T.E.C., Pompeii, Italy.
RECALLED BY Pope Foods, Inc., Oradell, New Jersey, by telephone followed
by fax on June 30, 1995, . Firm-initiated recall complete.
DISTRIBUTION New York, New Jersey, Connecticut.
QUANTITY 10,565 cases (48 cans per carton) were distributed.
REASON The label of the product showed "Product of Italy" on the
bottom label and "Product of Hungary" on the top label. The
label also had different brand names.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Levothyroxine Sodium Tablets, USP, 0.1 mg, 0.125 mg, 0.15
mg, 0.2 mg, and 0.3 mg, Rx oral synthetic thyroid hormone
used as replacement or supplemental therapy in patients with
hypothyroidism; Packaged by Allscrips Pharmaceuticals Labs.,
Inc.:
(a) 0.1 mg tablets, in 30 and 100 tablet bottles
(b) 0.125 mg tablets, in 30 tablet bottles
(c) 0.15 mg tablets, in 30 and 100 tablet bottles
-2- (d) 0.2 mg tablets, in 30, 100 and 1000 tablet bottles
(e) 0.3 mg tablets, 100 tablet bottles.
Recall #D-050/054-6.
CODE All lots with expiration dates between and including 3/31/95
and 3/31/96.
MANUFACTURER Chelsea Laboratories Caribe, Inc., Bayamon, Puerto Rico.
RECALLED BY Allscrips Pharmaceuticals Inc., Vernon Hills, Illinois
(repacker), by letters dated April 10, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 4,429 bottles of 100 and 1857 bottles of 30; (b) 69
bottles of 30; (c) 305 bottles of 100 and 352 bottles of 30;
(d) 1 bottle of 1000, 165 bottles of 100 and 154 bottles of
30; (e) 65 bottles of 100 were distributed, with the firm
estimating that 15% of the product remained on the market at
time of recall initiation.
REASON Potency not assured through expiration date.
_______________
PRODUCT Arthritis Pain Reliever, repacked from bulk into 100 tablet
bottles, OTC product intended for relief of pain associated
with arthritis. Recall #D-055-6.
CODE Lot numbers: 029545 and 059527.
MANUFACTURER Wildflower Pharmacal Corporation, Mineola, New York (bulk).
RECALLED BY Professional Formulations, Inc., (PFI), Ronkonkoma, New York
(repacker), on or about June 1995. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 4,800 bottles of each lot were distributed; firm estimates
none remains on the market.
REASON Analysis disclosed values of 0% and 62% active ingredient
respectively for the two referenced lots.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-169-6.
CODE Unit numbers: 04T05045, 04T03641, 04LQ08017.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone on November 17, 1994, followed by
letter November 25, 1994. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 3 units.
REASON Blood products, collected from a donor with a history of
cancer, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-153/156-6.
CODE Unit numbers: (a) 8063344, 8211879, 8383561; (b) 8383561;
(c) 8063344; (d) 8383561.
-3- MANUFACTURER The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
RECALLED BY Manufacturer, by letter dated April 24-29, 1993. Firm-
initiated recall complete.
DISTRIBUTION California, Florida.
QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit; (d) 1 unit.
REASON Blood products, which were collected from a donor whose
spouse has a history of IV drug use, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-173/175-6.
CODE Unit numbers: (a) 04FK92667, 04FK02125; (b) 04L00363; (c)
04L00363, 04FK02125, 04FK92667.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letters dated October 27, 1994, December
22, 1994, and November 3, 1994. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts, Maine, California.
QUANTITY (a) 2 units; (b) 1 units; (c) 3 units.
REASON Blood products, which were incorrectly tested for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV), or were collected from a donor who was previously
tested incorrectly for anti-HCV, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma; (c) Red Blood
Cells, expired, for further manufacture.
Recall #B-176/178-6.
CODE Unit numbers: 04W73098, 04W74248, 04W75003, 04W75963,
04GR06518, 04LQ08239, 04C48326.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letters dated July 25, 1994, July 19, 1994.
Firm-initiated recall complete.
DISTRIBUTION Minnesota, Massachusetts, Maine, California.
QUANTITY 7 units of each component.
REASON Blood products, which were incorrectly tested for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV), or were collected from a donor who was previously
tested incorrectly for anti-HCV, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-179/180-6.
CODE 04FK36333, 04KF32412, 04FW01644, 04FN07523, 04FS40177,
04FK21580, 04FR57635, 04FK17740, 04FS27264, 04FS24089,
04FR45925.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letters dated December 9, 1994 and November
28, 1994. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maine, California, Switzerland.
QUANTITY 11 units of each component.
-4- REASON Blood products, which tested negative for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot indeterminate, were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-160-6.
CODE Unit #8542671.
MANUFACTURER The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
RECALLED BY Manufacturer, by letter dated March 28, 1995. Firm-
initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY 1 unit.
REASON Blood product, which was exposed to improper storage and
unacceptable temperatures, was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-170-6.
CODE Unit numbers: 04T05045, 04T03641, 04LQ08017.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone November 17, 1994, followed by
letter dated November 25, 1994. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts.
QUANTITY 3 units.
REASON Blood products, collected from a donor with a history of
cancer were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT Hewlett Packard M0125B Anesthetic Gas Analyzer,
simultaneously monitors the inspired and expired
concentrations of 02, CO2, NO2, and anesthetic agent
(isofuirane, enflurane, halothane, sevoflurane
ordesflurane). At the same time, it also monitors the
patients respiration peripheral oxygen saturation and pulse.
Recall # Z-243-6.
CODE Model M1025B with serial numbers
2938D00060 3244D00738 3244D00995 3244D01094
3016D00120 3244D00745 3244D00997 3244D01109
2016D00199 3244D00777 3244D00998 3244D01141
3045D00255 3244D00787 3244D00999 3244D01160
3209D00510 3244D00867 3244D01000 3244D01162
3209D00578 3244D00877 3244D01011 3244D00171
3209D00613 3244D00878 3244D01013
and serial numbers 3244D01221 to 3244D01390 (inclusive).
MANUFACTURER Bruel & Kjaer, Denmark for Hewlett Packard GmbH, Medical
Products Group, Schickardstr, Germany.
-5- RECALLED BY Hewlett Packard Company, Andover, Massachusetts, by letter
in October 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Latin America.
QUANTITY 81 units.
REASON Failure of a component in the analyzer can cause the
measured partial pressures of respired gases (CO2, N20, and
anesthetic agent) to drift up to 60% from the true value.
_______________
PRODUCT (a) Cobe Precision Blood Pump; (b) Cobe Spare Part - Remote
Potentiometer. Recall #Z-257/258-6.
CODE (a) Catalog Nos. 043600000, 043600002, 043600004, 04300005,
043600006, 043600007, 043600009, 043600090, 043600700,
043601-001, 043601-002, 600600-600;
Serial Numbers: 1723AB, 2123AH, 2152AH, 2155AH, 2264AH,
2265AH, 3010AP, 4524, 4744, 4745, 4749, 4750, 4828, 4830,
4865, 4879, 4914, 4918, 4920, 4922, 4939, 5057, 5162, 5168,
5170, 5172, 5176, 4180, 5181, 5183, 5188, and 5214 through
6330.
(b) Catalog Number 600052-001
Lot Numbers: 12Y13607, 01Z13640, 02Z13631, 04Z13684,
05Z13615, 06Z13643, 10Z13714, 11Z13610, 12Z13640, 01A13645,
01A13687, 03A13602, 04A13645, 04A13679, 06A13642, 07A13622,
07A13736, 08A13705.
MANUFACTURER Cobe Cardiovascular, Inc., Arvada, Colorado.
RECALLED BY Manufacturer, by telephone between October 12, 1995 and
November 8, 1995, followed by letter on October 12, 1995.
Firm-initiated field correction ongoing.
DISTRIBUTION (a) Nationwide and international; (b) California, Florida,
Georgia, Illinois, Kansas, Louisiana, Michigan, Missouri,
New Jersey, New Mexico, North Carolina, Tennessee, and
international.
QUANTITY (a) 1,147 pumps; (b) 112 spare parts remote potentiometers
were distributed.
REASON The pumps may spontaneously increase in speed and/or may
prevent the operator from stopping the rotation of the pump
head via the Speed Control knob on the pump's front panel.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Propaq Encore Portable Patient Vital Signs Monitor with
Software Version 1.10.00. Recall #Z-254-6.
CODE Code nos. involved; DA000716, DA000719, DA000744, DA000977,
DA000227, DA000340, DA000371, DA000629, DA000710, DA000804,
DA000810, DA000842, DA000948, DA000965, DA000966, DA000462,
DA000448, DA000648, DA000460.
MANUFACTURER Protocol Systems, Inc., Beaverton, Oregon.
RECALLED BY Manufacturer. As of 11/2/95, the firm had installed the
upgraded software on 18 of the 19 affected devices.
DISTRIBUTION Oklahoma, Colorado, Texas, Switzerland, Denmark, England.
QUANTITY 19 units.
-6- REASON It was determined that if the device is used with old or
expired electrodes, one of two things may happen: 1) an
error message will be displayed in lieu of an equipment
alert message in the 5 lead mode or, 2) no alert message
will be displayed in the 5 lead mode when only 3 leads of a
5 lead cable are connected to the patient. The equipment
alert message that should occur when old or expired
electrodes are used with the device is one that indicates
that the leads have failed and that the electrodes should be
replaced.
_______________
PRODUCT (a) Q-710 Stress Electrocardiograph; (b) Q-4500 Stress Test
System. The Q-4500 and Q-710 are model numbers for the
monitoring device interfacing with the treadmills for the
purpose of conducting stress tests. Recall #Z-255/256-6.
CODE Serial numbers: (a) 101 through 181; (b) 2171 through 2284.
MANUFACTURER Quinton Instrument Company, Bothell, Washington.
RECALLED BY Manufacturer, by telephone between October 11 and 16, 1995.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 192 units.
REASON The treadmill may increase in speed when the "Stop Exercise"
control button is depressed.
_______________
PRODUCT DLP brand 32 FR Size Single Stage Venous cannulae, Product
#66132. Recall #Z-259-6.
CODE Lot #6950-9007.
MANUFACTURER Medtronic, Inc., Grand Rapids, Michigan.
RECALLED BY Manufacturer, by telephone on October 12, 1995. Firm-
initiated recall complete.
DISTRIBUTION North Carolina, Ohio, Pennsylvania, Florida.
QUANTITY 61 units were distributed; firm estimates none remains on
market.
REASON A 28 FR cannula body was used in assembly instead of a 32 FR
cannula body.
_______________
PRODUCT Growth-Chek Microbial Suspensions, containing Candida
albicans derived from ATCC Culture #10231 in plastic screw
cap vials. Recall #Z-266-6.
CODE Lot numbers: 100695 EXP 1/6/96, 101395 EXP 1/13/96.
MANUFACTURER B.E.C. Laboratories, Inc., Toledo, Ohio.
RECALLED BY Manufacturer, by telephone on November 2, 1995, followed by
letter dated November 9, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Singapore.
QUANTITY Firm estimated that 19 vials of lot 100695 and 9 vials of
lot 101395 remained on the market at time of recall
initiation.
-7- REASON The population of Candida albicans in these lots exceeds the
certified population for usage.
-8-
END OF ENFORCEMENT REPORT FOR JANUARY 3, 1996. BLANK PAGES MAY
FOLLOW.
####