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
10/26/1994
Recalls and Field Corrections: Foods -- Class I -- 10/26/1994
October 26, 1994 94-43
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Libby's brand Crispy Sauerkraut, in 32 ounce glass jars.
Recall #F-011-5.
CODE Lot numbers: BMEH1, BMEH2, BMEH3 (packed on 2/11/94); BPEH1,
BPEH2 (packed on 2/14/94); CPEH1, CPEH2, CPEH3 (packed on
3/14/94); CREH1, CREH3 (packed on 3/15/94); H2EH3, H2EH4,
H2EH5, H2EH6 (packed on 8/24/94).
MANUFACTURER Seneca Foods Corporation, Jackson, Wisconsin.
RECALLED BY Seneca Foods Corporation, Marion, New York, by fax September
19, 1994, followed by letter September 20, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13,613 cases (12 jars per case) were distributed; firm
estimated that 3,000-4,000 jars remained on market at time of
recall.
REASON Product label does not declare the presence of sulfites.
_______________
PRODUCT Food Club and Big Y brands Florentine Style Vegetables in 16
ounce packages, a mixture of frozen broccoli, carrots and
cauliflower. Recall #F-012-5.
CODE Two line code H94LK5/D411502.
MANUFACTURER Lakeside Foods, Inc., Manitowoc, Wisconsin.
RECALLED BY Manufacturer, by letter and by press release September 23,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Wisconsin, Illinois, Pennsylvania, West Virginia,
Massachusetts, Vermont.
QUANTITY 437 cases (12 bags per case) were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Carnation Good Start Infant Formula Concentrated Liquid in 13
fluid ounce cans. Recall #F-013-5.
CODE Lot numbers: 4067EWGC447 (U.S.); 4062EWGC443 and 4067EWGC446
(Canada).
MANUFACTURER Nestle Food Company, Eau Claire, Wisconsin.
RECALLED BY Nestle USA, Inc., Glendale, California, by issuing a sales
department bulletin on July 13, 1994. Firm-initiated recall
complete.
DISTRIBUTION Arizona, California, Colorado, Idaho, Nevada, Oregon, Utah
Washington state, Wisconsin, Canada.
QUANTITY 16,878 cases were distributed; firm estimates none remains on
the market.
REASON A small number of cans were found to contain non-pathogenic
spoilage organisms indicating the product has the remote
possibility of being contaminated with other microorganisms.
_______________
PRODUCT (a) Caramel and (b) Lemon-Yellow Sweet Frosted Popcorn, in 4
ounce bags. Recall #F-015/016-5.
CODE Product is identified by the last 5 numbers of the UPC code:
00840 (Caramel Sweet Frosted Popcorn); 00870 (Lemon-Yellow
Popcorn).
MANUFACTURER Judy's Gourmet Popcorn, Inc., Jackson, Michigan.
RECALLED BY Manufacturer, by telephone on or about October 14, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Michigan, Ohio, Illinois, Indiana.
QUANTITY (a) 264 cases (12 bags per case); (b) 324 cases (12 bags per
case) were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Balsamic Vinegar in 8.8 ounce bottles. Recall #F-014-5.
CODE Lot #L3033.
MANUFACTURER Cesare Fiorucci S.p.A., Rome, Italy.
RECALLED BY Fiorucci Foods, Colonial Heights, Virginia, by letter on or
about June 10, 1994. Firm-initiated field correction
(relabeling) complete.
DISTRIBUTION New Jersey, New York, Pennsylvania, Florida, Wisconsin, Rhode
Island, Connecticut, Massachusetts, Virginia, California.
QUANTITY 50 cases (6 bottles per case) were distributed.
REASON Product contains undeclared sulfites.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Prednisone Tablets USP (a) 5 mg; (b) 10 mg, Rx adrenocortical
steroids in bottles of 1000, 500 and 100 tablets.
Recall #D-014/015-5.
CODE Lot numbers and EXP dates:
(a) 097L2 11/94, 098L2 11/94, 050C3 3/95, 051C3 4/93,
065F3 7/95, 066F3 6/95, 066J3 10/95, 067J3 10/95, 022A4 2/96,
002B4 2/96 (1000's);
(b) 060H2 10/94, 011B3 2/95, 071E3 5/95, 067G3 8/95,
085K3 10/95, 003B4 2/96 (100's); 012B3 2/95, 066G3 8/95,
084K3 10/95, 061H2 10/94, 059L2 11/94, 060L2 11/94,
072E3 5/95 (500's).
MANUFACTURER Purepac Pharmaceutical Company, Elizabeth, New Jersey.
RECALLED BY Manufacturer, by letter August 9, 1994. Firm-initiated recall
complete.
DISTRIBUTION Undetermined.
QUANTITY (a) 77,476 bottles of 1000; (b) 305,522 bottles of 100 and
38,646 bottles of 500 were distributed.
REASON Products may not meet dissolution/stability specifications
through expiration date.
_______________
PRODUCT Bacitracin Ointment, USP, in 1/2 ounce tubes, applied
topically to help prevent infection in minor cuts, scrapes and
burns. Recall #D-016-5.
CODE Lot #3J657 EXP 10/95.
MANUFACTURER NMC Laboratories, Inc., Glendale, New York.
RECALLED BY Manufacturer, by letter September 30, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 21,690 tubes were distributed; firm estimated that 2,000 units
remained on the market at time of recall.
REASON A unit carton of Bacitracin Ointment contained a tube of
Nystatin-Triamcinolone Cream.
_______________
PRODUCT Oral-B Laboratories Anti-Plaque Alcohol Free Mouth Rinse, in
2 ounce bottles. Recall #D-017-5.
CODE Lot #4P16064 EXP 2/96.
MANUFACTURER CCL Industries, Toronto, Ontario, Canada.
RECALLED BY Oral-B Laboratories, Redwood City, California, by undated
letters sent during the week of October 10, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, New Zealand.
QUANTITY 84,720 units were distributed.
REASON Some bottles were found to contain Pseudomonas cepacia.
-3- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Methadone Hydrochloride, oral solution, USP 5 mg per ml, in
500 ml bottles, used for treatment of narcotic addiction.
Recall #D-012-5.
CODE Lot #941390 EXP 9/1/98.
MANUFACTURER Roxane Laboratories, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter October 5, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,192 bottles were distributed.
REASON Some bottles were found to have Metoclopramide Solution
outserts.
_______________
PRODUCT Tegretol 200 mg Tablets (Carbamazepine USP) 100 tablets, in
unit dose package, an anticonvulsant and specific analgesic
for trigeminal neuralgia. Recall #D-013-5.
CODE Lot #1T157629 EXP 7/98.
MANUFACTURER Ciba Pharmaceuticals Division, Suffern, New York.
RECALLED BY Manufacturer, by Ciba-Geigy Corporation, Summit, New Jersey,
by letter September 6, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 32,517 boxes (100 tablets each) were distributed.
REASON Delamination of blister packaging.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Platelets. Recall #B-003-5.
CODE Unit numbers: 1B2665, 1B2668, 1B2698, 1B2699, 5E9485, 4F7314,
4F7317, 9T6258, 9T6299.
MANUFACTURER Puget Sound Blood Center (PSBC), Seattle, Washington.
RECALLED BY Manufacturer, by telephone June 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Washington State.
QUANTITY 9 units.
REASON Blood products, which were labeled with an incorrect
expiration date, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-004-5.
CODE Unit #15KG20320.
MANUFACTURER The American National Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by letter February 11, 1994. Firm-initiated
recall complete.
DISTRIBUTION Montana.
QUANTITY 1 unit now out of distribution.
REASON Blood product, collected from an ineligible donor due to
travel in an area endemic for malaria, was distributed.
-4- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Forma Scientific Freezers, Ultra Low Temperature (ULT)
Freezers, used in the freezing and storage of blood components
and laboratory supplies, as well as other laboratory
applications. Recall #B-005-5.
CODE Model numbers: 816, 817, 823, 825, 826, 838, 839, 0858, 859,
8416, 8417, 8423, 8425, 8426, 8436, 8438, 8439, 8440, 8442,
8445, 8452, 8458, 8460.
MANUFACTURER Bristol Compressors, Bristol, Virginia (supplier of
compressor).
RECALLED BY Forma Scientific, Inc., Marietta, Ohio, by letter dated
October 12, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 415 freezers.
REASON Ultra Low Temperature freezers with faulty compressors were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-006/007-5.
CODE Unit #3M8179.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone in September 1993. Firm-initiated
recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had
received the Mumps, Measles, and Rubella (MMR) vaccine one
week prior to donation, were distributed.
_______________
PRODUCT Platelets. Recall #B-013-5.
CODE Unit numbers: 42FJ17572, 42FJ17584, 42FJ17590, 42FJ17596.
MANUFACTURER American National Red Cross (The), Columbus, Ohio.
RECALLED BY Manufacturer, by letter July 20, 1993. Firm-initiated recall
complete.
DISTRIBUTION Ohio.
QUANTITY 4 units.
REASON Blood products, which were exposed to unacceptable shipping
temperatures, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-014-5.
CODE Unit #NA26013.
MANUFACTURER East Texas Blood Center, Nacogdoches, Texas.
RECALLED BY Manufacturer, by telephone May 16, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect expiration
date, was distributed.
-5- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Optum Peritoneal Exchange Device, used to aseptically exchange
used bags of dialysate solution with new bags. Machine
automatically unspikes the old bag and spikes the new bag.
(Note: Device may bear the old Abbott Labs name or the new
Fresenius name). Recall #Z-009-5.
CODE All units. Serial numbers 10001 through 13748.
MANUFACTURER Random Corporation, Cincinnati, Ohio (contract manufacturer).
RECALLED BY Fresenius USA, Inc., Walnut Creek, California, by telephone
during the week of September 12, 1994, followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 975 were distributed.
REASON The device fails to spike or adequately spike new dialysate
bags.
_______________
PRODUCT Coated VICRYL (Polyglactin 910) Absorbable, Sterile Sutures:
(a) Precision Point--Reverse Cutting;
(b) Precision Point--Conventional Cutting;
(c) Precision Cosmetic--Conventional Cutting;
(d) Reverse Cutting;
(e) Taper Point;
(f) Tapercut;
(g) Sabreloc--Spatula;
(h) Straight Cutting;
(i) E-Pack Procedure Kits (containing any of the affected
sutures. Recall #Z-013/021-5.
CODE Product Codes - Lot Numbers
(a) J426H GC9678, GD9575;
J427H GD9037, GD9548;
J464G GD9057;
J490G GC9956, GD9056, GD9422;
J493G GD9088, GD9106, GD9110;
J493H GC9363, GD9425, GD9570;
J494G GC9740, GC9741, GC9850, GD9140, GD9501,
GD9502, GD9476;
J494H GC9360, GC9982, GD9087, GD9522;
J495G GD9114;
J495H GD9104, GC9692;
J496G GD9689;
J496H GC2365, GC2449, GC2544, GD9014, GD9015,
GD9145, GD9173, GD9503;
J497G GC2335, GD9113, GD9835;
J497H GC9834, GC9967, GD9032, GD9690, GD9452;
J500G GC2331, GD9035, GD9573;
J500H GC9676;
J502H GD9483;
J506G GC9983;
J511G GD9694;
J513G GD9528;
-6- J593G GD9019;
J594G GC2546;
J596H GD9174;
J610H GD9176;
J682G GC2446, GD9101;
J682H GD9699;
J683G GD9572;
J683H GC9919, GD9036, GD9596;
J935H GC9951, GD9083, GD9500, GD9529;
J936H GC2329, GC9980, GD9012.
(b) J598G GC9918.
(c) J813G GC9998;
J814G GD9109;
J822G GC9916, GD9527;
J823G GC2363;
J823H GD9830;
J824G GD9591;
J834G GD9524;
J835G GC2548, GD9733;
J844G GC2328;
J845G GC2547, GD9020.
(d) J196H GC9838, GD9038;
J266H GD9039, GD9040, GD9884;
J267H GD9532, GD9533;
J268H GD9041, GD9093, GD9704, GD9713;
J386H GD9310;
J391H GC9679, GC9836, GD9111;
J392H GD9102, GD9594;
J393H GD9574;
J396H GD9171;
J397H GD9142, GD9531;
J398H GD9506;
J421H GC2447, GD9426, GD9525, GC9799;
J422H GB2362, GC2392, GC9810, GC9831, GD9085,
GD9428, GD9450;
J423H GD9013, GD9505, GD9595;
J441H GC9976, GD9016, GD9691;
J442H GC9835, GD9430, GD9482;
J443H GC2554;
J451H GD9031;
J453H GC9811, GD9005, GD9006, GD9461, GD9462,
GD9119;
J455H GD9166;
J458H GD9092, GD9545;
J459H GC9977, GD9423;
J460H GD9117;
J461H GC9954;
J466H GD9074, GD9121;
J467H GD9546, GD9547;
J468H GD9075, GD9094, GD9703;
J472H GD9577, GD9921;
J479H GC2374, GC9940;
-7- J480H GC9837, GD9129;
J484H GC9941;
J533H GC2379, GD9682;
J534H GC9845, GC9785, GD9078, GD9079, GD9767;
J535H GC2381, GD9756;
J586H GC9955, GD9908;
J588H GC9770, GD9115, GD9576;
J589H GC2394;
J695H GC9943;
J698H GD9459;
J869H GC9936;
J870H GC9935, GD9753;
J871H GC2515, GD9487.
(e) J213H GC2372, GC9594, GD9138;
J214H GC2373, GC2551, GD9445, GD9749;
J215H GC2333, GD9478, GD9832;
J218H GC9501, GD9017;
J219H GC9581;
J232H GD9097, GD9725;
J258H GD9060, GD9061, GD9062, GD9301, GD9848;
J259H GC9690, GD9024, GD9025, GD9027;
J260H GD9000, GD9001, GD9466;
J261H GC9973, GD9002;
J269H GD9178, GD9886;
J270H GC2349, GD9043;
J274H GC9923, GD9712;
J280H GD9045, GD9514;
J281H GC9925;
J303H GD9732;
J306H GD9739;
J314H GC9828;
J315H GC9944, GD9004, GD9046, GD9432;
J316H GC2527, GC9841, GC9842, GC9946, GC9961,
GD9534, GD9584;
J317H GC2435, GD9686, GD9701, GD9866;
J318H GD9187;
J323H GD9758;
J324H GC2459, GD9536;
J329H GC2552;
J332H GD9705, GD9729, GD9154, GD9181, GD9680;
J333H GD9096, GD9122, GD9453, GD9512, GD9513,
GD9491, GD9707, GD9708, GD9766;
J334H GC9926, GD9125, GD9126, GD9147, GD9148,
GD9490, GD9510, GD9511, GD9762;
J335H GD9507, GD9508, GD9509;
J338H GC9993, GD9550;
J339H GC2455, GD9470, GD9471, GD9472, GD9473,
GD9474, GD9516, GD9517, GD9518, GD9788;
J340H GC9985, GD9986, GC9987, GC9988, GC9989,
GC9990, GD9065, GD9464, GD9465, GD9558,
GD9559, GD9560, GD9561, GD9563, GD9564,
GD9792, GD9794;
-8- J341H GD9028;
J343H GC9927;
J344H GD9197, GD9198;
J345H GC2337, GC2338, GD9151, GD9436, GD9458,
GD9488;
J346H GD9137, GD9199, GD9521, GD9553, GD9554;
J351H GC2351, GD9011, GD9538, GD9723;
J352H GD9443, GD9444, GD9599, GD9785;
J353H GC9929, GD9515;
J357H GC2484, GD9685;
J358H GC2340, GC2341, GC9844, GD9052, GD9184,
GD9715, GD9724, GD9770;
J375H GD9067, GD9440, GD9681;
J376H GC9931, GD9068, GD9588;
J381H GC2353;
J416H GC2438, GC2439, GC9932, GC9933, GD9540,
GD9541, GD9542, GD9582;
J417H GC2366, GC2393;
J434H GD9165, GD9731;
J436H GD9186, GD9769;
J437H GC2354, GC9934, GD9543;
J527H GC2508, GD9448, GD9571;
J602H GC2382, GC9948, GD9578, GD9675, GD9709,
GD9730;
J603H GC2383, GD9080, GD9678, GD9755;
J849G GC9095;
J944H GC9994, GD9063, GD9565, GD9567;
J945H GC2557, GC9849;
J946H GD9066, GD9003, GD9520, GD9555, GD9556,
GC9969, GC9819;
J956H GD9774;
J957H GC9938;
J958H GC2345, GD9580, GD9581, GD9091.
(f) J516H GC2376, GD9710;
J517H GC2377, GD9077, GD9676, GD9192;
J518H GD9189, GD9434, GD9718;
J916H GD9455.
(g) J553G GC9996.
(h) J662H GC2441, GD9447, GD9742.
(i) All lots.
MANUFACTURER Ethicon, Inc., San Antonio, Texas and San Angelo, Texas.
RECALLED BY Ethicon, Inc., Somerville, New Jersey, by letters of September
10 and 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,527,088 boxes were distributed.
REASON The sterility of these lots of sutures cannot be assured
because of possible microorganism contamination during aseptic
processing, following sterilization.
-9- _______________
PRODUCT Kidney Perfusate Solution Concentrate, in 500 ml bottles, used
as a preservation solution for kidneys prior to implanting.
Recall #Z-023-5.
CODE All lots.
MANUFACTURER Geneva Laboratories, Inc./Preservation Solutions, Inc.,
Elkhorn, Wisconsin.
RECALLED BY Manufacturer, by letter September 8, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Washington, DC, New York, Florida, California.
QUANTITY 575 bottles were distributed.
REASON Product is a Class III device and does not have an approved
application for pre-market approval or an investigational
device exemption in effect.
_______________
PRODUCT Biopsy Guides for the 5C40 Transducer and C40 Transducer used
with the Quantum 2000 Ultrasound System. Recall #Z-025-5.
CODE All codes.
MANUFACTURER Siemens Medical Systems, Inc., Issaquah, Washington.
RECALLED BY Manufacturer, by letter dated September 2, 1994. Firm-
initialed field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 220 units were distributed.
REASON The device biopsy guide may not fit correctly on the bezel of
transducers causing slippage of the biopsy guide; resulting in
a biopsy sample being obtained outside the region of interest.
_______________
PRODUCT Extended Blade Electrodes, Catalog #809319, used as an
accessory to an electrosurgical panel.
Recall #Z-031-5.
CODE Lot numbers 2E1701 and 2B1183.
MANUFACTURER Edward Weck & Company, Research Triangle Park, North Carolina.
RECALLED BY Manufacturer, by letter June 18, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Australia, Canada, Spain.
QUANTITY 1,500 sales units.
REASON Some devices were found to have inadequate package seals which
may compromise the sterility of the device.
_______________
PRODUCT Cooley Dilators: (a) .5 mm, Catalog #355309;
(b) 1.0 mm, Catalog #355310; (c) 1.5 mm, Catalog #355311;
(d) 2.0 mm, Catalog #355312; (e) 2.5 mm, Catalog #355313;
(f) 3.0 mm, Catalog #355314; (g) Dilator Set of 6 sizes,
Catalog #355315. Recall #Z-034/040-5.
CODE Lot numbers: KK3 and BB4.
MANUFACTURER Krass USA, Inc., Hecker, Illinois
RECALLED BY Pilling Weck, Research Triangle Park, North Carolina, by
letter August 10, 1994. Firm-initiated recall ongoing.
-10- DISTRIBUTION Nationwide, Canada, France, Singapore.
QUANTITY 703 units were distributed.
REASON The dilators are breaking with excessive manipulation.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=======================
_______________
PRODUCT Toric Contact Lens, made to order lenses for use on
individuals with astigmatism: (a) Optima series;
(b) Criterion Ultra. Recall Z-011/012-5.
CODE Lot numbers: (a) SC267904, SC272946;
(b) SH269648, SH267904.
MANUFACTURER Bausch and Lomb, Inc., Sarasota, Florida.
RECALLED BY Bausch and Lomb, Inc., Rochester, New York, by letters dated
September 19, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 19 lenses were distributed.
REASON Each lot was incorrectly labeled with the product lot number
and power parameters.
_______________
PRODUCT Beckman Synchron CX7 Clinical Analyzer System, Part #756601,
indicated for in-vitro chemistry testing. Recall #Z-024-5.
CODE All units. All Serial numbers.
MANUFACTURER Beckman Instruments, Inc., Brea, California.
RECALLED BY Manufacturer, by letter April 22, 1994. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 996 units were distributed.
REASON Defective software may cause patient samples to be incorrectly
sampled, which may cause incorrect patient results to be
reported.
_______________
PRODUCT Software for the Electra 1000c, 900 and 900c Automated
Coagulation Timers. Recall #Z-027/029-5.
CODE All using software version 3.0 and declining numerical
versions.
MANUFACTURER Medical Laboratories, Inc., Pleasantville, New York.
RECALLED BY Manufacturer, by bulletin July 29, 1992 and October 5, 1992.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,954 instruments were distributed.
REASON Calculations associated with the "%" activity curve results
have been printed incorrectly during a test run with the
Electra 1000c. This could result in viewing the incorrect
curve results.
-11-
END OF ENFORCEMENT REPORT FOR OCTOBER 26, 1994. BLANK PAGES MAY
FOLLOW.
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