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.
June 3, 1998 98-22
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Chester's Flamin' Hot Fries, Corn & Potato
Snacks,
in 1 and 4 ounce bags. Recall #F-493-8.
CODE Sell by dates 14 APR, 21 APR, 28 APR, 05 MAY, 12
MAY, 19 MAY, 26 MAY, 02 JUN and 09 JUN
MANUFACTURER Frito-Lay, Inc., Topeka, Kansas;
Frito-Lay, Inc., Chamblee, Georgia.
RECALLED BY Frito-Lay, Plano, Texas, by hand-held
computer/communication devices, on April 7, 1998.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 6,232,272 bags were distributed; firm estimated
that 1,533,821 bags remained on market at time of
recall initiation.
REASON Product contains undeclared dairy products.
_______________
PRODUCT Pasteurized & Homogenized Liquid Egg Product,
packed 18-2.2 pound cartons per case.
Recall #F-494-8.
CODE MAY 22/98 1148, Use Thru/Lot No.
MANUFACTURER Vanderpol Eggs Ltd., Abbotsford, BC Canada.
RECALLED BY Golden State Food Corporation, Sumner, Washington
(distributor), by telephone beginning on May 6,
1998, followed by visits beginning on May 7, 1998.
Firm-initiated recall complete.
DISTRIBUTION Alaska, Washington state, Idaho, Montana.
QUANTITY 325 cases were distributed.
REASON Product was found contaminated with Salmonella C1.
_______________
PRODUCT Canned Cod (Codfish) Liver in Oil, net weight
300 g. Recall #F-495-8.
CODE All codes.
MANUFACTURER Euro-Industry, S.P. Szczecin, Poland.
RECALLED BY Kransnyi Oktyabr, Inc., USA, Brooklyn, New York,
by letter on April 16, 1998. Firm-initiated
recall complete.
DISTRIBUTION New York, New Jersey, Pennsylvania, Massachusetts,
Maryland, Ohio, Illinois, Georgia, Colorado,
Washington state.
QUANTITY 2,100 cartons (24 tins per carton) were
distributed; firm estimated that little product
remained on market at time of recall initiation.
REASON Product is a low acid canned food which was
manufactured without registration or process
filing as required by 21 CFR Part 108.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT a) Amoxicillin for Oral Suspension, USP, 125 mg
per 5 mL, 80, 100 and 150 ml when mixed, Rx
semisynthetic antibiotic, 125 mg/5 mL, NDC
#55953-149-38, -40, -47, also packaged under the
Major label, Distributed by Major Pharmaceuticals,
Livonia, MI, NDC #0904-2619-04, -07 and Qualitest
label, Distributed by Qualitest Pharmaceuticals,
Inc. Huntsville, AL, NDC #0603-6500-64, -66
b) Amoxcillin for Oral Suspension, USP, 250 mg per
5 mL, 80, 100 and 150 mL when mixed, 250 mg/5 mL,
NDC #55953-130-38, -40, -47, also packaged under
the Major label, NDC #0904-2620-04, -07, Rx
antibiotic. Recall #D-152/153-8.
CODE All lots within expiration date.
MANUFACTURER Novopharm Limited, Scarborough, Ontario, Canada.
RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by
letter dated May 8, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Amount distributed: a) 28,776 - 80-mL, 96,301
- 100-mL, 203,444 - 150-mL bottles;
b) 40,474 - 80- mL, 246,535 - 100-mL,
970,350 - 150-mL bottles.
REASON Lack of assurance of homogeneity.
_______________
PRODUCT Atenolol Tablets; a synthetic beta-selective
adrenoreceptor blocking agent for the management
of hypertension; packaged in 100 & 1000 tablet
bottles: a) 50 mg, NDC #55953-039-40, -80, also
packaged under the Major label, NDC #0904-7634-60,
-80, Rugby label, Mfd for Rugby Laboratories,
Inc., Norcross, Georgia, NDC #0536-3330-01, -10,
Qualitest label, NDC #0603-2371-21, -32, Martec
label, Mfd for Martec Pharmaceutical, Inc., Kansas
City, MO, NDC #52555-531-01, -10 and Mova label,
Mfd for Mova Pharmaceutical Corp., Caguas, PR
00725, NDC #55370-122-07
b) 100 mg, NDC #55953-401-40, also packaged under
the Rugby label, NDC #0536-3331-01, Qualitest
label, NDC #0603-2372-21, Martec label, NDC
#52555-534-01, and Moore label, Distributed by
Moore Drug Exchange, New Britain, Conn., NDC
#0839-7724-06. Recall #D-154/155-8.
CODE All lots within expiration date.
MANUFACTURER Novopharm Ltd., Scarborough, Ontario, Canada.
RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by
letter dated May 8, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Amount distributed: a) 67,459 100-tablet and
49,858 1000-tablet bottles
b) 225,873 100-tablet bottles.
REASON Lack of blend uniformity assurance.
_______________
UPDATE Recall #D-100/103-8, Propranolol HCL (Inwood
Laboratories, Inc., Inwood, New York), which
appeared in the April 1, 1998 Enforcement Report
has been extended to include 29 additional lot
numbers:
D-100-8: Propranolol HCl 60 mg Extended Release
(ER) Capsules, 100 count bottles, NDC #
0258-3609-01, 16 lots -- 7C003 (9/98), 7C004
(11/98), 7C005 (11/98), 7C017 (11/98), 7C018
(11/98), 7C019 (11/98), 7C021 (11/98), 7C022
(11/98), 7D007 (11/98), 7D008 (11/98), 7D009
(11/98), 7F042 (11/98), 7F043 (11/98), 7F044
(11/98), 7F045 (11/98) & 7F046 (11/98).
D-101-8: Propranolol HCl 80 mg ER Capsules, 100
count bottles, NDC # 0258-3610-01.
4 lots - 7C024 (3/99), 7C026 (3/99), 7D014 (3/99)
& 7F048 (5/99).
D-102-8: Propranolol HCl 120 mg ER Capsules, 100
count bottles, NDC # 0258-3611-01, 6 lots - 7C028
(3/99), 7C029 (3/99), 7F053 (5/99), 7F054 (5/99),
7F056 (8/99) & 7F057 (8/99).
D-103-8: Propranolol HCl 160 mg ER capsules, 100
count bottles, NDC # 0258-3612-01, 3 lots
- 7C033 (3/99), 7F058 (5/99) & 7F060 (5/99).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT a) OTO-Care (otic), Antipyrine 810 mg/Benzocaine
210 mg, 1/2 fluid ounce bottles, used for the
treatment of superficial infections of the
external auditory canal complicated by
inflammation caused by organisms susceptible to
the action of the antimicrobial, and is also
labeled to control itching; b) OTO Care HC (Otic)
Chloroxylenol USP 1 mg/Benzocaine 14 mg
Hydrocortisone, USP, 10 mg 1/2 fluid ounce
bottles, used to treat acute otitis media of
various etiologies. Recall #D-147/148-8.
CODE Lot numbers: a) F-2465 EXP 6/99;
b) F-2459 EXP 6/99.
MANUFACTURER Propharma, Inc., Miami, Florida.
RECALLED BY Manufacturer, by a) telephone followed by fax on
April 3, 1998; b) by telephone and fax on May 4,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY Approximately 6,760 bottles were distributed.
REASON Stability - Accelerated stability testing failures
for benzocaine/hydrocortisone in OTO care HC and
antipyrine/benzocaine in OTC care.
_______________
PRODUCT Neomycin and Polymyxin B Sulfate and
Hydrocortisone Otic Solution, USP (Neomycin
sulfate, equivalent To 3.5 mg Neomycin
base/Polymyxin B Sulfate 10,000
units/Hydrocortisone 10 mg), 10 mL bottles of 30,
used for otic use only, under the following
labels: Schein Pharmaceutical, Steris Laboratories
Inc., Akorn, Carlisle, Erva, Fougera, Geneva,
Generics of Puerto Rico, Goldline, IDE, H. L.
Moore, Major, Marlop Pharmaceuticals Inc., Mason,
Parmed, Robar Inc., Rugby, Teral, Teva, and United
Research Laboratories. Recall #D-149-8.
CODE 95C960, 95C961, 95D370, 95D371, 95D420, 95D620,
95D950, 95D951, 95D970, 95E040, 95E260, 95E410,
95E790, 95E990, 95F380, 95F570, 95G200, 95G450,
95G830, 95H020, 95H021, 95H640, 95H880, 95H881,
95J070, 95J120, 95L240, 95L820, 96A360, 96A490.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letter on March 18, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 2,230,007 bottles were distributed; firm estimated
that 16,000 bottles remained on the market at time
of recall initiation.
REASON Stability - Lack of data at labeled storage
conditions.
_______________
PRODUCT Piroxicam Capsules, USP; for acute or long-term
use in the relief of signs and symptoms of
osteoarthritis and rheumatoid arthritis; packaged
in bottles of 100, 500 & 1000 capsules: a) 10
mg,
NDC #55953-617-40
b) 20 mg, NDC #55953-640-40, -70, -80 also
packaged under the Moore label, NDC #0839-7774-06,
-16; Major label, NDC #0904-5063-60, -40; and Mova
label, NDC #55370-841-07. Recall #D-156/157-8.
CODE All lots within expiration date.
MANUFACTURER Novopharm, Ltd., Scarborough, Ontario, Canada.
RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by
letter dated May 8, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Amount distributed: a) 15,390 100-capsule
bottles; b) 52,366 100-capsule, 14,892 500-capsule
and 5,147 1000-capsule bottles.
REASON Lack of blend uniformity assurance.
_______________
PRODUCT Various K.W. Botanicals brand OTC products:
a) Achillea & Symphytum 16 Salve (Achillea,
Symphytum, Calendula, Hypericum, Mahonia,
Plantago, Salvia, Prunella...), in 1 fluid ounce
glass bottles, OTC product; b) Thyme & Tea
Tree 16
Oil (Plantago, Mahonia, Symphytum, Echinacea,
Larrea, Calendula, Oils, Vitamin E, Avocado,
Thyme, Tea Tree, Bay, Eucalyptus, Rue, Camphor,
Clove, Gum Arabic), in 1/8 ounce glass bottles,
for external use only; c) Thyme & Tea Tree 17
Oil
(Plantago, Mahonia, Symphytum, Echinacea, Larrea,
Calendula, Oils; Vitamin E, Avocado, Thyme, Tea
Tree, Bay Eucalyptus, Rue, Camphor, Clove, Gum
Arabic), in 1/8 ounce glass bottles, for external
use only. Recall #D-158/160-8.
CODE Lot numbers: a) 4/97; b & c) none.
MANUFACTURER K. W. Botanicals, San Anselmo, California.
RECALLED BY Manufacturer, by letter on July 28, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY a) 41 bottles; b) 4 1-dram bottles; c) 40 1-dram
bottles.
REASON Contamination - One bulk ingredient was detected
to contain Lanatosides.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ===========
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma.
Recall #B-1128/1131-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by telephone on November 26, 1997,
and/or by letter dated December 12, 1997, and by
fax on December 2, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois, Minnesota, Kentucky, Massachusetts,
Maryland, Pennsylvania, California.
QUANTITY a) 25 units; b) 20 units; c) 5 units; d) 22 units
were distributed.
REASON Blood products may have been collected in a manner
that could compromise the sterility of the
products.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma.
Recall #B-1167/1170-8.
CODE Unit numbers: 22389-4838, 22389-4832, 22389-2275,
22389-2266 22389-2575, 22390-4631, 22390-5393,
22390-4614, 22390-9566, 22390-9551, 22390-9560,
22390-0565, 22390-7819, 22389-5184, 22390-8386,
22390-7878, 22390-3346.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Manufacturer, by letters between March 20, 1997
and August 1, 1997, and May 9 and 19, 1997, and
September 12, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nevada, New York, Switzerland.
QUANTITY a) 3 units; b) 2 units; c) 7 units; d) 10 units
were distributed.
REASON Blood products were collected from donors whose
screening for high risk behavior was inadequately
performed.
_______________
PRODUCT a) Red Blood Cells; b) Single Donor Plasma;
c) Red Blood Cells, for further manufacture;
d) Recovered Plasma. Recall #B-1171/1174-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated September 1, 1997,
October 1, 1997, November 20, 1997, February 5,
1998, and March 10, 1998. Firm-initiated recall
complete.
DISTRIBUTION Illinois and California.
QUANTITY a) 16 units; b) 3 units; c) 4 units; d) 19 units
were distributed.
REASON Blood products 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.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ==========
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1136/1137-8.
CODE Unit #17FZ00520.
MANUFACTURER American Red Cross Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by telephone on February 20, 1998.
Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
reported a post donation sore throat, were not
quarantined, and were distributed after receipt of
the information.
_______________
PRODUCT Reagent Red Blood Cells, Panocell-10; and Reagent
Red Blood Cells, Panocell-10, Ficin Treated.
Recall #B-1166-8.
CODE Reagent Red Blood Cells, Panocell-10, Lot 04587,
and Reagent Red Blood Cells, Panocell-10, Ficin
Treated, Lot 04587E.
MANUFACTURER Immucor, Inc., Norcross, Georgia.
RECALLED BY Manufacturer, by letter dated January 26, 1998.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 507 kits (Lot #04587) and 187 kits (lot #0487E).
REASON Reagent Red Blood Cells, incorrectly identified as
f negative on the accompanying master list,
Problem: Reagent Red Blood Cells, incorrectly
identified as f negative on the accompanying
master list.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =============
_______________
PRODUCT National Medical Care brand Venous Hemodialysis
Bloodlines. Recall #Z-582-8.
CODE Catalog No. 03-7317-5, Lot Nos. R7J001, R7J002 and
R7J004.
MANUFACTURER Fresenius Medical Care North America, Lexington,
Massachusetts.
RECALLED BY Fresenius Medical Care North America, Renal
Product Technologies, Lexington, Massachusetts, by
letter on April 29, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,595 cases (24 units per case) were distributed.
REASON There is a possibility that a portion of the lots
were not processed according to validated
sterilization cycle, therefore, compromising the
sterility of the bloodlines.
_______________
PRODUCT Apnea slow breath and heart rate monitors:
a) Assurance 2000 Heart/Respiration Monitor
b) Assurance 2000 Hospital Monitor.
Recall #Z-583/584-8.
CODE Model Number Serial Number
2000WH 7057
A-2000 11935***
*** = 077, 562, 565 through 595, 597
through 621, 624, 627, 629
through 640, 642 through 648,
651, 653, 655, 658 through 691,
696, 701, through 706, 708
through 777, 779 through 819,
821 through 853, 855 through 999
11936***
*** = 000 through 048, 051 through
086. 088 through 116, 118, 119,
121 through 133, 135 through
217, 219 through 221, 223
through 247, 249 through
252, 254 through 290, 292, 294
through 311, 313 through 375,
377 through 381, 384 through
386, 388 through 393, 395
through 418, 420 through 433,
435 through 456, 458 through
483, 485 through 579, 582, 584
through 594, 596, 597, 598,604
through 666, 668, 670 through
681, 683 through 703, 705
through 715, 717 through 731,
733, 734, 735, 737, 738, 740,
741, 742
11938***
*** = 830, 832, 865, 870, 871, 874
33495
A2000H 8890 through 8901, 8906, 8907,
8908, 8910 through 8913.
MANUFACTURER Nellcor Puritan Bennett, Inc., Minneapolis,
Minnesota.
RECALLED BY Manufacturer, by letter dated May 13, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,143 devices were distributed.
REASON Contaminated circuit boards could cause a product
malfunction. The devices could fail to alarm,
when an alarm is appropriate to warn of apnea or
abnormal heart rate.
_______________
PRODUCT Bipolar Rx Pacing Leads, intended for use with
pulse generators for long-term cardiac pacing.
Recall Z-585-8.
CODE All leads manufactured since 1983.
MANUFACTURER Aulzer Oscor, Inc. (Formerly Oscor Medical
Corporation), Palm Harbor, Florida.
RECALLED BY Manufacturer, by letter mailed beginning April 20,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 21,000 leads were distributed.
REASON The polyurethane insulation of the device is
cracking resulting in higher than normal failure
rates.
_______________
PRODUCT R.S.V. Collection Kit, Nasal Washing Kit and Would
Care Tray:
a) Centurion Hospital Products brand Latex Free
Nasal Washing Kit, Reorder #RSV1525
b) Centurion Hospital Products brand R.S.V.
Collection Kit, Reorder #S2070.
c) Centurion Hospital Products brand Wound Care
Tray, Reorder # WT1180. Recall #B-588/590-8.
CODE Lot numbers: a) S11037, S01198 and S03098
b) S01058; c) 12166, 12026, 04287, 06097, 06167,
06307, 09157, 09297, 10137, M11037, M11247,
M12157, and M02028.
MANUFACTURER Kendall Healthcare Products Company, Mansfield,
Massachusetts (component).
RECALLED BY Tri-State Hospital Supply Corporation, Howell,
Michigan.
DISTRIBUTION California, Georgia, Iowa, Minnesota, Nebraska,
Texas, Virginia.
QUANTITY Amount Dist. Estimated in Marketplace
a) 900 less than 200
b) 100 0
c) 19,140 less than 4,020
REASON contain sodium chloride solution which is labeled
as sterile which is contaminated with Ralstonia
pickettii (formerly referred to as Pseudomonas
pickettii), an opportunistic pathogen.
_______________
PRODUCT Companion CR50 Conserving Oxygen Regulators,
designed to be used with high-pressure oxygen
cylinders to conserve oxygen and is both a regular
and conserving device: a)Companion CR50 Conserving
Oxygen Regulators, Part 134220-01, b) Companion
R50 Conserving Oxygen Regulators, Part 134221-01,
CODE Lot Numbers: a) 741A, 745A, 751A, 803A; b) 745A.
MANUFACTURER Nellcor Puritan Bennett, Inc., Lenexa, Kansas.
RECALLED BY Manufacturer, by letter dated April 14, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Japan.
QUANTITY 1,025 units were distributed.
REASON The units have a potential for a no flow condition
during operation caused by a gasket associated
with the pressure relief valve of the regulator.
RECALLS AND FIELD CORRECTIONS: DEVICES CLASS III="==========="
_______________
PRODUCT B.E.C. Growth Chek Microbial Suspension of
Bacillus, used for quality control testing of
culture media per USP Growth Promotion testing and
Bacteriostasis/Fungistasis Testing methods. Recall
#Z-561-8.
CODE Lot #012798 EXP 7/27/98.
MANUFACTURER Biological & Environmental Control Laboratories,
Inc., doing business as B.E.C. Laboratories, Inc.,
Toledo, Ohio. RECALLED BY Manufacturer, by letter
on April 30, 1998. Firm-initiated recall ongoing.
DISTRIBUTION New York, Illinois, Nebraska, New Mexico, Rhode
Island, Indiana, Pennsylvania. QUANTITY 18 vials
were distributed. REASON The population of
bacterial suspension has dropped to less than the
labeled population, resulting in failure to meet
labeled shelf life.
_______________
PRODUCT Revolution Flowable Light Cure Dental Composite,
used for permanent tooth fillings. Recall
#Z-580-8.
CODE The product part numbers are:
28289, 28290, 28660, 28793, 450100, 450102,
450104, 450139.
Lot numbers within these part numbers:
709170, 709680, 709789, 710036, 710195, 710372,
710387, 710528, 710577, 710672, 711059, 711085,
711182, 711256, 711303, 711329, 711330, 711339,
711445, 712072, 712083, 712565, 801254, 801405,
803071, 803156, 803366.
MANUFACTURER Scientific Pharmaceuticals, Inc., Pomona,
California.
RECALLED BY Kerr Corporation, subsidiary of Sybron Dental
Specialties, Inc., Orange, California, by letter
on April 1, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 62,254 syringes were distributed.
REASON The resin does not set completely after curing.
_______________
PRODUCT Polymyxin B Sulfate, USP, Catalog #0319, received
in 135 bulk bottles and is repackaged and
distributed under the Amresco label. Firm believes
that this product is used as an ingredient for
making tissue culture media and biological growth
media, or as an ointment placed on a bandage, or
as a semen extender. Recall #Z-581-8.
CODE Lot #1987A13 EXP 12/31/01.
MANUFACTURER Pfizer, Inc, Groton, Connecticut (responsible
firm).
RECALLED BY Amresco, Inc., Solon, Ohio (repacker), by letter
on April 29, 1997. Firm-initiated recall complete.
DISTRIBUTION Maine, Massachusetts, Pennsylvania, Arizona,
California, Missouri, Ohio, Hong Kong, Shang-Hi,
Japan.
QUANTITY 36 bottles were distributed.
REASON The label has an incorrect potency value.
_______________
PRODUCT Centurion Hospital Products brand Pelvic Exam
Tray, Reorder #PE2255. Recall #Z-591-8.
CODE Lot numbers: S05197, S07077, S08257, S09157,
S10207, S02028, S03098.
MANUFACTURER Kendall Healthcare Products Company, Mansfield,
Massachusetts (component).
RECALLED BY Tri-State Hospital Supply Corporation, Howell,
Michigan, by telephone or fax on April 21, 1998,
and by letter dated April 21, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION California, Georgia, Iowa, Minnesota, Nebraska,
Texas, Virginia.
QUANTITY 4,840 units were distributed; firm estimated that
less than 600 units remain on the market.
REASON Device contains sodium chloride solution which is
labeled as sterile which is contaminated with
Ralstonia Pickettii (formerly referred to as
Pseudomonas pickettii), an opportunistic pathogen.
_______________
PRODUCT MLA Electra Automated Coagulation Testing
Instruments, used to provide data on blood
clotting and factor assays: a) Model E900C (Part
No. 1095C), b) Model E1000C (Part No. 1096C).
Recall #Z-597/598-8.
CODE Serial Numbers: a) 3645 thru 3675; b) 3524-2010,
3523-2011, R001-R001, R004-R004 through R040-R040.
MANUFACTURER Medical Laboratory Automation (MLA), Inc.,
Pleasantville, New York.
RECALLED BY Manufacturer, by letter on April 23, 1998.
Firm-initiated field correction ongoing.
DISTRIBUTION New York, New Jersey, Maryland, Virginia, West
Virginia, Tennessee, Florida, Illinois, Michigan,
Texas, Oklahoma, Arizona, California.
QUANTITY a) 31 units; b) 38 units were distributed.
REASON The video boards are not compatible with the
central processing unit.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS CLASS II="=="
_______________
PRODUCT ChlorhexiDerm Scrub 2% Chlorhexidine, antiseptic
antimicrobial surgical scrub. Recall #V-023-8.
CODE Lot Numbers: 7347 and 7347A.
MANUFACTURER DVM Pharmaceuticals, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter dated April 21, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,160 gallons were distributed; firm estimated
little product remained on market at time of
recall initiation.
REASON Product analyzed and tested positive for Serratia
marcescens and Pseudomonas aeruginosa.
_______________
PRODUCT Radix Labs Milk Fever K Sterile, nonpyrogenic (for
the treatment of milk fever in cattle), in 500 ml
bottles. Recall #V-024-8.
CODE Lot numbers R6P010 EXP 11/98.
MANUFACTURER Radix Laboratories, Inc., Eau Claire, Wisconsin.
RECALLED BY Manufacturer, by letter dated May 11, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Minnesota, Wisconsin, Illinois and Iowa
QUANTITY 1,850 500-ml bottles were distributed.
REASON Precipitate found in the injectable product at 18
month check (product has 2 year expiration
dating).
RECALLS AND FIELD CORRECTIONS VETERINARY PRODUCTS: CLASS III
_______________
PRODUCT Nutrena Chick Starter-Grower with Amprolium and
Ethopabate, type C medicated feed (for coccidiosis
prevention). Recall #V-025-8.
CODE Lot # F8089.
MANUFACTURER Cargill Feed Division, Nutrena Feeds Division,
Flora, Illinois.
RECALLED BY Manufacturer, by telephone on April 15, 1998.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 225 bags were distributed.
REASON The medicated feed was manufactured with the wrong
Type A medicated article. The Ethopabate active
drug ingredient was left out at manufacture.
END OF ENFORCEMENT REPORT FOR JUNE 3, 1998.
####
![[FDA
HOME PAGE]](https://webarchive.library.unt.edu/eot2008/20081007023342im_/http://www.fda.gov/icon/iconhome.gif)