September 4, 2002
02-35
_______________________
PRODUCT
SUPREME QUALITY brand PICKLED Sour
bamboo shoot (SLICE) packed in glass
jars, NET WT. 29.89 OZ. ING: Bamboo,
Water, Salt. PRODUCT OF THAILAND.
Barcode #84909 00343. Recall # F-746-2.
CODE
All products on the market at the
time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hong Thai Foods Corp.,
Brooklyn, NY, by press release on
February 14, 2002.
Manufacturer: Savoy Enterprises Ltd.,
Part. Yannawa, Bangkok.
State initiated recall is complete.
REASON
The New York State Department of
Agriculture and Markets found the
product to contain undeclared sulfites
(390 ppm).
VOLUME OF PRODUCT IN COMMERCE
23 cases (12 jars per case).
DISTRIBUTION
NY and NJ.
_______________________
PRODUCT
Caravelle brand, Pickled Sour Bamboo
Shoot Slices, 2 pound and 4 pound
jars. Recall # F-747-2.
CODE
All products on the market at the
time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Anhing Corporation,
Los Angeles, CA, by letter on July
2, 2002. The New York State Department
of Agriculture and Markets issued
a press release on June 27, 2002.
Manufacturer: Unknown. State initiated
recall is ongoing.
REASON
The New York State Department of
Agriculture and Markets found the
product to contain 781 ppm undeclared
sulfites in 35g serving size.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Pure Fun brand Peach Mango Juice
Blend Concentrate,1+7, in half gallon
bottles. Recall # F-748-2.
CODE
Lot 110702.
RECALLING FIRM/MANUFACTURER
Penguin Juice Company, Westland,
MI, by telephone on July 29, 2002
and by letter on August 1, 2002.
FDA initiated recall is complete.
REASON
The product contained undeclared
FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
50 cases (6 bottles per case).
DISTRIBUTION
GA.
_______________________
PRODUCT
Laima brand Greipfrutu Skelites
(Grapefruit Candy). Recall # F-749-2.
CODE
Lot No. L01012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Romic Inc., Alpharetta,
GA, by telephone on June 13, 2002.
Manufacturer: JSC Laima Riga, Latvia.
State initiated recall is ongoing.
REASON
The product contained the unapproved
food color Ponceau 4R.
VOLUME OF PRODUCT IN COMMERCE
640 cartons.
DISTRIBUTION
NY.
_______________________
PRODUCT
Miguel and Valentino brand Fig
Cake, Hand Made, packaged in cellophane
wrap and further packaged in wraparound
wicker basket, net wt. approx 2 lbs.
Recall # F-750-2.
CODE
Lots 14922, 23206, 25093, 27205.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Miguel and Valentino,
Bethesda, MD, by press release on
June 6, 2002.
Manufacturer: Victoriano Navas Martin
Zorilla Archez (Malaga) Spain. State
initiated recall is complete.
REASON
Product contained undeclared almonds
which were visible on the top of
the cake.
VOLUME OF PRODUCT IN COMMERCE
672 cakes.
DISTRIBUTION
CO, FL, GA, MD, D.C., MI, CA and
NJ.
_______________________
PRODUCT
Zerit (stavudine) Capsules, 40
mg, bottles of 60, Rx only. Recall
# D-398-2.
CODE
Lot 1A36209, Exp. FEB 2003.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alliance Wholesale
Distributor, Richton Park, IL, by
letter dated June 28, 2002.
Manufacturer: Bristol-Myers Squibb
Oncology/Immunology, Princeton, NJ.
Firm initiated recall is ongoing.
REASON
Tablets changed to capsules.
VOLUME OF PRODUCT IN COMMERCE
26 bottles.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Quinaglute (quinidine gluconate,
USP), Dura-Tabs (extended-release
tablets, USP) 324 mg, 100 count bottles,
Rx only. Recall # D-399-2.
CODE
Lot #012634, Exp. OCT 23 03
Lot #012831, Exp. NOV 27 03
Lot #012263, Exp. SEP 04 03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AmeriSource Health
Services Corp., Columbus, OH, by
letter and fax on August 20, 2002.
Manufacturer: Berlex Laboratories,
Wayne, NJ. Firm initiated recall
is ongoing.
REASON
Metal particles found in tablet (by
manufacturer).
VOLUME OF PRODUCT IN COMMERCE
687 bottles total.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Nasonex Nasal Spray (mometasone
furoate monohydrate) 50 mcg, Net
Contents: 17 g, 120 Metered Sprays,
FOR INTRANASAL USE ONLY. Rx only.
Recall # D-400-2.
CODE
1-KTL-147 Exp. date 3.03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering Corpration,
Kenilworth, NJ, by fax on an unknown
date and by letters on August 12,
2002.
Manufacturer: Schering-Plough Products,
Inc., Manati, Puerto Rico. Firm initiated
recall is ongoing.
REASON
Defective container; missing part
in actuator may cause a narrow stream
of product to be dispensed rather
than a fine spray
VOLUME OF PRODUCT IN COMMERCE
295,620 units.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Human Tissue for Transplantation
of the following types. Recall #
B-1789-2.
a) Skin, Meshed
b) Skin (sq.ft.)
c) Tibia
d) Achilles Tendon with Bone
e) Patellar Ligament; with Quadriceps
f) Patellar Ligament
g) Ilium, Hemi
h) Fibula, Segment
i) Tri-Cortical Block
J) Cortical Wedge Select
k) Fibula, Ring
l) Cancellous, Crushed
m) Cancellous Block
n) Cancellous, Crushed
CODE
a) Tissue ID # CTSP000348-009, CTSP000348-010,
CTSP000348-011, CTSP000348-012,
CTSP000348-013, CTSP000348-014.
b) Tissue ID # CTSP000348-015, CTSP000348-016.
c) Tissue ID # CTSP000348-017.
d) Tissue ID # CTSP000348-018, SP000348-019.
e) Tissue ID # CTSP000348-020.
f) Tissue ID # CTSP000348-021.
g) Tissue ID # CTSP000348-022.
h) Tissue ID # CTSP000348-023, CTSP000348-024.
i) Tissue ID # CTSP000348-032.
j) Tissue ID # CTSP000348-033, CTSP000348-034,
CTSP000348-035, CTSP000348-036, CTSP000348-037,
CTSP000348-038, CTSP000348-039,
CTSP000348-040, CTSP000348-041.
k) Tissue ID # CTSP000348-044, CTSP000348-046, CTSP000348-050.
l) Tissue ID # CTSP000348-053, CTSP000348-054,
CTSP000348-055, CTSP000348-056,
CTSP000348-057, CTSP000348-058,
CTSP000348-059, CTSP000348-060, CTSP000348-061,
CTSP000348-062.
m) Tissue ID # CTSP000348-063, CTSP000348-064,
CTSP000348-065, CTSP000348-066, CTSP000348-067,
CTSP000348-068, CTSP000348-069,
CTSP000348-070, CTSP000348-071,
CTSP000348-072, CTSP000348-073,
CTSP000348-074, CTSP000348-075,
CTSP000348-076,
CTSP000348-077, CTSP000348-078,
CTSP000348-079.
n) Tissue ID # CTSP000348-080, CTSP000348-081,
CTSP000348-082.
RECALLING FIRM/MANUFACTURER
Community Blood Center, dba: Community
Tissue Services (CTS), Dayton, Ohio,
by letters dated July 15, 2002 and
July 25, 2002.
Firm initiated recall is ongoing.
REASON
Tissue for transplantation, processed
from a donor who tested positive
for hepatitis C virus (HCV) subsequent
to distribution.
VOLUME OF PRODUCT IN COMMERCE
59 units.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced,
Recall # B-1788-2.
CODE
Units 04KS64220, 04G25447.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region,
Dedham, MA, by letter dated May 7,
2002. Firm initiated recall is complete.
REASON
Blood products, collected from a
donor who had lived in an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.
_______________________
PRODUCT
Platelets, Pheresis, Leukocytes
Reduced, Recall # B-1818-2
CODE
Unit 04GS06136.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New
England Region, Dedham, MA, by
telephone on May 13, 2002, and letter
dated May 28, 2002.
Firm initiated recall is complete.
REASON
Blood product, inappropriately prepared
in that the product was distributed
in one platelet bag instead of two,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-1820-2.
CODE
Unit S12185.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by
letter dated November 2, 2000.
Firm initiated recall is complete.
REASON
Blood product, which tested non-reactive
for antibody to the hepatitis B core
antigen (anti-HBcore), but was collected
from a donor who previously tested
reactive on two prior occasions,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________
PRODUCT
Source Plasma, Recall # B-1833-2.
CODE
Units 0015331, 0015469, 0015654.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Hot Springs, Inc.,
Plasmapheresis Facility, Hot Springs
AK, by fax on February 11, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from
a donor who tested reactive for hepatitis
B surface antigen (HbsAg), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Austria.
______________________
PRODUCT
Red Blood Cells, Leukoreduced,
Recall # B-1834-2.
CODE
Units 50C19470, 50C19479, 50C19554,
50LG55918, 50C19378, 50C19350, 50LG55838,
50C19960, 50C19973, 50C19976, 50C20073,
50C23477, 50LG58467, 50LG58471, 50LG58483,
50LG57697, 50C23668, 50C23712, 50C23713,
50LH24269, 50LJ36051, 50LJ36210,
50LJ36248, 50C24394.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western
Lake Erie Region, Toledo, OH, by
letter dated December 4, 2001 or
February 6, 2002.
Firm initiated recall is complete.
REASON
Blood products, which were incorrectly
tested for Cytomegalovirus (CMV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
OH.
_______________________
PRODUCT
Platelets Pheresis, Recall #
B-1857-2.
CODE
Unit number R52990.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial
Blood Center, Bethlehem, PA, by letter
on August 8, 2000. Firm initiated
recall is complete.
REASON
Platelets with a decreased platelet
count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________
PRODUCT
Platelets Pheresis, Recall #
B-1858-2.
CODE
Unit number R52937.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial
Blood Center, Bethlehem, PA, by letter
on July 20, 2000. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor
that did not answer one of the medical
history questions concerning behavior
known to increase risk of infection
with the human immunodeficiency virus
(HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________
PRODUCT
Source Plasma, Recall # B-1707-2.
CODE
Units 46 DCDYDG 0, 46 DCCWXG 0.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Decatur,
IL, by fax on February 22, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from a
donor with an elevated temperature
and whose health history was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________
PRODUCT
Platelets, Pheresis, Recall #
B-1816-2.
CODE
Unit R79836.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, t/a Miller Memorial
Blood Center, Bethlehem, PA, by telephone
on August 6, 2001 and by letter dated
September 14, 2001. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor
whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced,
Recall # B-1819-2.
CODE
Unit 12GY49326.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Carolinas
Region, Charlotte, NC, by telephone
on May 29, 2002 and by letter dated
June 11, 2002. Firm initiated recall
is complete.
REASON
Blood product, which had a positive
antibody screening test, but labeled
as negative for unexpected antibodies,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced,
Recall # B-1821-2.
CODE
Unit G46085.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Rockford,
IL, by telephone on June 6, 2002.
Firm initiated recall is complete.
REASON
Blood product, which was incorrectly
tested for anti-HTLV I/II, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________
PRODUCT
Fresh Frozen Plasma, Recall #
B-1855-2.
CODE
Unit number 6745504.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Children's
Memorial Hospital, Chicago, IL, by
telephone on February 22, 2002 and
by letter dated March 27, 2002. Firm
initiated recall is complete.
REASON
Blood product, that was not frozen
within 8 hours of collection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced,
Recall # B-1856-2.
CODE
Unit numbers 6745708, 6746142, 6746143,
6746145, 6746146, and 6746147.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Children's
Memorial Hospital, Chicago, IL, by
telephone on February 21, 2002 and
by letter dated March 27, 2002. Firm
initiated recall is complete.
REASON
Blood products, that did not have
the additive solution included within
the time frames specified by the
manufacturer's instructions, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL.
_______________________
PRODUCT
Red Blood Cells, Recall # B-1859-2.
CODE
Unit numbers T30834, T30836, and
T30841.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial
Blood Center, Bethlehem, PA, by telephone
on April 19, 2000. Firm initiated
recall is complete.
REASON
Unlicensed blood products were distributed
interstate.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NJ.
****CORRECTION****
Recall # Z-1152-2/Z-1154-2 on
Enforcement Report 02-30 had the
incorrect manufacturer listed. The
correct manufacturer is: Angeion
Corp., Minneapolis, MN.
_______________________
PRODUCT
Sterile Laceration Tray, product
code 50-10890, packaged in sterile
tray, 30 trays\case. Recall # Z-1269-2.
CODE
Lot number 324580.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Deroyal Industries,
Inc., Powell, TN, by letter on March
19, 2002.
Manufacturer: Deroyal Wound Care,
Rose Hill, VA. Firm initiated recall
is complete.
REASON
Defective seals on surgical trays
compromise device sterility.
VOLUME OF PRODUCT IN COMMERCE
90 trays.
DISTRIBUTION
GA.
_______________________
PRODUCT
Buffered Iontophoretic Delivery
Electrode System, non-sterile, single-use
only, packaged in a metalized mylar
bag, 12 per box.
IO-Drive Iontophoresis Electrode
System. Recall # Z-1271-2.
The product consists of 1 active
drug delivery electrode, 1 return
electrode, 1 or 2 alcohol swabs,
and an instruction manual. The device
is sold as a kit that is non-sterile
and intended for single-use only.
The kits contain one of three sizes
of the active electrode (small, medium,
or large).
The medical device is sold under
the 'Selective Med Components' label
and several private labels as follows:
1) Buffered Iontophoretic Delivery
Electrode System; North Coast Medical,
Inc.
2) Buffered Iontophoretic Delivery
Electrode System, EMSI, Tampa, Florida.
3) Buffered Iontophoretic Delivery
Electrode System; MedPend, Inc.,
Lake Mary, FL.
4) Buffered Iontophoretic Delivery
Electrode System; Rudolph Medical.
5) Buffered Iontophoretic Delivery
Electrode System; Physio Tech.
6) Buffered Iontophoretic Delivery
Electrode System;
Spectramed.
7) IoDOSE Buffered Iontophoretic
Delivery Electrode System;
MagMed, Inc.
8) SUPER-TRODES Buffered Iontophoretic
Delivery Electrode
System; SME, Inc.
9) Buffered Iontophoretic Delivery
Electrode System; Selective
Med Components.
10) IONTO-Clone Buffered Iontophoretic
Delivery Electrode System; New England
Surgical, Inc.
CODE
Lot Numbers: 5129-1, 5130-1, 5131-1,
5291-1, 5292-1, 5293-1, 5368-1, 5369-1,
5370-1, 5573-1, 5574-1, 5575-1, 5684-1,
5685-1, 5686-1, 5946-1, 5947-1, 5948-1,
6483-1, 6484-1, 6487-1, 6711-1, 6712-1,
6713-1, 7030-1, 7031-1, 7032-1, 7427-1,
7428-1, 7429-1, 7513-1, 7514-1, and
7515-1.
RECALLING FIRM/MANUFACTURER
Selective Med Components, Inc., Mt.
Vernon, OH, by recall notice on July
18, 2002. FDA initiated recall is
ongoing.
REASON
The device may cause skin burns.
VOLUME OF PRODUCT IN COMMERCE
70,000 kits.
DISTRIBUTION
FL, MS, OH, MA, CA, VA, and NC.
_______________________
PRODUCT
Storz brand Concentrix Phacoemulsification
Pack, Labeled as Sterile. Product
or reference number CX4310. Recall
# Z-1270-2.
CODE
Lot Number: S7825.
RECALLING FIRM/MANUFACTURER
Bausch & Lomb Surgical, Inc.,
Clearwater, FL, by letter on May
10, 2002. Firm initiated recall is
ongoing.
REASON
Irrigation line tubing may not properly
adhere to the casette and leak or
detach.
VOLUME OF PRODUCT IN COMMERCE
600 (100 boxes/6 units each).
DISTRIBUTION
Nationwide and Australia, Canada
and The Netherlands.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 4, 2002
####
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