The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
December 25, 2002
02-51
_____________________________
PRODUCT
RED DIAMOND brand Wintermelon Strip, N.W. 12 oz. (340 g), packaged in heat-sealed
plastic bags.
bIngr.: Wintermelon, Sugar. Product of China. Recall # F-103-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Starway Inc., Brooklyn, NY, by press release on June 19, 2002.
Manufacturer: Sun Wing Hong Food Limited, Hong Kong, China. State initiated
recall is complete.
REASON
The product contained undeclared sulfites (1600 ppm).
VOLUME OF PRODUCT IN COMMERCE
1 case (50 - 12 oz. packages per case) was distributed.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Pimento Cheese Sandwiches, 4.5 oz, packaged under the VIP
FOOD SERVICE label.
The label states in part, "PIMENTO CHEESE SANDWICH ** Ingredients: (cheese,
pimento, salad dressing, enriched br ** KEEP REFRIGERATED ** Net Wt 4.5 ox (127g).
Recall # F-104-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
International Vending, Inc., Louisville, KY, by telephone on October 17&
18, 2002. Firm initiated recall is complete.
REASON
Sandwiches contained undeclared ingredients including egg yolks.
VOLUME OF PRODUCT IN COMMERCE
58 sandwiches.
DISTRIBUTION
KY.
_____________________________
PRODUCT
EASTWELL brand DRIED DATE packaged in a flexible plastic bag, NET WT. 12 oz.
(340 g). PRODUCT OF CHINA. Recall # F-105-3.
CODE
Barcode # 911749 380497, "EXPIRATIONO: 24 MONTHS"
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eastwell Trading Corp., Brooklyn, NY, by salemen visit on September
4, 2002.
Manufacturer: Jiangman Food I/E Co., Guangdong, China. State initiated recall
is complete.
REASON
The product contained undeclared sulfites (275 ppm).
VOLUME OF PRODUCT IN COMMERCE
24 cases (50 - 12 oz. packages per case) were distributed. The recalling firm
recovered approx. 16 cases from the retail level, which were destroyed at the
firm's warehouse.
DISTRIBUTION
NY.
_____________________________
PRODUCT
KLEIN'S NATURALS brand fancy mix fruity deluxe in sealed, clear, rigid plastic
containers, net wt. 8 oz. Recall # F-106-3.
Barcode #: 40312 20880
Ingredients: Pineapple, Papaya, Black & Gold Raisins, Banana, Craisins (Cranberries),
Apples.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Klein's Naturals, Ltd., Brooklyn, NY, by press release on March 14, 2002. State
initiated recall is complete.
REASON
The product contained undeclared sulfites (480 ppm).
VOLUME OF PRODUCT IN COMMERCE
206 cases (6 - 8 oz. packages per case); 314 - 8 oz. units were recovered &
destroyed by the recalling firm.
DISTRIBUTION
NY, NJ, PA, MA, CT, DE, CA and FL.
_____________________________
PRODUCT
Sage, 2 oz plastic bottles. Brand Label: Spice It. Recall # F-107-3.
CODE
Lot "0101" and "02107"
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spice It, Lakewood, NJ, by letters on June 26, 2002 and by press
release on July 5, 2002. Firm initiated recall is complete.
REASON
The product was contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,950 lbs.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Children's Tylenol (Acetaminophen) Oral Suspension,
160 mg, 4 Fl oz (120mL) bottles, Bubblegum Flavor,
NDC #50580-407-04. Recall # D-096-3.
b) Children's Tylenol (Acetaminophen) Oral Suspension,
160mg, 4 Fl oz (120mL), Grape Flavor, NDC #50580-296-04.
Recall # Recall D-097-3.
CODE
a) Lot #EFM041 exp 7/04;
b) Lot #EFM040 exp 7/04.
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA, by letter
on November 20, 2002. Firm initiated recall is ongoing.
REASON
Defective container; product packaged with incorrect dosing cups marked with
metric measurements rather than with U.S. standard measurements
VOLUME OF PRODUCT IN COMMERCE
116172 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0302-3;
b) Fresh Frozen Plasma, Recall # B-0303-3.
CODE
a) and b) Unit number 5444947.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated March 21, 2002. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical
history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_____________________________
PRODUCT
Human Tissue for Transplantation, Corneas.
Recall # B-0304-3.
CODE
Numbers 02-0954-100 and 02-0954-200.
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO, by letter on October 31, 2002. Firm
initiated recall is complete.
REASON
Human tissue for transplantation was incorrectly tested for viral markers in
that the blood sample used for testing was likely hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
FL and Saudi Arabia.
_____________________________
PRODUCT
Red Blood Cells, Recall # B-0310-3.
CODE
Units 0372386, 8726578.
RECALLING FIRM/MANUFACTURER
Florida Blood Services Inc., St. Petersburg, FL, by fax on August 20, 2002.
Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Pool Platelets that were implicated
in a transfusion fatality, and found to be contaminated with Staphylococcus
epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0312-3.
CODE
Unit 107252493.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated August 29, 2002. Firm initiated
recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0313-3.
CODE
Unit 362637279.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Ventura, CA, by telephone on January 17, 2002. Firm initiated
recall is complete.
REASON
Blood product that were out of controlled storage for more than 30 minutes were
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0334-3.
CODE
Unit GR16766.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone
on February 25, 2002 and by letter dated February 28, 2002. Firm initiated recall
is complete.
REASON
Blood product, collected from a donor who reported living in an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.
_____________________________
PRODUCT
a) Red Blood Cells, Recall # B-0335-3;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0336-3;
c) Platelets, Recall # B-0337-3;
d) Platelets, Pheresis, Leukocytes Reduced,
Recall # B-0338-3.
CODE
a) Unit GR12072;
b) Units T82950, FW26155;
c) Unit T82950;
d) Units FW27489, FW28839, FW30438, FW33069, FW35112.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, WI, by telephone on April
19 and June 7 and 10, 2002 and by letters dated April 11 and June 11, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
WI.
_____________________________
PRODUCT
Platelets, Pooled, Irradiated, Recall # B-0339-3.
CODE
Unit FS02754 - pooled Platelet ID number - P16417.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone
on May 24, 2002 and by letter dated May 29, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0340-3;
b) Platelets, Pooled, Recall # B-0341-3.
CODE
Units GR30167, LE48596;
Unit GR30167 - pooled Platelet ID # - P21990.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone
on June 17, 2002 and by letter dated July 2, 2002. Firm initiated recall is
complete.
REASON
Blood products, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
WI.
_____________________________
PRODUCT
Platelet, Pheresis, Leukoreduced, Recall # B-0359-3;
Platelet, Pheresis, Leukoreduced, Irradiated, Recall # B-0360-3.
CODE
(Split unit),Unit 01LZ27665.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY,
by fax dated March 4, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly labeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0299-3.
CODE
Units 107357155, 107357157, 107357158, 107357160, 107357161.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on August 16, 2002. Firm initiated
recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minute were
distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
AZ.
_____________________________
PRODUCT
a) Whole Blood, Recall # B-0305-3;
b) Red Blood Cells, Recall # B-0306-3;
c) Red Blood Cells, Leukocytes Reduced, Recall # B-0307-3;
d) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0308-3;
e) Recovered Plasma, Recall # B-0309-3.
CODE
a) Unit number 012LR12973;
b) Unit number 012LR12971;
c) Unit numbers 012LJ45951 and 012LJ45968;
d) Unit numbers 012W63899, 012W63898, 012W63897, 012W63907,
012W63896, and 012W63895; the following units were
distributed as two split units: 012W63894, 012W63893,
012W63901, 012W63900, 012W63906, 012W63905, 012W63904,
012W63903, 012W63902, 012W63908, 012KJ90766, and
012W63878;
e) Unit numbers 012LJ45958 and 012LJ45951.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone
and fax on April 17, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for human immunodeficiency virus (HIV) p24
antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
36 units.
DISTRIBUTION
SC, NC, CA and TN.
_____________________________
PRODUCT
Detection Reagent 1 of Digene's Hybrid Capture(TM) System Human Papilloma Virus
DNA Assay test kit, catalog #4401-1030. Recall # Z-0330-3.
CODE
Lot 1601, EXP 2003-05-20
Lot 1733, EXP 2003-05-31.
RECALLING FIRM/MANUFACTURER
Digene Corp., Gaithersburg, MD, by telephone and fax beginning October 8, 2002.
Firm initiated recall is ongoing.
REASON
IVD test kit reagent may give false negative results.
VOLUME OF PRODUCT IN COMMERCE
217 kits.
DISTRIBUTION
Internationally.
_____________________________
PRODUCT
Stryker Wedge turning frame stretcher, model 965.
Recall # B-0331-3.
CODE
All units manufactured from 11/01/01 through 10/15/02. Serial numbers:
0205044264, 0207045797, 0111036590, 0202043279, 0202043280, 0208043250, 0206045817,
0206045818, 0206045819, 0204045104, 0204045393, 0204045394, 0111036727, 0111036728,
0204045278, 0204045276, 0204045277, 0204045315, 0204045177, 0207045798, 01110036522,
0111036523, 011203618, 020142290, 0205044263, 0203043636, 0111036534, 0111036535
and 0208043371.
RECALLING FIRM/MANUFACTURER
Stryker Corp., Kalamazoo, MI, by letter on October 23, 2002. Firm initiated
recall is ongoing.
REASON
Weld failure-anterior and posterior frame may dislodge from stretcher litter.
VOLUME OF PRODUCT IN COMMERCE
29.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Little Soothers Cold pack. Each boxed set (unit) contains 3 patches. The Little
Soother is a 3-inch by 2-inch sealed plastic liquid-filled patch. It was manufactured
in three shapes: a yellow fish, a pink butterfly, and a blue penguin. Recall
# Z-0332-3.
CODE
The product is uncoded and is featured in campaigns 16-18 Wellness Magalog.
Day lot codes: July 8, 9 and 10, 2002 (dates of manufacture)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Avon Products, Inc., New York, NY, by voice message on July
25, 2002 and by letter on July 29, 2002.
Manufacturer: Joy House, China. Firm initiated recall is ongoing.
REASON
Microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
1609 units, each containing three Little Soothers.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Cryolife Valve Allograft. Recall # Z-0333-3.
CODE
Model Number: PV00, Device Serial Number: 6570135.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on/about October 4, 2002. Firm initiated
recall is ongoing.
REASON
Donor tissue had possible sepsis secondary to pyogenic brain abscess.
VOLUME OF PRODUCT IN COMMERCE
One individual heart valve allograft.
DISTRIBUTION
IN.
_____________________________
PRODUCT
HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis
Systems; Made in U.S.A.; Recall # Z-0334-3/Z-0339-3.
The following models are affected:
a) Baxter HomeChoice Automated PD System, catalog 5C4471,
115 volt;
b) Baxter HomeChoice Automated PD System, catalog 5C4474,
220 volt;
c) Yume Automated PD System, catalog T5C4441, 100 volt;
d) Baxter HomeChoice PRO Automated PD System, catalog
5C8310, 115 volt;
e) Baxter HomeChoice PRO Automated PD System,
catalog 5C8320, 220 volt;
f) Yume Plus Automated PD System, catalog T5C8300,
100 volt.
CODE
All HomeChoice and HomeChoice PRO Systems with software versions 8.51 and 8.52.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September
19 and 20, 2002.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall
is ongoing.
REASON
Possible overfill.
VOLUME OF PRODUCT IN COMMERCE
12,667 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Phenylbutazone B.P. 1993, USP XXIII, Bulk Active Pharmaceutical Ingredient,
Made in China, packaged in 25 kg brown fiberboard drums. Recall # V-010-3.
CODE
Lots 9811004, 9811005, 9811006, 9811007, 9812013 (9912013), 9812014 (9912014),
9812015 (9912015), 9901006, 9901007, 9901008, 9902001, 9902002, 9902003, 9903003,
9903006, 9903007, and 9903008. Note: lots listed in parentheses are the new
lot numbers given to the original lot preceding it in the list.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kaltron-Pettibone, Inc., Bensenville, IL, by letters dated September
19, 2002.
Manufacturer: Shanghai Medicinal Corporation No. 15 Pharmaceutical Factory Shanghai,
China. Firm initiated recall is ongoing.
REASON
Expiration dates extended and lot numbers changed.
VOLUME OF PRODUCT IN COMMERCE
354 drums.
DISTRIBUTION
MO, NY and OH.
_____________________________
PRODUCT
1A5E Purina CS Cornerstone Complete 18% DQ 0.0066%-MTH 4 (a
medicated feed for heifers containing 0.0066% Decoquinate and 4 g/ton of Methoprene).
Recall # V-009-3.
CODE
101525059.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Purina Mills, LLC., St. Louis, MO, by telephone on October 2,
2002.
Manufacturer: Purina Mill, LLC., Nashville, TN. Firm initiated recall is complete.
REASON
Feed mix-up, medicated feed was delivered in place of non- medicated feed.
VOLUME OF PRODUCT IN COMMERCE
5,023 pounds.
DISTRIBUTION
TN.
END OF ENFORCEMENT REPORT FOR DECEMBER 25, 2002
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