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U.S. Department of Health and Human Services

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Enforcement Report for February 25, 2004

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.


February 25, 2004
04-08

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
a) Pasta Florentine sold in 4.5 lb containers. The product
is shipped in cases that contain 2 containers. Recall #
F-122-4;
b) Pasta and Vegetables sold in 5 lb containers. The
product is shipped in cases that contain 2 containers.
c) Recall # F-123-4;
Shells in water sold in 4 lb containers. The product is
shipped in cases that contain 2 containers. Recall #
F-124-4;
d) Bowties in water sold in 4 lb containers. The product is
shipped in cases that contain 2 containers. Recall #
F-125-4;
CODE
a) Date codes: 12/16/332, 12/19/335, 12/21/337, 12/22/338,
12/26/342, 12/27/343, 12/28/344, and 12/29/345;
b) Date codes: 12/16/329, 12/24/337, and 1/2/346;
c) and d) Product has an 18 day use by date on the product;
however actual dates/codes were not available;
RECALLING FIRM/MANUFACTURER
Isabelle's Kitchen, Inc., Harleysville, PA, by letters on December 15 and 16, 2003. FDA initiated recall is complete.
REASON
Products contain undeclared egg whites.
VOLUME OF PRODUCT IN COMMERCE
5,530 lbs.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Betty Crocker brand Triple Chunk Supreme Brownie Mix, Net.
Wt. 1 lb. 5.2 oz. (21.2 oz.). Recall # F-126-4.
CODE
"Better If Used By" 29OCT04CF.
RECALLING FIRM/MANUFACTURER
General Mills, Golden Valley, MN, by letter on December 19, 2003. Firm initiated recall is complete.
REASON
Product contains undeclared pecans - some packages labeled as Triple Chunk Supreme Brownie Mix actually contained a different product, Turtle Supreme Brownie Mix.
VOLUME OF PRODUCT IN COMMERCE
9,796 cases/each w/12/21.2 oz. boxes.
DISTRIBUTION
The product was distributed nationwide in the United States with the exception that there was no distribution west of the Rocky Mountains or to the Mountain States.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Desmopressin Acetate Injection, (desmopressin acetate
4 mcg. and sodium chloride 9 mg) 4 mcg/mL, 1 mL UNI-AMP
unit dose pak ampuls, 10 ampuls per box, Rx Only, For I.V.
or Subcutaneous Use Only. Recall # D-110-4.
CODE
Lot Number 014203A, Expiration Date: February 1, 2005.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated January 16, 2004. FDA initiated recall is ongoing.
REASON
Unapproved New Drug: Manufacturing change did not have an ANDA preapproval.
VOLUME OF PRODUCT IN COMMERCE
18,740 ampuls.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0711-4.
CODE
Unit number 3853788.
RECALLING FIRM/MANUFACTURER
Department of the Army, Walter Reed Army Medical Center Blood Bank, Washington, D.C., by facsimile on August 28, 2003. 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
NJ.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0712-4.
CODE
Unit number 12798-8583.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on December 11, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is ongoing.
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
NM.

_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced. Recall # B-0655-4;
b) Fresh Frozen Plasma. Recall # B-0656-4.
CODE
a) and b) Unit 16LQ29428.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by letter dated October 23, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH and CA.

_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced. Recall # B-0717-4;
b) Fresh Frozen Plasma. Recall # B-0718-4.
CODE
a) and b) Unit 42Y36933.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by telephone on October 22, 2003 and letter dated October 23, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0719-4;
b) Plasma, Cryoprecipitate Reduced. Recall # B-0720-4.
CODE
a) and b) Unit 40FE77901.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Heart of America Region, Peoria, IL, by telephone on October 20, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0721-4.
CODE
Units G55267093, G54808093, G54098093, G53859093, G53196093, G52942093, G50387093, G50047093, G42106093, G41955093, G40956093, G40796093, G40403093, G40217093, G39814093, G31834093, G32460093, G32275093, G30291093, G30036093, and G29763093.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Brownsville, TX, by facsimile on February 25 and 26, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
United Kingdom and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-0722-4.
CODE
Units T46092093, T46242093, T46419093, T46577093, T46775093, T46964093, T47148093, T47318093, T47446093, T47670093, T47742093, T47917093, T47998093, T48174093, T48265093, T48924093, T48956093, T50699093, and T50762093.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Brownsville, TX, by facsimile on November 4, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0723-4.
CODE
Unit number 04FS58223.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by facsimile on November 12, 2003. 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
MA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0724-4.
CODE
Unit numbers G22802 and G24297.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Bank, Springfield, IL, by facsimile on September 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0725-4.
CODE
Unit number F74670.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Bank, Springfield, IL, by facsimile on September 19, 2003. 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
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0726-4.
CODE
Unit number 3504479.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on April 9, 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
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0727-4;
b) Fresh Frozen Plasma. Recall # B-0728-4.
CODE
a) and b) Unit FH30932.
RECALLING FIRM/MANUFACTURER
Inova Health System, Blood Donor Services, Annandale, VA, by letter dated November 19, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who tested negative for anti-HIV-1/2, but previously tested positive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0730-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0731-4;
c) Fresh Frozen Plasma. Recall # B-0732-4;
d) Recovered Plasma. Recall # B-0733-4.
CODE
a) Unit FE85050;
b) Units FH28172, FE81745;
c) Unit FE81745;
d) Units FH28172, FE85050.
RECALLING FIRM/MANUFACTURER
Inova Health System, Blood Donor Services, Annandale, VA, by letter dated November 19, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who provided post donation information regarding having previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0734-4.
CODE
Unit number 3506042.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on April 1, 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
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0735-4.
CODE
Unit number 2109714.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on December 12, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0736-4;
b) Cryoprecipitated AHF. Recall # B-0737-4;
c) Recovered Plasma. Recall # B-0738-4.
CODE
a), b), and c) Unit number 3634274.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on December 12, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA and Germany.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0739-4.
CODE
Unit number 18GG61710.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on November 10, 2003. Firm initiated recall is complete.
REASON
Blood product, that was found to be out of specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0740-4;
b) Recovered Plasma. Recall # B-0741-4.
CODE
a) and b) Unit number 18FK71587.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by facsimile and electronic mail on October 20, 2003, and by letter on October 21, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI. and CA.

_______________________________
PRODUCT
Platelets. Recall # B-0742-4.
CODE
Unit numbers 18FT62086, 18GN18637, and 18FQ18530.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by letter on April 8, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0743-4;
b) Cryoprecipitated AHF. Recall # B-0744-4;
c) Recovered Plasma. Recall # B-0745-4.
CODE
a), b), and c) Unit number 18GM02228.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone, facsimile, electronic mail, and letter on September 25 and 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0746-4.
b) Platelets, Leukocytes Reduced. Recall # B-0747-4.
CODE
a) and b) Unit number 0946038.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter on June 6, 2003, and facsimile on January 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0748-4;
b) Platelets. Recall # B-0749-4.
CODE
a) and b) Unit number 6803864.
RECALLING FIRM/MANUFACTURER
Lifeshare, Inc., Elyria, OH, by letter dated December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0763-4.
CODE
Units 2533815 and 3628762.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated February 11, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0764-4.
CODE
Unit 3629969.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated February 24, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0765-4;
b) Recovered Plasma. Recall # B-0766-4.
CODE
a) and b) Unit 3408521.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated April 2, 2003, and by facsimile on April 4, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at increased risk for new variant Creuztfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA. and Austria.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0767-4;
b) Recovered Plasma. Recall # B-0768-4.
CODE
a) and b) Unit 3301589.
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile or letter dated July 31, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was born or emigrated from an area with increased risk of human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0751-4.
CODE
Unit 0945492.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by telephone on May 7, 2003. Firm initiated recall is complete.
REASON
Blood product, which tested repeatedly reactive for the antibody to the hepatitis C virus encoded antigen (anti-HCV) but was negative by confirmatory testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0761-4.
CODE
Unit 1030501.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by telephone on August 7, 2003. Firm initiated recall is complete.
REASON
Blood product, which tested positive for the E antigen, but was incorrectly labeled as E antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00. Recall # Z-0538-04.
CODE
CPU Serial Numbers: LT00001-LT000015, LT000017-LT000019, TA00274, TA00415, TA00415-HA, TA00468, TA00554, TA00582, TA 00587, TA00587-HA, TA00639, TA00738, TA00745, TA00854, TA00856, TA00861, TA00880, TA00889, TA00891, TA01200, TA01217, TA01218, TA01253, TA01278, TA01279, TA01286, TA01304, TA01306, TA01327, TA01359, TA01359-HA, TA01387, TA01387-HA, TA01388-TA01398, TA01391HA, TA01400-TA01411, TA01413-TA01423, TA01426-TA01435, TA01433-HA, TA01438--TA01446, TA01448-TA01455, TA01453-HA, TA01457-TA01461, TA01463, TA01463-HA, TA01464, TA01466-TA01469, TA01471-TA01480, TA01473-HA, TA01478-HA, TA01481-HA, TA01482-TA01486, TA01484-HA, TA01485-HA, TA01488, TA01488-HA, TA01490-TA01493, TA01493-HA, TA01499-TA01515, TA01508-HA, TA01509-HA, TA01510-HA, TA01515-HA, TA01517-TA01526, TA01522-HA, TA01523-HA, TA01525-TA01528, TA01530-TA01546, TA01534-HA, TA01535-HA, TA01536-HA, TA01537-HA, TA01544-HA, TA01548-TA01550, TA01552--TA01561, TA01561-HA, TA01563-TA01570, TA01567-HA, TA01568-HA, TA01574.
RECALLING FIRM/MANUFACTURER
Welch Allyn Protocol, Inc., Beaverton, OR, by letter dated December 31, 2003. Firm initiated recall is ongoing.
REASON
Potential failure to audibly alarm due to speaker hardware component failure.
VOLUME OF PRODUCT IN COMMERCE
233 devices.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF. Recall # Z-0539-04.
CODE
No Codes.
RECALLING FIRM/MANUFACTURER
Staar Surgical Co., Inc., Monrovia, CA, by letters on February 9, 2004. FDA initiated recall is ongoing.
REASON
Risk of hyperopic refractive changes.
VOLUME OF PRODUCT IN COMMERCE
160,642.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR FEBRUARY 25, 2004

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