FDA

Enforcement Report

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.

 September 6, 2000                                         00-36

RECALLS AND FIELD CORRECTIONS: FOODS CLASS II

PRODUCT
Alinosi brand: a) Banana Ice Cream, packaged in quart and 3-gallon cartons; b) French Vanilla Ice Cream packaged in quart and 3-gallon cartons; c) Mint Chocolate Chip Ice Cream, packaged in quart and 3-gallon cartons; d) Orange Pineapple Ice Cream packaged in quart and 3-gallon cartons; e) Peach Ice Cream, packaged in quart and 3-gallon cartons; f) Pistachio Almond Ice Cream, packaged in quart and 3-gallon cartons; g) Strawberry Ice Cream packaged in quart and 3-gallon cartons. Recall #F-792/798-0.

CODE
All products distributed prior to December 1999.

MANFACTURER
Alinosi Ice Cream & Candy Co., Detroit, Michigan.

RECALLED BY
Manufacturer, by visit in October/November 1999. Firm-initiated field correction (relabeling) complete.

DISTRIBUTION
Michigan.

QUANTITY
Undetermined.

REASON
Products contained undeclared FD&C Yellow No. 5.

______
PRODUCT
Zentis brand Diat Konfiture Extra - Erdbeere (Diet Strawberry Spread), in glass jars, net weight 430-grams. Recall #F-799-0.

CODE
None.

MANFACTURER
Franz Zentis GMBH & Company, Germany.

RECALLED BY
East Coast Foods, Inc., Brooklyn, New York, by letter dated February 28, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York, Pennsylvania, New Jersey, California, Florida, Utah, Massachusetts, Connecticut, Canada.

QUANTITY
120 cases (10 jars per case) were distributed.

REASON
Product contained cyclamate, a substance prohibited from direct addition or use as human food (21 CFR 189.135).

________
PRODUCT
Wing Kee Lung brand Soft Candy, packaged in flexible plastic bags, net wt. 10-oz. Recall #F-805-0.

CODE
None.

MANFACTURER
Shenzhen Constructive Equipments & Materials Import & Expirt Corporation, Shenzhen, China.

RECALLED BY
Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter dated August 4, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture.

DISTRIBUTION
New York.

QUANTITY
28 cases (28 bags per case) wee distributed.

REASON
The soft candy contains the unapproved color additives Ponceau 4R and Carmoisine.

________
PRODUCT
Golden Lion brand Ginger Candy, packaged in 110-gram flexible plastic bags. Recall #F-806-0.

CODE
None.

MANFACTURER
Hua Feng Food Co., Ltd., Taishan City, Japan.

RECALLED BY
Blooming Import Co., Inc., Brooklyn, New York (importer), by letter dated February 29, 2000. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agricluture.

DISTRIBUTION
New York.

QUANTITY
Approximately 51 cases were distributed.

REASON
The product: a) contained sodium saccharin which is not permitted for use in this type of product; b) was actually preserved citrus fruit peel labeled as Ginger Candy; c) label declared sodium benzoate as an ingredient but did not provide a statement of the preservative function.

______
UPDATE
Correction to recall number F-202-3, published in the January 27, 1993 Enforcement Report. FDA has recently been advised by Scrava Pty. Ltd, Smithfield N.S.W. Australia that the recalled Pinuli Herbal Tea was packed for, rather than manufactured by, Scrava Pty. Ltd. by Instituto Botanica La Selva, Monte Video, Uruquay

RECALLS AND FIELD CORRECTIONS: FOODS CLASS III

________
PRODUCT
Infant Formulas: Products distributed in the United States: a) Nestle Carnation Good Start, Milk-Based Infant Formula for Babies 0-12 Months, Concentrated Liquid, 13-fl oz; b) Nestle Carnation Follow-Up, Milk-Based Infant Formula for Babies 4 Months & Older, Concentrated Liquid, 13-fl oz; c) Nestle Carnation Alsoy, Soy Infant Formula for Babies 0-12 Months, Concentrated Liquid, 13-fl oz; Products distributed in Canada: d) Nestle Good start/Nestle Bon Depart (in French) Infant Formula Concentrated Liquid, 385-ml; e) Nestle Follow-Up/Nestle Transition (in French) Infant Formula Concentrated Liquid, 385-ml. Recall #F-800/804-0.

CODE
Alsoy Concentrate: 9337EWAC3876 and 9338EWAC3876 Follow-Up Concentrate: 9300EWFC3785, 9301EWFC3785, 9304EWFC3791, 9351EWFC3907, and 9351EWFC3909 Good Start Concentrate: 9291EWGC3749, 9291EWGC3750, 9291EWGC3752, 9291EWGC3753, 9291EWGC3754, 9292EWGC3754, 9292EWGC3755, 9292EWGC3756, 9292EWGC3757, 9292EWGC3758, 9292EWGC3759, 9293EWGC3759, 9298EWGC3777, 9298EWGC3778, 9299EWGC3779, 9299EWGC3780, 9299EWGC3781, 9299EWGC3782, 9300EWGC3782, 9300EWGC3783, 9300EWGC3784, 9316EWGC3827, 9316EWGC3829, 9316EWGC3830, 9317EWGC3830, 9344EWGC3895, 9344EWGC3896, 9345EWGC3896, 9347EWGC3897, 9348EWGC3897, 0007EWGC3010, 0007EWGC3011, 0007EWGC3012, 0008EWGC3012, 0008EWGC3013, 0013EWGC3030, 0013EWGC3031, 0013EWGC3032, and 0042EWGC3114 Lots recalled in Canada:

Good Start Concentrate: 0014EWGC3033, 0014EWGC3034, 0015EWGC3034, 0042EWGC3114, 0042EWGC3115, 0042EWGC3116, 0042EWGC3117, 0042EWGC3118, 0043EWGC3118, 0043EWGC3119, 9317EWGC3832, 9317EWGC3833, 9317EWGC3834, 9318EWGC3834, 9318EWGC3835, 9318EWGC3837, 9348EWGC3898, 9348EWGC3899 and 9348EWGC3900 Follow-Up Concentrate:

0008EWFC3014, 9304EWFC3791, 9304EWFC3792, 9304EWFC3793 and 9348EWFC3902.

MANFACTURER
Nestle USA, Eau Claire, Wisconsin.

RECALLED BY
Nestle USA, Glendale, California, by visit initiating on March 17, 2000. Press release was issued on March 17, 2000. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
Approximately 250,000 cases (12 cans per case) were distributed.

REASON
The product was manufactured under conditions which suggested that the product may have received a process less than commercially sterile.

________
PRODUCT
1) McDonald's PWE Liquid Egg Product (with preservative nisin) 2) a) McDonald's PWE Liquid Egg Product (no nisin); b) Golden Nature Liquid Egg Product (no nisin). Recall #F-807/808-0.

CODE
1) Codes beginning: 1150, 1160, 1170, 1180, 1190, 1220, 1230 and ending with "P1804; 2) a) CODEs beginning: 1080, 1090, 1100, 1110, 1120, 1150 and ending with P1804; b) Codes beginning: "1100, 1170 and ending with "P1804".

MANFACTURER
Sunny Fresh Foods, Inc., Lake Odessa, Michigan.

RECALLED BY
Sunny Fresh Foods, Inc., Monticello, Minnesota, by telephone on May 16, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 110,553 cases were distributed.

REASON
Product is spoiling because it contains Pseudomonas spp.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS II

________
PRODUCT
Cryoprecipitated AHF. Recall #B-847-0.

CODE
Unit Numbers: 30GH51679 and 30GH51671.

MANFACTURER
American Red Cross Blood Services, Ashley, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on July 6, 1999. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania.

QUANTITY
2 units were distributed.

REASON
Blood products corresponded to two units of red blood cells that were implicated in a transfusion reaction.

________
PRODUCT
Source Plasma. Recall #B-897-0.

CODE
Unit Numbers: WXP093MO, WXP563MO, USM411MO, USP122MO, USU176MO, USU456MO.

MANFACTURER
Aventis Bio-Services, Inc. F.K.A. Centeon Bio-Services, Inc., Louisville, Kentucky (Collection Site).

RECALLED BY
Aventis Central Testing Laboratory, Knoxville, Tennessee, by fax on June 10, 1999, and by letter dated June 18, 1999. Firm-initiated recall complete.

DISTRIBUTION
California and France.

QUANTITY
6 units were distributed.

REASON
Blood products were collected from a donor with a history of having tested positive for hepatitis.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1032/1034-0.

CODE
Unit #24KK00833.

MANFACTURER
American Red Cross Blood Services, Louisville, Kentucky.

RECALLED BY
Manufacturer, by fax on May 2, 2000,and by letters dated May 5 and 11, 2000. Firm-initiated recall complete.

DISTRIBUTION
Kentucky and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot indeterminate.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1098/1099-0.

CODE
Unit Numbers: a) V67169, V80035, Y09064; b) V67169, V80035, Y09064.

MANFACTURER
Aurora Area Blood Bank, Aurora, Illinois.

RECALLED BY
Manufacturer, by letters dated May 23 and 24, 2000. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Switzerland.

QUANTITY
3 units of each component were distributed.

REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (HIV-1/2), but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot negative.

________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-1100-0.

CODE
Unit #40FX17257.

MANFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by telephone on May 17, 2000, and by letters dated May 31,2000, and June 3,2000. Firm-initiated recall complete.

DISTRIBUTION
Alabama.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who was previously deferred at another donor center.

________
PRODUCT
Source Plasma. Recall #B-1102-0.

CODE
Unit Numbers: G63407-076, G63719-076, G65542-076, and G66044-076.

MANFACTURER
Alpha Therapeutic Corporation, Fayetteville, North Carolina.

RECALLED BY
Manufacturer, by letter dated February 24, 1999. Firm-initiated recall complete.

DISTRIBUTION
Spain.

QUANTITY
4 units were distributed.

REASON
Blood products, which tested negative for the hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested reactive for HbsAg.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1103/1104-0.

CODE
Unit #53GN36428.

MANFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated February 28, 2000, and on February 29, 2000. Firm-initiated recall complete.

DISTRIBUTION
Maryland and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor taking the drug Lupron.

________
PRODUCT
Platelets, Pheresis. Recall #B-1105-0.

CODE
Unit #53LT65902.

MANFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letters April 18, 2000, and July 14, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Maryland.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
Red Blood Cells. Recall #B-1106-0.

CODE
Unit #7592305.

MANFACTURER
Carter Blood Center, Bedford, Texas.

RECALLED BY
Manufacturer, by letter dated March 29, 2000. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
a) Red Blood Cells; b) Platelets, Irradiated. Recall #B-1110/1111-0.

CODE
Unit #M58361.

MANFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by telephone on May 1, 2000. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor whose suitability was not adequately determined.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Plasma; d) Source Leukocytes. Recall #B-1112/1115-0.

CODE
Unit Numbers: a) 53GN98918, 53T30027; b) 53GN98918; c) 53GN98918, 53T30027; d) 53T30027.

MANFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letters February 15, 2000 and March 22, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Maryland and New Jersey.

QUANTITY
a) 2 units; b) 1 unit; c) 2 units; d) 1 unit was distributed.

REASON
Blood products were collected from a donor with a history of having tested positive for Hepatitis C.

________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Fresh Frozen Plasma; d) Platelets; e) Buffy Coat; f) Recovered Plasma. Recall #B-1116/1121-0.

CODE
Unit Numbers: a) W05988, W00780, KH17935; b) W04347; c) W05988, KH17935; d) W05988, W00780, KH17935; e) W04347; f) W04347, W00780.

MANFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by telephone on April 4, 2000, and by letters dated April 12, 2000, and May 24, 2000. Firm-initiated recall complete.

DISTRIBUTION
Virginia and Switzerland.

QUANTITY
a) 3 units; b) 1 unit; c) 2 units; d) 3 units; e) 1 unit; f) 2 units were distributed.

REASON
Blood products were collected from a donor with a history of having tested positive for Hepatitis C.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-1123/1125-0.

CODE
Unit #KR26924.

MANFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by telephone on December 15, 1998, and by letter dated 12/23/98. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of having tested positive for Hepatitis B.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1127/1128-0.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter and/or fax on March 29, 31, 2000, April 6, 2000, April 12-14, 2000, and May 18, 2000. Firm-initiated recall complete.

DISTRIBUTION
Maryland, Virginia, Pennsylvania, and District of Columbia.

QUANTITY
a) 118 units; b) 13 units were distributed. REASON Blood products were inappropriately collected in 450-ml collection sets.

________
PRODUCT
Platelets, Pheresis. Recall #B-1131-0.

CODE
Unit #9015822.

MANFACTURER
Medic Regional Blood Center, Knoxville, Tennessee.

RECALLED BY
Manufacturer, by telephone on January 22, 1998, and by letter dated January 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Blood product had an unacceptable platelet count.

________
PRODUCT
Platelets/Granulocytes, Irradiated. Recall #B-1133-0.

CODE
Unit #9019145.

MANFACTURER
Medic Regional Blood Center, Knoxville, Tennessee.

RECALLED BY
Manufacturer, by letter dated May 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with extended expiration dates.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Recovered Plasma. Recall #B-848-0.

CODE
Unit Numbers: 30GH51679 and 30GH51671.

MANFACTURER
American Red Cross Blood Services, Ashley, Pennsylvania.

RECALLED BY
Manufacturer, by fax on July 22, 1999. Firm-initiated recall complete.

DISTRIBUTION
Switzerland.

QUANTITY
2 units were distributed.

REASON
Blood products corresponded to two units of Red Blood Cells that were implicated in a transfusion reaction.

________
PRODUCT
Red Blood Cells for Further Manufacture.

Recall #B-1064-0.

CODE
Unit Numbers: 49FJ69617 and 49FJ72878.

MANFACTURER
American Red Cross Blood Services, Wichita, Falls, Texas.

RECALLED BY
American Red Cross Blood Services, Tulsa, Oklahoma, by letters September 10, 1999, and October 13, 1999. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Michigan.

REASON
Blood products were collected from a donor who lived in an area designated as endemic for malaria.

________
PRODUCT
a) Platelets; b) Fresh Frozen Plasma. Recall #B-1107/1108-0.

CODE
Unit #7733842.

MANFACTURER
Carter Blood Center, Bedford, Texas.

RECALLED BY
Manufacturer, by letter dated April 3, 2000. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood products were prepared from a whole blood unit that had discrepant start and end times documented.

________
PRODUCT
Cryoprecipitated AHF. Recall #B-1109-0.

CODE
Unit #7710990.

MANFACTURER
Carter Blood Center, Bedford, Texas.

RECALLED BY
Manufacturer, by telephone on February 3, 2000. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

________
PRODUCT
Red Blood Cells. Recall #B-1129-0.

CODE Unit #T03926.

MANFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by telephone on April 19, 2000. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with a history of colitis, was distributed.

________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-1130-0.

CODE
Unit Numbers: 49LG48792, 49LG48794, 49LG48795, 49LG48796, 49LG48797, 49LG48798, 49LG48799, 49LG48801, 49LG48802, 49LG48803, 49LG48804, 49LG48805, 49LG48806, 49LG48807, 49LG48809, 49LG48810, 49LG48830, 49LG48831, 49LG48832, 49LG48833, 49LG48834, 49LG48837, 49LG48838, 49LG48839, 49LG48841, 49LG48843, 49LG48845, 49LG48847, 49LG48849, 49LG48852.

MANFACTURER
American Red Cross Blood Services, Waco, Texas.

RECALLED BY
Manufacturer, by letter dated April 20, 2000. Firm-initiated recall complete.

DISTRIBUTED
Texas.

QUANTITY
30 units were distributed.

REASON
Blood products were leukoreduced by filtration greater than five days past the time of collection.

________
PRODUCT
Red Blood Cells, Irradiated. Recall #B-1132-0.

CODE
Unit Numbers: 9004483 and 9004485.

MANFACTURER
Medic Regional Blood Center, Knoxville, Tennessee.

RECALLED BY
Manufacturer, by telephone on May 20, 1997, followed by letter dated June 6, 1997. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
2 units were distributed.

REASON
Blood products were labeled with extended expiration dates.

END OF ENFORCEMENT REPORT FOR Sept. 6, 2000.

####

FDA News Page | FDA Home Page

Office of Public Affairs
Web page uploaded by clb 2000-SEP-05.