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.

January 7, 1998 98-01

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============

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PRODUCT Good Sense Snacks brand Yogurt Flavored
Raisins, 16 ounces (454 g).
Recall #F-184-8.
CODE "Freshest if used by" "020799" and "020899"
are on 16 ounce retail packages of the
recalled product. A shift number (1 or 2) is
below the "Freshest if used by" date.
"11-07-97" and "11-08-97" are on the recalled
product cases.
MANUFACTURER Waymouth Farms, Inc., New Hope, Minnesota.
RECALLED BY Manufacturer, by telephone on December 10,
1997, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 488 cases (12 packages per case) were
distributed.
REASON Undeclared peanuts. Some packages contain
yogurt covered peanuts.

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PRODUCT Cool-A-Coo Ice Cream products:
a) In the Chips Ice Cream Sandwiches, 5 ounces
b) Chocolate Ice Cream Cup, 3 ounces.
Recall #F-215/216-8.
CODE a) "JUL 10 98" and "AUG 07 98"
b) "JUL 10 98".
MANUFACTURER Cool-A-Coo Ice Cream Company, Inc., Whittier, California.
RECALLED BY Manufacturer, by letter after August 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY a) 748 cases; b) 1,370 cases were distributed.
REASON Products may be contaminated with Listeria
monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
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PRODUCT Variegates, sold in bulk containers and used
in the production of ice cream:
a) Chocolate Flavor Variegate, PRODUCT #201
b) Chocolate Flavor Variegate, PRODUCT #203
c) Chocolate Flavor, PRODUCT #205
d) Chocolate Flavor Variegate, PRODUCT #205T
e) Chocolate Flavor Variegate, PRODUCT #207P
f) Marshmallow Variegate, PRODUCT #224B.
Recall #F-171/176-8.
CODE Lot numbers: a) 01299755; b) 11139629
c) 10259652; d) 03129720, 07169637, 07239662,
08219646, 08219647, 10299657, 10299658,
11079615, 11079616; e) 10029608, 02119723
f) 10219641.
MANUFACTURER Nog, Inc., Dunkirk, New York.
RECALLED BY Manufacturer, by letter dated August 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION New York, Pennsylvania, Vermont, North
Carolina, Ohio.
QUANTITY Undetermined.
REASON The firm failed to comply with GMP's covering
the manufacture of low-acid canned foods.

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PRODUCT Reese brand Flat Fillets of Anchovies packed
in pure olive oil with added salt in metal
cans, Net Wt. 2 oz., 100 tins per case.
Recall #F-177-8.
CODE Can code SN229R stamped on the lid - UPC Code
70670-00666
MANUFACTURER Sonial, Societe du Nord Pour L'Industrie
Alimentaire, Oudja, Morocco.
RECALLED BY World Finer Foods, Inc., Bloomfield, New
Jersey, by telephone on September 25, 1997,
and October 3, 1997, followed by letters dated
September 25, 1997, and October 7, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 1,050 cases were imported.
REASON Product contains histamine.

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PRODUCT Golden Sun brand Duck Sauce, in 30 ounce jars.
Recall #F-178-8.
CODE All containing undeclared sulfites.
MANUFACTURER Viscusi Wholesale Grocers, Inc.,
Schenectady, New York.
RECALLED BY Manufacturer, by memorandum dated December 15,
1997. Ongoing recall resulted from sample
analysis and followup by the New York State
Department of Agriculture and Markets.
DISTRIBUTION New York, New Jersey, Connecticut, Vermont.
QUANTITY Approximately 1,901 cases.
REASON Product contains undeclared sulfites.

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PRODUCT Golden Lion brand Roasted Melon Seed (Red), in
12 ounce plastic bags. Recall #F-183-8.
CODE None. All product containing the unapproved
color additive Ponceau 4R is under recall.
MANUFACTURER Hua Feng Food Co. Ltd. Taishan City, China.
RECALLED BY Blooming Import Inc., Brooklyn, New York,
by letter dated June 2, 1997. Completed recall
resulted from sample analysis and followup by
the New York State Department of Agriculture
and Markets.
DISTRIBUTION New York.
QUANTITY 29 cartons (50 bags per carton) were
distributed.
REASON The product contains the unapproved color
additive Ponceau 4R.

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UPDATE Recall #F-202/210-8, Windmill Farms brand
bakery products, which appeared in the
December 24, 1997 Enforcement are completed
recalls but the followup and analysis was done
by NYK-DO and FDA's Northeast Regional
Laboratory (NRL).

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
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PRODUCT Sara Lee frozen cakes and muffins in food
service packaging:
a) Sara Lee Food Service Bakery Elegant
Expressions Chocolate Chocolate Torte, Net Wt.
56 oz., 2 tortes per case, SKU 8748, UPC
32100-08748
b) Sara Lee Two-Mendous Treats Carrot Cake and
Cinnamon Swirl Cheesecake, Net Wt. 5 lb. 5
oz., 2 cakes per case, SKU 8120, UPC
32100-08120
c) Sara Lee Food Service Bakery Low Fat 2-1/8
oz. Banana Nut Muffins, 24 muffins per tray, 4
trays per case, Net Wt. 12 lb. 12 oz., SKU
8689, UPC 32100-08689
d) Sara Lee Food Service Bakery 2-1/8 oz.
Banana Nut Muffins, 24 muffins per tray, 4
trays per case, Net Wt. 12 lb. 12 oz., SKU
8677, UPC 32100-08677. Recall #F-179/182-8.
CODE a) lots 14017316XX, 14017317XX, 14017318XX,
14017319XX, 14017322XX, 14017323XX,
14017324XX, 14017325XX
b) lot 14017319XX; c) lot 04047325XX
d) lot 04047318XX. Please note for the
specific codes, the XX is the hour 00
through 24.
MANUFACTURER Simon Brothers Bakery Inc., Skokie, Illinois
(products a & b)
Sara Lee Bakery Tarboro, North Carolina.
(products c & d).
RECALLED BY Sara Lee Bakery, Chicago, Illinois, by
telephone on December 4 & 5, 1997, followed by
letter on December 5, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION North Carolina, Illinois, South Carolina,
Maryland, Wisconsin, California, Florida,
Kansas, Ohio, Minnesota, New York, Virginia,
Colorado, District of Columbia, Missouri,
Pennsylvania, Michigan, Nevada.
QUANTITY 1,370 cases were distributed; firm estimated
that 50 percent of product remained on market
at time of recall initiation.
REASON The products may contain small pieces of white
plastic.

RECALLS AND FIELD CORRECTIONS: DRUGS --
CLASS III ==========
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PRODUCT Physicians's Slim and Trim Herbal-Phen AM
Weight Control Capsules (Ma Huang 365, mg/St.
John's Wort 365 mg), 90 capsules (Kit), OTC
dietary s upplement which makes therapeutic
claims. Recall #D-052-8.
CODE Lot numbers: 0917971, 1007972, 1007971.
MANUFACTURER Energy Factors, Inc., Largo, Florida.
RECALLED BY Manufacturer, by telephone on October 28,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY 578 kits were distributed.
REASON Product labeled as containing 365 mg of
each active ingredient while product actually
contains 360 mg of each active ingredient.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
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PRODUCT Red Blood Cells. Recall #B-395-8.
CODE Unit numbers: 09F56046, 09FJ16397, 09GN19482.
MANUFACTURER American Red Cross Blood Services, Omaha,
Nebraska.
RECALLED BY Manufacturer, by telephone on September 24,
1996, and by letter dated October 3, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 3 units were distributed.
REASON Blood products were tested for
Cytomegalovirus
(CMV) not according to the manufacturers'
directions for use.

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PRODUCT a) Cryoprecipitated AHF Pooled
b) Plasma Cryo Supernatant.
Recall #B-400/401-8.
CODE Unit numbers: 17LC00609; b) 17KM09721.
MANUFACTURER American Red Cross, North Central Blood
Services, St. Paul, Minnesota.
RECALLED BY Manufacturer, by telephone on February 26,
1997, followed by letter dated March 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit of each component was distributed.
REASON Unit of Red Blood Cells, implicated in a
transfusion reaction, were found to be
contaminated with Peptostreptoccoccus
tetradis. Corresponding blood products
were distributed.
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PRODUCT a) Red Blood Cells; b) Platelets
c) Fresh Frozen Plasma. Recall #B-402/404-8.
CODE Units Numbers: 574596, 31001261; b) 574596;
c) 31001261.
MANUFACTURER Stewart Regional Blood Center, Inc., Tyler,
Texas.
RECALLED BY Manufacturer, by letter dated September 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but was collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1.

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PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-407/408-8.
CODE Unit numbers: 31KN09813, 31KH17241.
MANUFACTURER American Red Cross Blood Services, Buffalo,
New York.
RECALLED BY Manufacturer, by letter dated June 3,1996,
and by fax dated May 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York and California.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor
with a history of hepatitis.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
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PRODUCT Red Blood Cells, Irradiated.
Recall #B-393-8.
CODE Unit numbers: L81688, S80708, S80713, S80714,
S80719, S80720, S80732, V22220, V22264,
V22504, W44414, W44580.
MANUFACTURER Vector Health Systems, doing business as Rhode
Island Blood Center, Providence, Rhode Island.
RECALLED BY Manufacturer, by telephone on December 4,
1996, and by letter dated December 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Rhode Island.
QUANTITY 12 units were distributed.
REASON Blood products were labeled with an incorrect
expiration date.

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PRODUCT a) Red Blood Cells; b) Platelets, Pheresis.
Recall #B-405/406-8.
CODE Unit numbers: a) 40FX16218, 40FX16221;
b) 40P56184.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone on October 3, 1997,
and by letter dated November 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY a) 2 units; b) 1 unit.
REASON Blood products were stored at unacceptable
temperatures.

END OF ENFORCEMENT REPORT FOR JANUARY 7, 1998. BLANK PAGES MAY FOLLOW.

End of Enforcement Report for