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.

August 4, 1999 99-31

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________
PRODUCT
Crimson Clover Seeds, in 50 pound three ply paper bags.
#Recall #F-578-9.
CODE
Lot W8-8-CC-861.
MANUFACTURER
Van Dyke Seed Company, Forest Grove, Oregon.
RECALLED BY
Dover Sales Company, Inc., Piedmont, Oklahoma, by telephone on
June 4, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Arizona, Colorado, Florida, Hawaii, Illinois, Massachusetts,
Maine, Pennsylvania, Texas, Utah, Washington state, Puerto Rico.
QUANTITY
401 bags were distributed.
REASON
The product may be contaminated with Salmonella Typhimurium.
These seeds were associated with an outbreak of Salmonella
Typhimurium in Colorado.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Wiosenne Candy (chocolate coated jelly fruit candies), packaged
in 13 ounce flexible plastic. Product of Poland. Recall #F-472-9.
CODE
All codes.
MANUFACTURER
Solidarnosc SPPS, Lubrlin, Poland.
RECALLED BY
Slodycze Inc., Brooklyn, New York, by telephone on November 25,
1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.
DISTRIBUTION
New Jersey and Connecticut.
QUANTITY
2 cases (16 packages per case) were distributed.
REASON
The product contains several color additives listed in
terms of the European designation for such colors. These colors
do not conform to the U.S. color additive regulations as follows:
1) E124 - Ponceau 4R - unapproved color additive
2) E104 - Monosulfonated Quinoline Yellow - not approved for use
in food
3) E132 - Indigotine - certifiable as FD&C Blue No. 2, however,
the "E" designation suggests the color has not been certified
4) E110 - Sunset Yellow - certifiable as FD&C Yellow No. 6,
however, the "E" designation suggests the color has not been
certified.
________
PRODUCT
a) Mustard Potato Salad in 10 lb. cartons labeled as "Always
Better Salads" and "Sandridge Gourmet Salads, Medina, Ohio 44256"
b) Health Salad in 10 lb. cartons labeled as "Sandridge
Gourmet Salads" and "Sandridge Food Corporation, Medina, OH 44256"
c) Surfside Pasta in 5 lb. plastic tubs labeled as "Pacific
Cuisine" and "Sandridge Food Corporation, Medina, OH 44256"
d) Macaroni Salad in 10 lb. cartons labeled as "Leon's
Homemade Foods, Medina, OH 44256"
e) Salsa Salad in 5 lb. plastic tubs labeled as "Leon's
Homemade Foods, Medina, OH 44256"
f) Seafood Salad in 5 lb. plastic tubs labeled as "Leon's
Homemade Foods, Medina, OH 44256"
g) Homestyle Celery Stuffing in 8 lb. cartons labeled as
"Gordon Food Service, Grand Rapids, MI 49548"
h) Preservative Free Potato Salad labeled as "Sandridge
Gourmet Salads" and "Sandridge Food Corporation, Medina, OH 44256"
i) Macaroni and Cheddar Salad in 1 lb. plastic tubs, 1.5 lb.
plastic tubs and 10 lb. cartons labeled as "Sandridge Food
Corporation, Medina, OH 44256"
j) Chicken Salad Dressing in 2 lb. plastic pouches labeled
as "Sandridge Gourmet Salads" and "Sandridge Food Corporation,
Medina, OH 44256"
k) Macaroni Salad in 1 lb. plastic tubs labeled as "Original
Amish Recipes" and "Melch's Country Recipes, Medina Ohio 44256".
Recall #F-548/558-9.
CODE
PRODUCT NAME/PKG TYPE SELL-BY-DATE BRAND NAME
a) Mustard Potato Salad, 7/30/99 Sandridge
in 10 LB cartons
b) Health Salad, 7/30/99 Sandridge
in 10 LB cartons
c) Surfside Pasta, 7/10/99 Pacific
in 5 LB plastic tubs
d) Macaroni Salad, 7/10/99 Leon's
in 10 LB cartons
e) Salsa Salad, 7/5/99 Leon's
5 LB plastic tubs
f) Seafood Salad, 7/10/99 Leon's
in 5 LB plastic tub
g) Homestyle Celery Stuffing, 7/15/99 Gordon
in 8 LB cartons
h) Preservative Free Potato Salad, 7/11/99 Sandridge
in 10 LB plastic tubs
i) Macaroni and Cheddar Salad, 7/31/99 Sandridge
in 1 LB and 1.5 LB plastic tubs, and 10 LB cartons
j) Chicken Salad Dressing, 6/29/99 Sandridge
in 2 LB plastic pouches
k) Amish Macaroni Salad, 7/31/99 Amish Recipes
in 1 LB plastic tubs.
MANUFACTURER
Empress Sahara, Mexicali, Mexico (celery grower).
RECALLED BY
Sandridge Food Corporation, Medina, Ohio, by telephone on June 16
and 18, 1999. Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania, Indiana, Ohio, Colorado, Kentucky, Michigan,
Wisconsin.
QUANTITY
7,348 pounds of the various products were distributed.
REASON
The products were manufactured using celery that may be
contaminated with Shigella. The products were not subjected to
processing known to kill the Shigella.
________
PRODUCT
Papaya Chunks and Papaya Spears, Products of Thailand, packaged
in bulk 1 kilo bags. Recall #F-564/565-9.
CODE
a) None; b) Importer Stock #051600 1-100.
MANUFACTURER
Eli Fried, Inc., New York, New York.
RECALLED BY
Manufacturer, by telephone on May 19, 1998. Completed field
correction (relabeling) resulted from sample analysis and follow-
up by the New York State Department of Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
Undetermined.
REASON
Products did not bear an ingredient statement and contained FD&C
Yellow No. 6.
________
PRODUCT
Sahara brand Fresh Celery. Recall #F-566-9.
CODE
None.
MANUFACTURER
Empress Sahara, Mexicali, Mexico (grower).
RECALLED BY
Sahara Packing, Division of Kudu, Inc., Brawley, California, by
telephone on June 16, 1999. Firm-initiated recall complete.
DISTRIBUTION
California, Colorado, Florida, Minnesota, Ohio, Canada.
QUANTITY
558 cartons.
REASON
Product is contaminated with Shigella.
________
PRODUCT
Siebin Strawberry Confectionery Paste, in 1 Kg packages.
Recall #F-568-9.
CODE
All.
MANUFACTURER
C. Siebrecht Sohne GmbH & Company KG, Hanover, Germany.
RECALLED BY
Paris Gourmet of New York, Inc., Carlstadt, New Jersey
(importer), by fax on November 10 and 11, 1998, and by telephone.
Completed recall resulted from sample analysis and follow-up by
the New York State Department of Agriculture and Markets.
DISTRIBUTION
Nationwide.
QUANTITY
26 cases of 6 1-kg. containers were distributed.
REASON
Product contains the unapproved color additive Ponceau 4R.
________
PRODUCT
Iced Tea under the following labels: a) Lemon Flavored Diet
Nestea Iced Tea; b) Pure Nestea Iced Tea.
Recall #F-569/570-9.
CODE
9124NP.
MANUFACTURER
The Minute Maid Company, for Coca-Cola USA, Northampton,
Massachusetts.
RECALLED BY
Coca Cola USA Operations, Atlanta, Georgia, by E-mail and fax on
June 16, 1999. Firm-initiated recall complete.
DISTRIBUTON
Indiana, Maine, Massachusetts, Maryland, New Hampshire, New
Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia,
West Virginia.
QUANTITY
a) 6,568 cases; b) 13,753 cases were distributed.
REASON
Products may contain pieces of glass.
________
PRODUCT
Associated Grocers Carrot Cakes: a) 7" Round Carrot Cake;
b) 8" Square Carrot Cake. Recall #F-571/572-9.
CODE
MAY 28 99.
MANUFACTURER
Signature Bakery, Lynnwood, Washington.
RECALLED BY
Manufacturer, by letters dated May 27, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Washington state, Oregon, Alaska, Guam.
QUANTITY
Undetermined.
REASON
Product contained undeclared FD&C Yellow No. 5 and 6.
_______
UPDATE
CTF brand Pickled Mango and Pickled Lotus Rootlet which appeared
in the July 21, 1999 Enforcement Report should read Recall #F-
546/547-9.
________
PRODUCT
Bee's Queen brand Pure Chinese Honey, packed in 10 ounce glass
jars. Recall #F-563-9.
CODE
None.
MANUFACTURER
Shanghai Native Produce I/E Corporation, Shanghai, China.
RECALLED BY
Yick Cheung Trading Corporation, doing business as Good World
Trading, Brooklyn, New York (distributor), by telephone on August
4, 1998. Completed field correction (relabeling) resulted from
sample analysis and follow-up by the New York State Department of
Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
13 cases (48 jars per case) were distributed.
REASON
Label falsely represented the product as "Pure Honey", since it
contains sugars of cane or corn origin.
________
PRODUCT
a) Seasoning Salt in 32 ounce plastic bottles, under SALMA All
Natural label, and in 14 ounce plastic bottles under Casablanca
label; b) Meat Tenderizer in 32 ounce plastic bottles under the
Selma All Natural label, and in 14 ounce plastic bottles, under
the Casablanca label; c) Cajun Seasoning, in 32 ounce plastic
bottles under the SALMA All Natural label, and in 14 ounce
plastic bottles under the Casablanca label. Recall #F-573/575-9.
CODE
All lots.
MANUFACTURER
Ramm & Brothers, East Elmhurst, New York (packer).
RECALLED BY
Salma, Limited, Maspeth, New York, by visit, followed by letter
dated June 7, 1999. Completed recall resulted from sample
analysis and follow-up by the New York State Department of
Agriculture and Markets.
DISTRIBUTION
New York and New Jersey.
QUANTITY
The firm estimated the total volume of products distributed from
January 1997 through January 1998, were as follows:
a) Salma brand Seasoning Salt, net wt. 32 oz.: 59 cases (12
bottles per case);
Casablanca Spices brand Seasoning Salt, net wt. 14 oz.: 24 cases
(12 bottles per case).
b) Salma brand, Meat Tenderizer, net wt. 32 oz.: 33 cases (12
bottles per case);
Casablanca Spices brand Meat Tenderizer, net wt. 14 oz.: 9 cases
(12 bottles per case).
c) Salma brand Cajun Seasoning, net wt. 32 oz.: 18 cases (12
bottles per case);
Casablanca Spices brand Cajun Seasoning, net wt. 14 oz.: 14 cases
(12 bottles per case).
REASON
Products contained undeclared MSG.
________
PRODUCT
Pecorino Primo Sale Cheese White (Bianco), net weight
approximately 4-5 kilos, mainly labeled in Italian and
French.Recall #F-576-9.
CODE
Expiration dates: 15 12.99 (December 15,1999) and 30 11.99
(November 30, 1999).
MANUFACTURER
Spatafora Formaggi, Italy.
RECALLED BY
Lauria Food Enterprise, Inc., Howard Beach, New York, by letter
dated April 2, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
New York, Pennsylvania, New Jersey.
QUANTITY
25 cartons of 6 4-5 kilo wheels were distributed.
REASON
Product contains E. coli in excess of the action level, which
indicates that the cheese was prepared under insanitary
conditions.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
Atenolol Tablets, USP, 25 mg, in unit dose packages of 100 (10
strips/10 tablets) and Robot Ready Cards (25 cards of 1 tablet),
Rx oral beta-selective beta-adrenergic receptor blocking used in
the management of hypertension and angina pectoris. NDC #51079-
759-20 and NDC #517079-759-19.
Recall #D-290-9.
CODE
Lot Numbers: 9B254, 9A124, 8M577, 8P694.
MANUFACTURER
Lederle Pharmaceutical, Division of American Cyanamid,
Pearl River, New York.
RECALLED BY
UDL Laboratories, Inc., Rockford, Illinois, by letter dated June
25, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
27,394 unit cartons of 100 tablets and 1,582 unit cartons of 25
tablets were distributed; firm estimated that 20 percent of the
products remained on market at time of recall initiation.
REASON
Content uniformity failure.
________
PRODUCT
Compressed Oxygen, USP, in H size cylinders.
Recall #D-292-9.
CODE
Lot #266-0539-64/010-6457.
MANUFACTURER
Air Products & Chemicals, Inc., Guayanilla, Puerto Rico.
RECALLED BY
Manufacturer, by visit July 9-10, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Puerto Rico.
QUANTITY
22 cylinders were distributed.
REASON
Current good manufacturing practice deviation - Lack of records
documenting testing for potency/purity.
________
PRODUCT
Requip® Tablets (Ropinirole HCl), 5 mg, in 100 tablet bottles,
Rx taken orally for the treatment of Parkinson's disease. NDC
#0007-4894-20. Recall #D-293-9.
CODE
Lot Numbers: 680930 EXP 4/30/99, 680940 EXP 7/31/99,
720510 EXP 11/30/99.
MANUFACTURER
SmithKline Beecham Pharmaceuticals, Crawlely, West Sussex.
RECALLED BY
SmithKline Beecham Pharmaceuticals, Philadelphia, Pennsylvania,
by letter sent on March 3, 1999, and June 4, 1999. Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 14,033 bottles remained on market at time of recall
initiation.
REASON
Tablet fading: Pale blue to white.
________
PRODUCT
Yodoxin 650 mg Tablets (lodoquinol USP), in 100 tablet bottles,
Rx anti-amebic. NDC #0516-0093-01.
Recall #D-297-9.
CODE
Lot #49835 EXP 9/2001.
MANUFACTURER
Glenwood, LLC, Piscataway, New Jersey.
RECALLED BY
Manufacturer, by letter on February 22, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
976 bottles were distributed.
REASON
Subpotency (6 month stability).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Protect U-2000 Aerosol, (Pyrethrins Extract 0.30, Piperonyl
Butoxide Technical 3.00, Inert Ingred 96.70), in 5 oz cans, OTC
aerosol used for the control of body lice, head lice, crabs,
nits, and chiggers on human ind inanimate surfaces.
Recall #D-291-9.
CODE
All lot codes.
MANUFACTURER
DiHoMa Chemical and Manufacturing, Inc., Mullins, South Carolina.
RECALLED BY
Manufacturer, by telephone, followed by letter faxed on or about
June 1, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 14,014 cans were distributed; firm estimated that
700-800 cans remained on market at time of recall initiation.
REASON
Product is an unapproved new drug.
________
PRODUCT
Quick Pep® Alertness Aid Tablets, 150 mg caffeine anhydrous, USP,
32 tablet units, OTC indicated as a stimulant.
NDC #11926-006-32. Recall #D-294-9.
CODE
Lot Numbers: SQP196A and SQP796A.
MANUFACTURER
Sidmak Laboratories, E. Hanover, New Jersey.
RECALLED BY
Thompson Medical Company, Inc., Fairfield, New Jersey, by letter
mailed on January 26 and 27, 1999, February 15, 1999, and April
7, 1999. Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
59,940 cartons were distributed.
REASON
Mislabeling - blister card incorrectly declares caffeine
anhydrous, USP, Strength as 200 mg (outer holding carton
correctly labeled as 150 mg).
________
PRODUCT
Procainamide Hydrochloride Extended Release Tablets, Rx products
indicated for use as an anti-arrhythmic:
a) Procanbid(tm) Tablets Extended-Release , 500 mg, in 60 tablet
bottles; b) Procanbid(tm) Tablets, Extended-Release, 1000 mg, in
60 tablet bottles. Recall #D-295/296-9.
CODE
a) Lot #795D6D EXP 10/99, N0071-0562-20
Lot #797D6D EXP 10/99, N0071-0562-20;
b) Lot #33137D EXP 02/00, N0071-0564-20.
MANUFACTURER
Warner-Lambert Company, Morris Plains, New Jersey.
RECALLED BY
The Parke-Davis Division of Warner-Lambert Company, Morris
Plains, New Jersey, a) by letter mailed on April 16, 1999; by
letters mailed on November 11, 1998 and April 30, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 44,098 bottles; b) 10,592 bottles were distributed; firm
estimated that minimal amount of product remained on market at
time of recall initiation.
REASON
Dissolution failure.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
Marquette Clinical Information Center Software. The Clinical
Information Center displays data from up to 16 patient monitors.
Recall #Z-917-9.
CODE
Version V1.4 and all previous versions of the software.
MANUFACTURER
Marquette Medical Systems, Inc., Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone and letter sent on April 8, 1999.
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide, Canada, France, Australia, Italy, Sweden.
QUANTITY
368 units were distributed.
REASON
Defective software could result in failure to give warning.
________
PRODUCT
a) Viscoat Viscoelastic Solution, 0.5 ml, Catalog Number 8065-
1839-05 PMA P840064; b) Duovisc Viscoelastic System, 0.5 Ml,
Catalog Number 8065-1831-05.
Recall #Z-1088/1089-9.
CODE
Lot Numbers: a) 57010P and 57443P; b) 57446P.
MANUFACTURER
Alcon Puerto Rico, Inc., Humacao, Puerto Rico.
RECALLED BY
Manufacturer, by letter on June 18, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
36,390 units were distributed.
REASON
Product was distributed without the cannula locking ring.
________
PRODUCT
Lifestyles & Contempo Assorted Colors Lubricated Condoms Model:
Contempo Intensity Assorted Colors Condoms Product Code 4535 &
4560; Lifestyles Assorted Colors Lubricated Product Code
5303/605149. Recall #Z-1049/1050-9.
CODE
Contempo Intensity Assorted Colors Condoms
Lot Number 0805718400 Product Code 4535
Display Racks (Master Lot 0905000102).
Each display rack contains 5 boxes of Contempo
Intensity
Assorted Colors Condoms (Lot Number 0805718400)
Expiration Date 05/2001 Product Code 4560
Lifestyles Assorted Colors Lubricated
Lot Number 0805718500
Lot Number 0805718800
Expiration Date 05/2001 Product Code 5303/605149.
MANUFACTURER
Ansell, Inc., Dothan, Alabama.
RECALLED BY
Manufacturer, by telephone on June 11, 1999, followed by fax.
Firm-initiated recall ongoing.
DISTRIBUTION
California, North Carolina, New York, Pennsylvania, Florida, and
international.
QUANTITY
1,465 gross were distributed.
REASON
Holes were discovered in condoms during a routine monitoring by
the State of North Carolina.
________
PRODUCT
Eclipse LE II Electrocardiograph, Model 92304.
Recall #Z-1097-9.
CODE
Serial Numbers:
10690000007 to 10690000009, 10690000011 to 10690000051,
10690000055 to 10690000131, 10690000144, 10690000153,
10690000154, 10690000157, 10690000158, 10690000166 to
10690000171, 1070000003.
MANUFACTURER
Spacelabs Burdick, Inc., Deerfield, Wisconsin.
RECALLED BY
Manufacturer, by telephone beginning July 1, 1999, followed by
letter dated July 12, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Taiwan.
QUANTITY
133 devices were distributed.
REASON
The ground wire of the device could fail, due to "over-crimping".
________
PRODUCT
Orthogonal Electrophysiology Catheters:
a) Fixed, 6 French (F); b) Deflectable, 7F;
c) Deflectable, 6F; d) Deflectable, 8F;
e) Mansfield Fixed, 6F, Catalogue No. 5211.
Recall #Z-1105/1109-9.
CODE
Catalog numbers: a) OF-6G-005-MS, OF-6F-010-MO,
OF6-3X4F-010-MO, OF6-3X4G-010-MS, OF6-3X4F-005-MS,
OF6-5X2D-010-FO;
b) OD-7D-010-MS, OD7-8X2D-005-FS, OD7-3X4D-010-MS, 1095-24-S, 1097-
184-S;
c) OD6-3X4G-010-MS; d) OD8-8X2-010-FS; e) 5211.
MANUFACTURER
Paragon Healthcare Corporation, Spartanburg, South Carolina
(reprocessor).
RECALLED BY
Manufacturer, by letter on March 10, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Arkansas, Kansas, North Carolina, Oregon, Pennsylvania, Texas.
QUANTITY
72 catheters.
REASON
An electrode may separate from the catheter, while it is being
separated from a patient.
________
PRODUCT
a) Medtronic DBS Lead Kits for Deep Brain Stimulation, Model Nos.
3382, 3387,3387RES, and 3389;
b) Medtronic Customer Engineered Burr Hole Cap and Ring, Model
Nos. 3350SP and 3350SPJ. Recall #Z-1110/1111-9.
CODE
All lots.
MANUFACTURER
Medtronic, Inc., Neurological Division, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letter sent on May 13, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
5,557 lead kits and 110 burr hole caps were distributed.
REASON
There are visible chemical residues on some of the Burr Hole Caps
through which the leads are inserted.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
Surgidyne VariDyne Vacuum Controller and Collection System, Model
350-2id, a portable powered aspiration pump used for closed
wound, surgical sump, nasogastric and other tube drainage.
Recall #Z-948-9.
CODE
Model 350-2id with serial numbers: 81111, 81112, 81113, 81114,
81115, and 81116.
MANUFACTURER
Surgidyne, inc., Plymouth, Minnesota.
RECALLED BY
Manufacturer, by telephone on March 8, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Pennsylvania and Wisconsin.
QUANTITY
6 mislabeled units were distributed.
REASON
The devices had incorrect graphics plate.

END OF ENFORCEMENT REPORT FOR AUGUST 4, 1999. BLANK PAGES MAY
FOLLOW.

####

FDA

Enforcement Report

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III