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.

April 7, 1999                                             99-14

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
Velvet brand Chocolate Ice Cream, packed in 1 pint size paper cartons. Recall #F-299-9.

CODE
Lot #0119.

MANUFACTURER
Velvet Ice Cream Company, Inc., Utica, Ohio.

RECALLED BY
Manufacturer, by letter on February 22, 1999, and by press release issued by the Ohio Department of Agriculture on February 19, 1999. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
244 gallons (1,952 1-pint containers) were distributed.

REASON
Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT
Mango Tropitango, a dried fruit product, in 1 ounce, 6 ounce and 32 ounce plastic bags. Recall #F-289-9.

CODE

Product Item #288 Lot Codes 1 oz.:
8150  8110  8111  8112  8118  8120  8124  8127
8122  8142  8147  8148  8152  8154  8156  8113
8114  8115  8117  8119  8121  8126  8128  8146
8260  8149  8153  8155  8157
Product tem #288 6 oz:
8096  8098  8105  8147  8182  8194  8196  8209
8222  8247  8258  8264  8285  8287  8097  8104
8127  8166  8183  8195  8208  8220  8243  8251
8259  8280  8286  8317  8318
Product Item #288 32 oz.
8097  8117  8124  8139  8170  8191  8195  8204
8217  8219  8229  8232  8245  8287  8320  8114
8121  8138  8169  8190  8194  8203  8205  8218
8227  8230  8233  8260  8288.

MANUFACTURER
Mariani Packing Company, Inc., San Jose, California.

RECALLED BY
Manufacturer, by telephone and letter November 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Undetermined.

QUANTITY
96,101 cases or 1,379,714 pounds were distributed.

REASON
Product contains undeclared FD&C Yellow NO. 5 and FD&C Yellow No. 8.

________
PRODUCT
Sysco Imperial Scandanavian Blend with--carrots, peas, zucchini, green beans, onions, packed in 6/4 lb. and 1/20 lb. poly bags/case. Recall #F-319-9.

CODE

Date Codes:  8320LC4 and 8363LC1
6/4 lb.  SYSCO ITEM #: 1025980.
1/20 lb.  SYSCO ITEM #:1333228.

MANUFACTURER
Superior Packing and Blending, San Antonio, Texas.

RECALLED BY
Superior Foods, Watsonville, California, by letter on January 19, 1999. Firm-initiated recall complete.

DISTRIBUTION
Arkansas, Florida, Texas, Wisconsin.

QUANTITY
Firm estimates none remains on the market.

REASON
The carrot component of the Product contained elevated levels of lead.

________
PRODUCT
Sun Chips brand Multigrain Snacks, in 14 1/2 ounce packages size containers. Recall #F-320-9.

CODE
Pull Date Code May 04; Manufacturing Code 229104.

MANUFACTURER
Frito-Lay, Inc., Irving, Texas.

RECALLED BY
Frito-Lay, Inc., Plano, Texas, by hand held computer message March 23, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Colorado, Wyoming, Nebraska, South Dakota, Utah.

QUANTITY
900 bags were distributed.

REASON
Product contains undeclared dairy products.

________
PRODUCT

Breads and Cheeses:
a) "White Rice Yeast-Free Loaf For use in Wheat-Free
Gluten-Free Diets", 20.75 oz. vacuum packages in clear plastic
with insert color label, 6 pkgs/case
b) "Potato Loaf For use in Wheat-Free & Gluten-Free Diets",
24 oz. & 4.1 oz., vacuum packaging.  The 24 oz. loaf is clear
plastic with color insert label, the 4.1 oz. contains 2 slices
and the package has black and white adhesive label on outside of
package
c) Pizza shells (2 sizes): "PIZZAS 10 inch Diameter", 33.6
oz. 5 pkgs/case; and "GLUTEN-FREE PIZZAS 6 Inch Diameter", 14.5
oz. 5 pkgs/case.  Both have exactly the same ingredients and are
vacuum packaged in clear plastic.  Pizzas are sandwiched between
cookie sheet paper and then cardboard cake circles.  Adhesive
black and white label is on the outside of the package
d) "Wheat-free Pizza Shells", 22.4 oz., two pizza crusts
vacuum packaged inside a color, retail style carton for retail
sale.  5 pkgs/case
e) "POUND CAKE", 11 oz., vacuum packaged in clear plastic with
color insert label, 6 pkgs/case
f) "English Muffins For use in Wheat-Free & Gluten-Free Diets", 14 oz.
vacuum packaged in clear plastic with insert label, 6 pkgs/case.
g) "Wylde Loaf" 24 oz. vacuum packaged in clear plastic with insert
label, 6 pkgs/case; and 4.5 oz. vacuum packaged in 2 slice package
with black and white adhesive label on outside of package, 14 pkgs/case.
h) "Gluten Free Low Protein Waffles", 7 oz., 2 waffles/vacuum package.
Label affixed to outside of package, 8 pkgs/case.
i) "Cheddar Cheese For use in Low Protein and PKU Diets", 32 oz., vacuum
packaged in clear plastic with color insert label, 6 pkgs/case.
j) "Mozzarella Cheese For use in Low Protein and PKU Diets", 32 oz.
vacuum packaged in clear plastic with color insert label, 6 pkgs/case
k) "Jalapeno Cheese For use in Low Protein and PKU Diets" 32 oz. 
vacuum packaged in clear plastic with color insert label, 6 pkgs/case.
Recall #F-321/331-9.

CODE
All codes of all products.

MANUFACTURER
Ener-G Foods, Inc., Seattle, Washington.

RECALLED BY
Manufacturer, by fax on March 12 and 16, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Hong Kong, England.

QUANTITY
Undetermined.

REASON
Products were not manufactured in a manner that would assure that could not support the growth of Clostridium botulinum.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
Heparin Sodium Injection, USP, 1000 units/mL, in 5mL ampul, for IV or SC use, Rx anticoagulant. NDC #0209-4220-14. Recall #D-156-9.

CODE
Lot #9703043 EXP 03/2000.

MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.

RECALLED BY
Manufacturer, by letter on December 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
19,925 units were distributed.

REASON
Particulate matter.

________
PRODUCT
Liothyronine Sodium, USP, bulk powder, sold in 500 mg, 1 gram, and 5 gram units, Rx for the treatment of hypothyroidism. NDC numbers: 38779-0031-0 (500 mg), 38779-0031-6 (1 g), 38779-0031-3 (5 g). Recall #D-157-9.

CODE
Lot #55007 EXP 06/00.

MANUFACTURER
Topchem S.R.L., Milano, Italy (bulk drug supplier).

RECALLED BY
Medisca, Inc., Plattsburgh, New York, by letter dated January 28, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
192.5 grams were distributed.

REASON
Mislabeling - The product is Levothyroxine Sodium, not Liothyronine Sodium as labeled.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT

Pediacare brand OTC products for pediatric use.  Labels for the first five products 
listed may state either McNeil Consumer Products Company Division of McNeil-PPC, Inc,
or Marketed by Pharmacia & Upjohn Consumer Healthcare.  The labels for the last two 
products listed state Marketed by Pharmacia & Upjohn Consumer Healthcare:
a) Pedia Care Cough-Cold liquid (Each 5 mL contains pseudoephedrine hydrochloride 
   15 mg, chlorpheniramine maleate 1 mg, and dextromethorphan hydrobromide 5 mg), 
   in 4 fluid ounce bottles;
b) Pedia Care Cough-Cold Chewables (Each tablets contains pseudoephedrine 
   hydrochloride 15 mg, chlorpheniramine maleate 1 mg, and dextromethorphan 
   hydrobromide 5 mg), 16 tablets;
c) Pedia Care NightRest Cough-Cold liquid (Each 5 mL contains pseudoephedrine 
   hydrochloride 15 mg, chlorpheniramine maleate 1 mg, and dextromethorphan 
   hydrobromide 7.5 mg), in 4 fluid ounce bottles;
d) Pedia Care Infants' Drops Decongestant (Each 0.8mL (dropperful) contains 
   pseudoephedrine hydrochloride 7.5 mg), in 1/2 fluid ounce (15mL) bottles;
e) Pedia Care Infants' Drops Decongestant Plus Cough (Each 0.8mL (dropperful) 
   contains pseudoephedrine hydrochloride 7.5 mg and dextromethorphan 
   hydrobromide 2.5 mg)), in 1/2 fluid ounce (15mL) bottles;
f) Pedia Care Fever liquid , Ibuprofen Oral Suspension, 100 mg per 5 mL (teaspoon),
   in 4 fluid ounce bottles;
g) Pedia Care Fever drops, Ibuprofen Oral Suspension, 50 mg per 1.25 mL 
   (dropperful), in 1/2 fluid ounce bottles.
Recall #D-158/164-9.

CODE
All lots at retail with coupons attached.

MANUFACTURER
Pharmacia & Upjohn, Kalamazoo, Michigan.

RECALLED BY
Manufacturer, by letter dated February 9, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
419,000 packages were distributed.

REASON
Mislabeling - Some units are overlabeled with an incorrect peel off coupon.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Human Tissue for Transplant: Corneas, Veins, and Musculoskeletal Tissue. Recall #B-571-9.

CODE
Donors 95-094, 97-191, 98-068.

MANUFACTURER
Upstate New York Transplant Services, Buffalo, New York.

RECALLED BY
Manufacturer, by letter either October 7, 8, 13, or 14,1998, or January 5 or 18, 1999, or by telephone on September 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York, Florida, New Jersey, Georgia.

QUANTITY
Tissues from 3 donors were distributed.

REASON
Tissues for transplant were incorrectly tested for HBsAg, or anti-HIV-1/2.

________
PRODUCT
Donor Management Information System, Version 1.2. Recall #B-602-9.

CODE
11 systems were distributed.

MANUFACTURER
Information Data Management, Rosemont, Illinois.

RECALLED BY
Manufacturer, by telephone on January 19, 1999. Firm-initiated recall complete.

DISTRIBUTION
New Jersey, Illinois, Ohio, South Carolina, Hawaii, Tennessee, Indiana, Hong Kong and the United Kingdom.

REASON
Y2K defect in the computer software incorrectly calculates the end date of a temporary deferral to be 1900 instead of 2000, and removes the deferral from the database.

________
PRODUCT
Recovered Plasma. Recall #B-621-9.

CODE
Unit #49FF33317.

MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.

RECALLED BY
Manufacturer, by fax on January 6, 1999. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with a history of cancer.

________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-622/623-9.

CODE
Unit #17183-3374.

MANUFACTURER
United Blood Services, McAllen, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 4, 1999, and by letter dated March 3, 1999. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of cancer.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Tissues for Transplant: Corneas, Veins, and Musculosketal Tissue. Recall #B-572-9.

CODE
Donor 97-239.

MANUFACTURER
Upstate New York Transplant Services, Buffalo, New York.

RECALLED BY
Manufacturer, by letter either October 7, 8, 13, or 14,1998, or January 5 or 18, 1999, or by telephone on September 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York, Florida, New Jersey, Georgia.

QUANTITY
Tissues from 1 donor was distributed.

REASON
Tissues for transplant were incorrectly tested for HBsAg, or anti-HIV-1/2.

________
PRODUCT
a) Autologous Red Blood Cells. Recall #B-600-9.

CODE
Unit numbers: 40J00191, 40J00192, 40J00193, 40J00194, 40J00195.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri (testing Laboratory).

RECALLED BY
American Red Cross Blood Services, Peoria, Illinois, by telephone and fax on March 2, 1999. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
5 units were distributed.

REASON
Autologous red blood cells were incorrectly tested for syphilis, were not labeled with a Biohazard label.

________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-620-9.

CODE
49FF33343, 49FM33092, 49GR09719, 49GR09721, 49GR09728, 49LF39752, 49LK12119, 49LQ01172, 49LQ01179.

MANUFACTURER
American Red Cross Blood Services, Waco, Texas.

RECALLED BY
American Red Cross Blood Services, Tulsa, Oklahoma, by telephone on September 25, 1998, and by letter dated October 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
9 units were distributed.

REASON
Leukocytes Reduced blood products were prepared using a filter that had not yet been validated by the blood collection facility.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
Millennium VG Nuclear Medicine Scanner, Model 2200967; Varicam Nuclear Medicine Scanner, Models 100-3101-0605 and 100-3101-0308. Recall #Z-745/747-9.

CODE
All serial numbers.

MANUFACTURER
Elscint Ltd., Haifa, Israel.

RECALLED BY
General Electric Medical System, Waukesha, Wisconsin, by instructions to replace the lateral gear box on February 20, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
187 units were distributed.

REASON
Excessive wear of the lateral motion gears was found on several Varicam/Millennium VG Systems. Failure of a lateral motion gear could allow the detector head to move/fall down without operator control.

________
PRODUCT
BBL Arysulfatase Broth (0.001M), used to differentiate mycobacteria based on their ability to produce arylsulfatase, used in a 3-day test to detect arysulfatase activity in rapidly growing mycobacteria. Recall #Z-763-9.

CODE
Catalog #4395654, Lot #1013B9NCIW EXP 7/1/99.

MANUFACTURER
Becton Dickinson Microbiology Systems, Madison, Wisconsin.

RECALLED BY
Becton Dickinson Microbiology Systems, Sparks, Maryland, by letter dated January 1999. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
130 boxes (10 tubes per box) were distributed.

REASON
False negative test results.

________
PRODUCT
BBL Motility Test Medium with TTC, used for the detection of motility of gram negative enteric bactilli. Recall #Z-764-9.

CODE
Lot #: 1013J8NZAF - Expiration date 01APR99, Catalog #4397921.

MANUFACTURER
Becton Dickinson Microbiology Systems, Sparks, Maryland.

RECALLED BY
Manufacturer, by telephone on April 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
10 boxes of 10 tubes each were distributed.

REASON
Lack of reaction to positive samples.

________
PRODUCT
Biological Indicator ProSpore, indicated for team sterilization (121 degrees C). Recall #Z-776-9.

CODE
Lot #PS-156.

MANUFACTURER
Raven Biological Laboratories, Inc., Omaha, Nebraska.

RECALLED BY
Manufacturer, by telephone on January 29, 1999. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, Switzerland,England, Brazil, Ireland, Japan.

QUANTITY
167 50-ampoule boxes and 40 10-ampoule boxes were distributed.

REASON
An incorrect package information sheet accompanied the device.

________
PRODUCT
I-125 SEEDS, a welded titanium capsule containing Iodine-125 adsorbed onto a silver rod. Recall #Z-777-9.

CODE
Model 6711, lot W82246, activity range 0.82-0.88 mCi.

MANUFACTURER
Medi-Physics, Inc., Arlington Heights, Illinois.

RECALLED BY
Nycomed Amersham Imaging, Princeton, New Jersey, by requesting return of the shipment of seeds from the one direct account on November 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Hampshire.

QUANTITY
70 seeds were distributed.

REASON
Some of the seeds in the shipment were outside of the labeled radioactivity range of 0.82-0.88 mCi.

________
PRODUCT
Orthopedic Bone Screws, used to only assist in healing and are not intended to replace normal body structures: a) Part No. 10025-60, 5.0mm Cannulated Cancellous Lag Screw, 60mm; b) Part No. 10025-55, 5.0mm Cannulated Cancellous Lag Screw, 55mm. Recall #Z-779/780-9.

CODE
Lot numbers: a) 99090; b) 99080.

MANUFACTURER
Alphatec Manufacturing, Inc., Palm Desert, California.

RECALLED BY
Manufacturer, by memorandum dated April 6, 1998. Firm-initaited recall complete.

DISTRIBUTION
Japan.

QUANTITY
a) 8 units; b) 19 units were distributed.

REASON
The screw with laser etching, Part No. 10025-60, is actually 55mm in length, and the screw with laser etching, Part No. 10025-55, is actually 60mm in length.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Biological Indicators, Spore Strips, Bacillus Subtilis var.Niger (ATCC 9372), for use determining the efectiveness of ethylene oxide or dry heat sterilization procedures. Recall #Z-778-9.

CODE
Lot #116392 EXP 8/2000.

MANUFACTURER
Raven Biological Laboratories, Inc., Omaha, Nebraska.

RECALLED BY
Manufacturer, by telephone on January 27, 1999. Firm-initiated recall complete.

DISTRIBUTION
Arizona, Puerto Rico, Germany, Italy, Japan, Canada.

QUANTITY
19,911 were distributed.

REASON
The glassine envelopes containing the individual spore strips were labeled with an incorrect lot number while the boxes are labeled with the correct lot number.

END OF ENFORCEMENT REPORT FOR APRIL 7, 1999.

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