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.
ENFORCE
11/15/1995
ENFORCEMENT REPORT FOR 11/14/95
November 15, 1995 95-46
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
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PRODUCT KC Strawberry Candy, individually wrapped hard candy in 16
ounce plastic bags. Recall #F-043-6.
CODE 9581/TMRG stamped on the back panel of each bag.
MANUFACTURER KC Confectionery Ltd., Trinidad & Tobago, W.I.
RECALLED BY Bills Dollar Stores, Inc., Jackson, Mississippi, by letter
issued on October 3, 1995. FDA-initiated recall ongoing.
DISTRIBUTION South, Southeast, and Midwestern United States.
QUANTITY 24,000 bags were distributed.
REASON The label is misleading because the nutrient facts on the
bag indicated "zero grams" of sugar, however, the ingredient
statement listed cane sugar and corn syrup.
_______________
PRODUCT Kennedy Gourmet Honey, Lemon and Mint Flavored Tea-Sickles,
tea spoons with confection coating on the end of the spoons
for flavoring tea and other beverages.
Recall #F-046-6.
CODE All lots.
MANUFACTURER Kennedy Candy Company, Inc., Kilgore, Texas.
RECALLED BY Manufacturer, by letter dated August 23, 1995. FDA-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 34,000 units were distributed.
REASON The product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Eddyleon Milk Chocolate Peanut Butter Cups Packaged in 4.5
ounce boxes, 3 boxes to a gift box. Recall #F-045-6.
CODE Lot #A3274.
MANUFACTURER Eddyleon Chocolate Company, Inc., Moosic, Pennsylvania.
RECALLED BY Manufacturer, by letter August 7, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 792 boxes were distributed; firm estimates none remains on
market.
REASON Sugar Free Peanut Butter Cups were packaged in containers
labeled as Milk Chocolate Peanut Butter Cups.
_______________
PRODUCT Standard White Salad Dressing, in individual plastic
packets. Recall #F-047-6.
CODE 03025, 03085, 03105, 03165.
MANUFACTURER Portion Pac, Inc., Mason, Ohio.
RECALLED BY Manufacturer, by telephone during the last week in March
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product is unfit for food due to swollen packages.
_______________
PRODUCT Rising Sun Farm brand Salad Vinaigrette and marinades in
12.5 fluid ounce glass jars:
(a) Oil free fresh pesto sun dried tomato salad vinaigrette
& marinade fat free
(b) Oil free italian lovers salad vinaigrette and marinade
(c) Oil free roasted sweet red pepper and sun dried tomato
salad vinaigrette and marinade
(d) Fresh pesto sun dried tomato vinaigrette and marinade.
Recall #F-048/051-6.
CODE Use by dates: (a-c) 1/7/96 - 9/20/96; (d) 7/3/96.
MANUFACTURER Rising Sun Farms, Inc., Phoenix, Oregon.
RECALLED BY Manufacturer, by letter and fax on May 27, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 35,131/12.7 fluid ounce bottles (5,855.17 cases;
(b) 19,418/12.7 fluid ounce bottles (3236.33 cases);
(c) 31,511/12.7 fluid ounce bottles (4812.67 cases;
(d) 35,131/12.7 fluid ounce bottles (5855.17 cases).
REASON The product is unfit for food due to fermentation caused by
lactobacillus .
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Children's APAP Acetaminophen Elixir, OTC analgesic, in 4
fluid ounce bottles under the Mason distributors, and
Genovese Drug Stores labels. Recall #D-013-6.
-2- CODE Lot #405099 EXP 1/97.
MANUFACTURER Hi-Tech Pharmacal Company, Inc., Amityville, New York.
RECALLED BY Manufacturer, by telephone in February/March 1995, followed
by letter October 26, 1995. Firm-initiated recall complete.
DISTRIBUTION New Jersey, Florida, California, New York.
QUANTITY 11,400 bottles were distributed.
REASON Superpotency.
_______________
PRODUCT Oxygen Cylinders with post valves coded 160995:
Emergency Portable Unit-Model 477-27-6; Filled aluminum
cylinders with Erie Post valve 870-models 488-60, 407-150,
407-127, 488-12; Post valve assemblies-models 480-3, 480-3-
16, 488-42, and 488-53. Recall #D-014-6.
CODE Cylinders with post valves coded 160995.
MANUFACTURER Erie Medical, Division of Erie Manufacturing Company,
Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter on or about October 6, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Colorado, Iowa, Illinois, Maryland, Michigan, Minnesota, New
York, Pennsylvania, Texas, Wisconsin, Portugal.
QUANTITY 513 cylinders were distributed.
REASON Improper assembly of temperature sensitive safety plug.
_______________
PRODUCT Oxygen USP in portable aluminum cylinders in the following
sizes: "E", 682 liters; "D", 425 liters, "M-9", 245 liters,
and "M-6" 165 liters. Recall #D-016-6.
CODE All codes distributed to patient accounts between April 1995
and September 1995.
MANUFACTURER Southeast Home Medical Equipment, Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by telephone between September 11 and 22,
1995. FDA-initiated recall ongoing.
DISTRIBUTION Wisconsin.
QUANTITY Undetermined.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
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PRODUCT Dexamethasone Tablets, USP, 0.75 mg Dosepack Tablets, 12
Oral Tablets per dosepack, Rx corticosteroid.
Recall #D-015-6.
CODE Lot #099501 EXP 9/96.
MANUFACTURER Par Pharmaceuticals, Inc., Spring Valley, New York.
RECALLED BY Horizon Pharmaceutical, Inc., Louisville, Kentucky, by
letter dated October 2, 1995. FDA-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Usage instructions are printed upside down on a portion of
the lots.
-3- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
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PRODUCT Recovered Plasma. Recall #B-023-6.
CODE Unit #35R72.
MANUFACTURER Mayo Foundation, Division of Transfusion Medicine,
Rochester, Minnesota.
RECALLED BY Manufacturer, by telephone on August 31, 1994, and by
follow-up letter on September 1, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida, New York, Italy.
QUANTITY 1 unit.
REASON Blood product, which initially tested reactive for antibody
to the hepatitis C virus encoded antigen (anti-HCV) and was
not retested in duplicate, was distributed.
_______________
PRODUCT Source Plasma. Recall #B-039-6.
CODE Unit #0180681543.
MANUFACTURER NABI Bio-Medical Center, Columbus, Ohio.
RECALLED BY Manufacturer. Unit was destroyed on March 9, 1994. Firm-
initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, which was tested HCV repeat reactive, was
distributed.
_______________
PRODUCT Platelets. Recall #B-044-6.
CODE Unit #03GL08130.
MANUFACTURER American Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on February 1, 1995, followed by
letter on February 7, 1995. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor with a
medical history of hepatitis, was distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-045-6.
CODE Unit numbers: 03P79224, 03P64491, 03P58046.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter dated February 24, 1995. Firm-
initiated recall complete.
DISTRIBUTION Georgia and Tennessee.
QUANTITY 3 units.
REASON Blood products, which were collected from a donor who had
traveled to an area designated as endemic for malaria, were
distributed.
-4- _______________
PRODUCT Baxter Fenwal Closed System Apheresis Kit with Double Return
Line Needle and PL 3014 Plastic Platelet Storage Containers,
designed for use with the CS-3000 Plus Blood Cell Separator
for the simultaneous collection of platelet concentrate and
plasma. Recall #B-049-6.
CODE Lot #H95F07016GM.
MANUFACTURER Baxter Healthcare Corporation, Mountain Home, Arkansas.
RECALLED BY Baxter Healthcare Corporation, Deerfield, Illinois, by
telephone on July 28, 1995, followed by letter dated July
31, 1995. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 66 kits were distributed.
REASON Baxter's Apheresis Kits, which were manufactured in a manner
that compromised the sterility of the collection system,
were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-050/051-6.
CODE Unit #L40555.
MANUFACTURER South Bend Medical Foundation, Inc., South Bend, Indiana.
RECALLED BY Manufacturer, by telephone on October 6, 1994, followed by
letter and fax on October 11, 1995. Firm-initiated recall
complete.
DISTRIBUTION Indiana, Pennsylvania, California.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for
hepatitis B surface antigen (HBsAg), were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-052/053-6.
CODE Unit #53GL48776.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letters dated December 15, 1993, March 15,
1995, May 1, 1995, and December 22, 1993. Firm-initiated
recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for antibody to the
hepatitis C virus encoded antigen (anti-HCV), but were
collected from a donor who previously tested repeatedly
reactive for anti-HCV on three separate occasions, were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Gesco brand 3.5 Fr. Umbili-Cath, a sterile, single-use,
prescription PVC umbilical vessel catheter.
Recall #Z-114-6.
-5- CODE Catalog #9823, Lot #06-032897.
MANUFACTURER Gesco International, Inc., subsidiary of MedChem Products,
Inc., San Antonio, Texas.
RECALLED BY MedChem Products, Inc., Woburn, Massachusetts, by letter
dated May 19, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada.
QUANTITY 1,140 units were distributed.
REASON The device was manufactured without a radiopaque stripe,
thus precluding radiographic confirmation.
_______________
PRODUCT Tabletops Installed with Tomoscan SR 6000 and SR 7000
Computed Tomography (CT) X-Ray Scanners:
(a) Tabletop 4520-540-01611 used with Tomoscan SR 6000
(b) Tabletop 4520-540-01711 used with Tomoscan SR 7000.
Recall #Z-129/130-6.
CODE Serial numbers: (a) 5001-5020; (b) 6001-6049.
MANUFACTURER Hitachi Medical Systems, Tokyo, Japan.
RECALLED BY Philips Medical Systems, Shelton, Connecticut, by issuing a
User Notification letter dated September 22, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 57 units; (b) 5 units.
REASON The method of applying the adhesive which bonds the carbon
fiber to core material may allow the eventual separation of
the carbon fiber from the core, weakening the tabletop, and
causing it to break or bend.
SEIZURE ACTIONS:
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PRODUCT Frozen Shrimp (95-681-946).
CHARGES Adulterated - The article consists in part of a decomposed
substance by reason of the presence therein of decomposed
shrimp.
LOCATION Americold Cold Storage, Tampa, Florida.
FILED September 26, 1995; U.S. District Court for the Middle
District of Florida; Civil #95-1575-CIV-T-24B; FDC #67101.
SEIZED October 26, 1995 - goods valued at approximately $25,000.
-6-
END OF ENFORCEMENT REPORT FOR NOVEMBER 15, 1995. BLANK PAGES MAY
FOLLOW.
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