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 contain s information on actions taken in connection with agency regulatory activities.

ENFORCE
08/07/1996

RECALLS AND FIELD CORRECTIONS

August 7, 1996 96-32

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Star Bake Shop Bread: (a) Italian Bread 16
ounces; (b) Garlic Bread with Romano Cheese, 9
ounces. Recall #F-637/638-6.
CODE Product manufactured through June 13, 1996.
MANUFACTURER Leon's Bakery, North Haven, Connecticut (raw
frozen dough).
RECALLED BY Star Markets Company, Inc., Cambridge,
Massachusetts, by telephone on June 13, 1996.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts, New Hampshire.
QUANTITY Firm estimates none remains on the market.
REASON Products contained undeclared dry egg whites.

_______________
PRODUCT Wavy Lays Original Potato Chips, in 6 ounce
bags. Recall #F-639-6.
CODE Jul 02 96.
MANUFACTURER Frito-Lay, Inc., Binghamton, New York.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by electronic
mail on May 29, 1996. Firm-initiated recall
complete.
DISTRIBUTION Virginia, District of Columbia, New York,
Pennsylvania, Delaware, Maryland, West
Virginia, New Jersey.
QUANTITY 156 cases (12 bags per case) were distributed;
firm estimates none remains on the market.
REASON Product contained undeclared egg yolk solids.
The bags actually contained Wavy Lays Hidden
Valley Ranch flavored potato chips.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Deux Mondes brand Les Olives Candy in 3 ounce
retail bags and Deux Mondes brand Pebbles from
the Mountain Candy, in 3 ounce retail bags.
Recall #F-627/628-6.
CODE None.
MANUFACTURER F. Marion Chocolatier, Oraison, France.
RECALLED BY Deux Mondes Import/Export Company,
Minneapolis, Minnesota, by telephone on June
28, 1996. Firm-initiated recall complete.
DISTRIBUTION Minnesota, Washington state.
QUANTITY 72 retail packages of each product were
distributed.
REASON Product contains undeclared FD&C Yellow No. 5
and carbon black.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Blueberry Fruit Syrup, in 750 ml bottles under
the following labels: Naturola, Campina,
Tropico. Recall #F-625-6.
CODE None.
MANUFACTURER Caribe Tropical Corporation, San Sebastian,
Puerto Rico.
RECALLED BY AC Packers Corporation, Guaynabo, Puerto Rico,
by visit July 1-5, 1996. Firm-initiated
recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 180 bottles were distributed.
REASON Product contains undeclared FD&C Blue No. 1.

_______________
PRODUCT Minute Maid Citrus Punch, in 64 fluid ounce
table top cartons. Recall #F-626-6.
CODE AUG 12 W-3L-1 ZZ:ZZ, AUG 12 W-4L-1 ZZ:ZZ
AUG 12 W-3L-2 ZZ:ZZ, AUG 12 W-4L-2 ZZ:ZZ
[Note - "ZZ:ZZ" refers to a 24 hour code].
Case Code - 08/12/96.
MANUFACTURER West Lynn Creamery, Lynn, Massachusetts.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visit on
or about June 28, 1996. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts.

-2-QUANTITY 240 cases (6 cartons per case) were
distributed.
REASON Product contains undeclared color additives
and bears the incorrect juice content.

_______________
PRODUCT Enchant brand Sweetened Flavorings in 3.5
ounce canisters with tin-plate crimp bottom
seal and plastic shaker top:
(a) Strawberry Flavoring; (b) Hazelnut
Flavoring; (c) Cappuccino Flavoring; (d) Peach
Flavoring; (e) Vanilla Almond; (f) Chocolate
Mint. Recall #F-630/635-6.
CODE Lot numbers: (a) 664041; (b) 462221
(c) 264011; (d) 862221; (e) lot 362213
(f) 162221.
MANUFACTURER CF Technologies, Inc., Pentwater, Michigan.
RECALLED BY Manufacturer, by letter dated July 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Michigan and Ohio.
QUANTITY Approximately 9,600 canisters were
distributed.
REASON Product was contained in containers with a
defective bottom seal.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Xactdose Phenytoin Oral Suspension, USP, 100
mg/4 ml unit dose cups, anticonvulsant.
Recall #D-217-6.
CODE Lot numbers: 508608 and 508613 EXP 2/97.
MANUFACTURER Parke-Davis, Division of Warner-Lambert
Company, Morris Plains, New Jersey.
RECALLED BY Xactdose, Inc., South Beloit, Illinois
(repacker), by letter dated July 16, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,947 cases were distributed; firm estimated
that 10-15% of the product remained on the
market at time of recall initiation.
REASON Due to large particle size, some of the unit
doses may not meet potency specifications.

_______________
PRODUCT Kanamycin Sulfate Injection USP, Rx
aminoglycoside antibiotic for I.V. or
intramuscular injection for the short-term
treatment of serious infections caused by E.
coli, Proteus sp., Enterobacter aerogenes,
Klebsiella pneumoniae, Serratia marcescens and
Acinetobacter sp., 10 vials per shelf carton:

-3- (a) 1 g/3 ml - Catalog #06305, 3 ml single
dose vial; (b) 250 mg/ml - Catalog #06402,
2 ml single dose vial. Recall #D-218/219-6.
CODE Lot numbers: (a) 951269, 960104, 960256; (b)
951270, 960155, 960250.
MANUFACTURER SoloPak Laboratories Inc., Elk Grove Village,
Illinois.
RECALLED BY Manufacturer, by letter dated July 26, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 154,620 vials were distributed; firm estimated
that 84% of product remained on market at time
of recall initiation.
REASON Inadequate microbial controls for the raw
material.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-554/557-6.
CODE Unit numbers: (a) 1878693, 6049334, 7811187;
(b) 1878693, 7811187; (c) 1878693, 7811187;
(d) 6049334.
MANUFACTURER LifeSource Blood Services, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated February 23,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Illinois.
QUANTITY (a) 3 units; (b) 2 units; (c) 2 units;
(d) 1 unit.
REASON Blood products collected from a donor who
previously tested HCV reactive and was not
deferred.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-565/567-6.
CODE Unit #5009350.
MANUFACTURER North Jersey Blood Center, East Orange, New
Jersey.
RECALLED BY Manufacturer, by telephone on December 21,
1994, followed by letter dated December 22,
1994. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit of each component.
REASON Blood products collected from a donor with a
history of ear piercing within the previous 12
months.

-4-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =====
_______________
PRODUCT Red Blood Cells. Recall #B-568-6.
CODE Unit numbers: 29135-0974 and 29135-0979.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on May 13, 1996,
followed by letter dated May 31, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Blood products remained at room temperature
for an unacceptable length of time.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Cardiac SPECT Pallet Kit, Item #1758320, used
to conduct cardiac SPECT studies utilizing
Technetium radionuclides. Recall #Z-989-6.
CODE All kits shipped between 10/01/94 and 3/7/96.
MANUFACTURER Siemens Medical Systems, Inc., Nuclear
Medicine Group, Hoffman Estates, Illinois.
RECALLED BY Manufacturer, by sending copies of the
Operators Manuals with a letter of explanation
dated March 8, 1996. Firm-initiated field
correction complete.
DISTRIBUTION Michigan, Ohio, Tennessee, Minnesota, New
Jersey, Georgia, Missouri, California.
QUANTITY 11 units were distributed and corrected by
supplying the missing manuals.
REASON The cardiac pallet kits did not include the
operating instructions manual, publication
#17-58-155, Revision 01 (March 1992).

_______________
PRODUCT Centurion Laser Shower System, for veterinary
use only: pain therapy, accelerated healing
(biostimulation). Recall #Z-1000-6.
CODE None.
MANUFACTURER Centurion Systems, Inc., Edison, New Jersey.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan July 23, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 83 units were distributed.
REASON Non-compliance with performance standards for
laser products in that it lacked a remote
interlock connector, adequate emission delay
and certain labeling information.

-5-_______________
PRODUCT Dade Actin Activated Cephaloplastin Reagent
(APAC), for use in the determination of the
activated partial thromboplastin time and
other coagulation procedures requiring an
activated partial thromboplastin reagent:
(a) Catalog #291011; (b) Catalog #B4218-2;
(c) Catalog #B4218-999.
Recall #Z-1001/1003-6.
CODE Lot numbers: (a) APAC-622A EXP 12/18/97;
(b) APAC-622B EXP 12/18/97;
(c) APAC-622C EXP 12/18/97.
MANUFACTURER Dade International of Puerto Rico, Aguada,
Puerto Rico.
RECALLED BY Dade International, Inc., Miami, Florida, by
letter January 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,281 packages were distributed.
REASON The lots may give prolonged activated partial
thromboplastin times with heparinized
controls, resulting in test results higher
than expected.

_______________
PRODUCT Graham Field White Latex Finger Cots, sizes
small, large and ex-large, also distributed
under DMI label:
(a) Graham Field White Latex Finger Cots,
Catalog Number 88-3910S-D;
(b) Graham Field White Latex Finger Cots,
Catalog Number 88-3810L;
(c) Graham Field White Latex Finger Cots,
Catalog Number 88-3910XL;
(d) Graham Field White Latex Finger Cots,
Catalog Number 88-3910XL-D.
Recall #Z-1006/1009-6.
CODE Catalog numbers: 88-3910L and 88-3910XL, and
Private label numbers 88-3910S-D and
88-3910XL-D.
MANUFACTURER Seohung Industrial Co.,Ltd., Seoul, Korea.
RECALLED BY Graham Field Inc., Hauppauge, New York, by
letter dated June 26, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,577 gross were distributed.
REASON The finger cots failed the FDA's WEAC analysis
of sample #1999024 for water leaks upon entry
into the United States. The finger cots
contain embedded particles, adhering surfaces,
and fail to meet the ASTM standards for
dimensional requirements.

-6-_______________
PRODUCT Swivel Elbow without Suction Port and Ultraset
Flex Tube Adapter Assembly, used between
tracheal tubes and ventilator circuits to
provide sectioning access or easy
repositioning of the circuitry:
(a) Swivel Elbow without Suction Port,
Reorder/Part #DHD 66-1995,
(b) Ultraset Flex Tube Adapter Assembly (with
Double Swivel Elbow without Port) Reorder/Part
#DHD 66-2509. Recall #Z-1010/1011-6.
CODE Lot numbers: (a) 613501; (b) 613108.
MANUFACTURER DHD Diemolding, Wampsville, New York.
RECALLED BY DHD Diemolding Healthcare Division, Canastota,
New York, by telephone beginning June 17,
1996, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Massachusetts, New Jersey, New York,
Pennsylvania, Minnesota, Illinois, Texas,
California, Washington state.
QUANTITY 77 cases (50 units per case) were distributed.
REASON The devices may contain swivel elbows with an
open port (completely open).

_______________
PRODUCT Linescan System Eight A Cabinet X-ray System,
used for security screening of baggage and
parcels. Recall #Z-1012-6.
CODE Model No. SYS 108A (also known as Model No.
LS8A-GY).
MANUFACTURER EG&G, Astrophysics Research Corporation, Long
Beach, California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan May 31, 1996. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 8 units.
REASON The cabinet x-ray system failed to comply with
the Federal cabinet x-ray system performance
standard, in that the product did not have
adequate indicator lights and failed to have a
means to ensure operator presence, required
for systems used in public areas.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Coatest brand Heparin Test Kit, used for the
determination of heparin in plasma.
Recall #Z-1005-6.
CODE Kit Lot #X2513 EXP 01 May 1998, Buffer Lot
#X1911 05 98.

-7-MANUFACTURER Pharmacia Hepar, Inc., Franklin, Ohio.
RECALLED BY Manufacturer, by letter July 19, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION California, Florida, Wisconsin, North
Carolina, Pennsylvania, Maine, Maryland,
Illinois, Minnesota.
QUANTITY 39 kits were distributed.
REASON The buffer lot number was stated incorrectly
as X1119 on the kit carton label.

-8-

END OF ENFORCEMENT REPORT FOR AUGUST 7, 1996. BLANK PAGES MAY FOLLOW.

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