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
02/28/1996

ENFORCEMENT REPORT FOR 02/28/96

February 28, 1996 96-09

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Quality Farm & Fleet and CT Farm & Country
brands of Circus Peanuts; a marshmallow type
candy in clear plastic bags with twist ties
ranging in weight between 0.6 and 0.7 pounds
placed in 20 pound cases. Recall #F-044-6.
CODE Lot number SK085066B.
MANUFACTURER Melster Candies, Inc., Cambridge, Wisconsin.
RECALLED BY Rucker's Wholesale & Service Co., Inc.,
Bridgeport, Illinois (repacker), by telephone
on August 21, 1995. Firm-initiated recall
complete.
DISTRIBUTION Michigan, Ohio, Illinois, Iowa, Missouri.
QUANTITY 224 cases were distributed; firm estimated
that 100 cases remained on market at time of
recall initiation.
REASON Product is unfit for food due to a very hot
spicy taste.

________________
PRODUCT Original gourmet cookies:
(a) Original Gourmet Macadamia Nut, 1.6
ounces; (b) Original Gourmet Chocolate Chunk
Cookie, 1.6 ounces; (c) Original Gourmet
Oatmeal Raisin 1.6 ounces; (d) Original
Gourmet Peanut Butter 1.6 ounces.
Recall #F-276/279-6.CODE Code dates 011596 and before.
MANUFACTURER Hazelwood Farms Bakeries, Inc., Hazelwood,
Missouri.
RECALLED BY Hazelwood Farm Bakeries, Inc., Atlanta,
Georgia, by letter sent August 3, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,104 cases; (b) 3,754 cases; (c) 2,463;
(d) 1,734 cases were distributed.
REASON Product has an off flavor and odor.

_______________
PRODUCT Nature's Bounty brand Melatonin, 200 mcg, in
60 tablet bottles, a dietary supplement.
Recall #F-292-6.
CODE Lot #37984-02, Product #7900.
MANUFACTURER Kabco, Inc., Amityville, New York.
RECALLED BY Puritan's Pride Natural Vitamins, Bohemia, New
York, by letter sent December 11, 1995,
followed by telephone on December 12, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,286 bottles were distributed.
REASON Bottles of 3 mg. melatonin tablets are labeled
as containing 200 mcg melatonin.

_______________
PRODUCT King David's brand Mediterranean salads and
dips: (a) Homous, in 8 ounce jars;
(b) Super Garlic Homous, in 8 ounce jars
(c) Dill Homous, in 8 ounce jars;
(d) Hot Homous, in 8 ounce jars;
(e) Jalapeno Homous, in 8 ounce jars;
(f) Roasted Red Pepper Homous, in 8 ounce
jars;
(g) Scallion Homous, in 8 ounce jars;
(h) Pimento & Olive Homous, in 8 ounce jars;
(i) Babaganouge, in 16 ounce jars;
(j) Tabbouleh, 8 ounce jars.
Recall #F-293/302-6.
CODE All lots.
MANUFACTURER King David's Restaurant, Syracuse, New York.
RECALLED BY Manufacturer, by letter faxed on October 25,
1995, and by visits and/or telephone. New
York State Department of Health issued a press
release. Firm-initiated recall complete.
DISTRIBUTION New York and Connecticut.
QUANTITY 3,726 containers were distributed.
REASON Products were prepared, packaged, and held
under insanitary conditions at the
manufacturer.

-2-_______________
PRODUCT Hi-C Hula Punch, in 10 packs of 8.45 ounce
tetra brik packages. Recall #F-303-6.
CODE Pull date codes SEP 12 96TJ, SEP 13 96TJ, SEP
14 96TJ.
MANUFACTURER Coca-Cola Foods, Paw Paw, Michigan.
RECALLED BY Coca Cola Foods, Houston, Texas, by telephone
on December 19, 1995, followed by visit.
Firm-initiated recall ongoing.
DISTRIBUTION Iowa, Illinois, Indiana, Kansas, Kentucky,
Michigan, Minnesota, Missouri, North Dakota,
Nebraska, Ohio, Virginia, Wisconsin, West
Virginia.
QUANTITY 14,467 cases were distributed; firm estimates
none remains on the market.
REASON Product is contained in leaking containers and
contaminated with yeast organisms.

_______________
PRODUCT Sugarfree Vines Licorice Candy, contained in
clear plastic bags of variable weights with
twist ties, placed in 10 pound cases.
Recall #F-304-6.
CODE Lot numbers **085066C and **085066D, where the
first two digits are the initials of the
repacker.
MANUFACTURER American Licorice, Alsip, Illinois.
RECALLED BY Rucker's Wholesale & Service Company, Inc.,
Bridgeport, Illinois (repacker), by telephone
in September 1995, followed by visit and
memorandum sent October 15, 1995 and January
2, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New York, Maryland, Delaware,
Indiana, Virginia, Michigan, West Virginia,
Ohio.
QUANTITY 50 cases were distributed; firm estimated that
less than 10 packages remained on market at
time of recall initiation.
REASON The sugarfree licorice was inadvertently
labeled with the ingredient statement for the
regular licorice which lists corn syrup and
sugar.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Guaifenesin/Codeine Phosphate Cough Syrup, 100
mg/10 mg per 5 ml, OTC schedule V narcotic
expectorant cough suppressant, in 1 pint
bottles, under the following labels: MGP
Mytussin AC Cough Syrup;, GG Glydeine Cough
Syrup. Recall #D-087-6.

-3-CODE Lot #20490 EXP 4/97.
MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton
Grove, Illinois.
RECALLED BY Manufacturer, by letter dated February 20,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,765 pints were distributed; firm estimated
less than 200 pints remained on market at time
of recall initiation.
REASON Potency of the codeine ingredient not assured
through expiration date.

_______________
PRODUCT Goldline brand of Potassium Chloride Extended
Release Tablets, USP, 750 mg, in 100 count
bottles. Recall #D-088-6.
CODE Lot #27J4724.
MANUFACTURER Upsher-Smith Laboratories, Inc., Minneapolis,
Minnesota.
RECALLED BY Zenith Goldline Pharmaceuticals (formerly
Goldline Labs), Fort Lauderdale, Florida, by
letter sent November 14, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 3,800 boxes were distributed.
REASON Package insert incorrectly declares color of
tablets as yellow instead of white.

_______________
PRODUCT Cetacaine Topical Anesthetic Spray, in 56 g.
size bottles, a topical anesthetic spray.
Recall #D-089-6.
CODE Lot numbers 324-337, inclusive EXP dates 12/95
through 3/97.
MANUFACTURER Cetylite Industries, Inc., Pennsauken, New
Jersey.
RECALLED BY Manufacturer, by letter mailed week of
November 13, 1995, and December 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 12,249 units were distributed;
firm estimated that 7,249 units remained on
market at time of recall initiation.
REASON Potency of tetracaine ingredient not assured
through expiration date.

_______________
PRODUCT Arthritis Hot Pain Relief Cream, in a 3 ounce
metal tub, OTC analgesic. Recall #D-090-6.
CODE Lot numbers: GAH0394A EXP 2/1/96, GAH0394B,
GAH0394C, GAH0394D, GAH0394E.

-4-MANUFACTURER G & W Laboratory, Inc., South Plainsfield, New
Jersey.
RECALLED BY Thompson Medical Company, Inc., Fairfield, New
Jersey, by letter on September 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 73,896 tubs were distributed; firm estimates
none remains on the market.
REASON Subpotency.

_______________
PRODUCT Sublimaze (Fentanyl Citrate), Rx Class II
controlled drug for injection, a narcotic
analgesic. Recall #D-091-6.
CODE Lot numbers: 53B007 EXP 2/96, 53D020 EXP
4/96, 54E100 EXP 5/97.
MANUFACTURER Akorn Manufacturing Inc., Decatur, Illinois.
RECALLED BY Janssen Pharmaceutica, Inc., Titusville, New
Jersey (responsible firm), by letter dated
November 28, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Lot #53B007 - 21,965 ampoules (4,393 cartons)
Lot #53D020 - 23,795 ampoules (4,759 cartons)
Lot #54E100 - 28,155 ampoules (5,631 cartons)
were distributed.
REASON Product does not meet impurity specifications.

HUMAN TISSUE MANDATORY RECALLS ==============================
_______________
UPDATE Human Tissue from Cadaveric Donors, Intended
for Human Transplantation, Recall #B-532-5,
which appeared in the September 20, 1995
Enforcement Report listed an incorrect donor
number of 122194; and delete donor number
080593. The correct listing should be 121994.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelet Concentrate;
(c) Fresh Frozen Plasma; (d) Cryoprecipitated
AHF; (e) Recovered Plasma; (f) Red Blood
Cells, for further manufacture; (g) Platelets,
for further manufacture. Recall #B-227/233-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1070 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.

-5-RECALLED BY Manufacturer, by letters from August 10, 1994
through July 31, 1995, and from January 5,
1995 through December 29, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Washington state, Oregon, Alaska, Florida,
Illinois, New Jersey, New York, California,
Switzerland.
QUANTITY Numerous units.
REASON Blood products which tested repeatedly
reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1) or
the hepatitis B surface antigen (HBsAg); or
tested negative for anti-HIV-1 or HBsAg, but
were collected from donors who previously
tested repeatedly reactive for anti-HIV-1 or
HBsAg, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-236/237-6.
CODE Unit #49J60638.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, (a) by letter dated April 20,
1994; (b) by telephone on April 19, 1995.
Firm-initiated recall complete.
DISTRIBUTION (a) Oklahoma; (b) California.
QUANTITY 1 unit of each component.
REASON Blood product, collected from a donor
currently taking the drug, Proscar, was
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-240/241-6.
CODE Unit #4504445.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter dated August 30, 1995.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the
antibody to the hepatitis C virus encoded
antigen (anti-HCV), but were collected from a
donor who previously tested repeatedly
reactive for anti-HCV, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-242-6.
CODE Unit #49F61615.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.

-6-RECALLED BY Manufacturer, by letter dated February 23,
1995. Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had
traveled to an area designated as endemic for
malaria, was distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-252/253-6.
CODE Unit #24GS38596.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letter dated July 12, 1995.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially
reactive for the hepatitis B surface antigen
(HBsAg), and were not retested in duplicate,
were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-243-6.
CODE Unit #N28708.
MANUFACTURER East Texas Blood Center, Nacogdoches, Texas.
RECALLED BY Manufacturer, by telephone on August 9, 1995.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, labeled with an extended
expiration date, was distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-251-6.
CODE Unit numbers: 25Z76339, 25Z76329, 25Z40188,
25Z76020, 25Z40663.
MANUFACTURER American Red Cross Blood Services, Syracuse,
New York.
RECALLED BY Manufacturer, by telephone on May 10, 1995,
followed by letter dated May 19, 1995. Firm-
initiated recall complete.
DISTRIBUTION New York.
QUANTITY 5 units.
REASON Blood products stored at an unacceptable
temperature were distributed.

-7-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Pacemaker Leads and Adapter Sleeves:
(a) ACCUFIX(tm) Pacing Lead, Models 033-201
and 033-202; ACCUFIX(tm) II DEC Pacing Lead,
Model 033-212; ENCOR(R) Pacing Lead, Models
033-301, 330-158, 330-258; ENCOR(R) DEC Pacing
Lead, Models 033-159, 330-443, 033-448;
ENCOR(R) Epicardial Pacing Lead, Model
033-452; ENGUARD(r) Pacing Lead, Models
040-068, 040-068-65; HIFLEX(tm) Pacing Lead,
Model 033-458; LASERDISH(tm) Pacing Lead,
Models 033-441, 033-442, 033-444
(b) Adapter Sleeves, Models 033-260, 033-320,
331-220, 331-270, 331-300.
Recall #Z-441/442-6.
CODE Each unit has a unique serial number. There
are approximately 1,460 non-sequential serial
numbers.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes,
Florida.
RECALLED BY Telectronics Pacing Systems, Englewood,
Colorado, by sending packages which includes a
letter dated January 10, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, France, Germany,
Australia.
QUANTITY (a) 1,274 unimplanted units in the US; (b) 117
unimplanted units in the US; and 30,034 units
foreign.
REASON The devices have been manufactured by the firm
knowingly using non-conforming polyurethane
tubing which is used as insulation material on
the leads and adapters.

_______________
PRODUCT Heat and Moisture Exchangers, used to preserve
humidity and tracheal cellular morphology,
reduction of water and heat losses through
bronchopulmonary tree, and telp to prevent
thickened secretions, mucosal damage and
changes in lung function during long-term
anesthesia or ventilatory support: (a)
Catalog #002840; (b) Catalog #002840P; (c)
Catalog #002841; (d) Catalog #VVC-1062.
Recall #Z-449/452-6.
CODE Lot numbers: MBXU00121, 001832, 001936,
002475, 2J036, 2M313, 3A305, 3B183, 3C324,
3E562, 3F295, 3H262, 3K271, 3M408, 3M441,
4A154, 4A464, 4C363, 4D482, 4D627, 4E185,
4F340, 4F642, 4M0871, 4M169, 5B0057, 5C0588,
5D0627, 5H0424, 5K0117, 5B0748, 5E0498,

-8- 5G0466, 2E179, 2H475, 2K602, 3E563, 4E079,
4F3482, 4M0872, 4M170, 5A0591, 5B0410, 5D0628,
5E0365, 5H0425, 4522, and 5D1033.
MANUFACTURER Intertech, Fort Myers, Florida.
RECALLED BY Manufacturer, by letter sent beginning on
December 18, 1995, and a second letter
beginning on January 15, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON The foam media can separate from its frame
and block the breathing circuit airway.

_______________
PRODUCT Bronchial Double Lumen Tube Set, used in lung
surgery. Recall #Z-453-6.
CODE Catalog #11600370, Lot #95/25/0.
MANUFACTURER Rusch, Inc., A.G., Kernen, Germany.
RECALLED BY Rusch, Inc., Duluth, Georgia, by fax,
telephone, and letter dated October 25 & 26,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 78 sets were distributed.
REASON The bronchial and tracheal funnels were
incorrectly assembled.

_______________
PRODUCT Valleylab E2530 Series Sterile Disposable
Flexible ArgonPlus Electrodes and E2580 Series
Sterile Disposable Retractable Laparoscopic
ArgonPlus Electrodes: (a) E2530-3, 3 inch,
coagulation only electrode;
(b) E2530-6, 6 inch, coagulation only
electrode;
(c) E2530-9, 9 inch, coagulation only
electrode;
(d) E2530-28, 11 inch, coagulation only
electrode;
(e) E2530-36, 14 inch, coagulation only
electrode;
(f) E2580-28, 11 inch, blade electrode;
(g) E2580-36, 14 inch, blade electrode;
(h) E2581-28, 11 inch, flat L electrode;
(i) E2581-36, 14 inch, flat L electrode;
(j) E2582-28, 11 inch, sharp needle electrode;
(k) E2582-36, 14 inch, sharp needle electrode;
(l) E2583-28, 11 inch, blunt needle electrode;
(m) E2583-36, 14 inch, blunt needle electrode.
Recall #Z-458/470-6.
CODE All lots.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, by letter January 1996. Firm-
initiated recall ongoing.
-9-DISTRIBUTION Nationwide and international.
QUANTITY 16,960 units were distributed.
REASON The slide adjustment on the E2520H disposable
handset used with these devices is not
adequately described in the labeling to
prevent a potential risk to safety in that the
electrodes can be pushed forward on the nose
of the handset, causing a break in the gas
seal between the electrode and the handset
which can pose a potential for an unintended
current path at the site of the leak with a
risk of burns to the patient or surgeon.

_______________
PRODUCT Umbilical Cable, Part #72-20-02-296, for the
Automix 3+3 Compounder. Recall #Z-471-6.
CODE All cables distributed prior to 1/15/96.
MANUFACTURER Baxter Healthcare, Largo, Florida
(compounder); V-Tron Electronics, Corporation,
South Attleboro, Massachusetts (cable).
RECALLED BY Clintec Nutrition Company, Deerfield,
Illinois, by letter January 23, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,800 pumps were distributed.
REASON A faulty cable causes the pump motors to run
out of sequence which may result in
incorrectly prepared admixtures.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Asnis 2 Guided Screw System:
(a) Asnis 2 Guided Screw, 5mm diameter X 60 mm
length, Catalog #3550-4-060; (b) Asnis 2
Guided Screw, 5mm diameter X 36 mm length,
Catalog #3550-4-036. Recall #Z-413/414-6.
CODE (a) Lot Code: BSNRW; (b) Lot Code: BSNRU.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by letter dated September 18,
1994. Firm-initiated recall complete.
DISTRIBUTION (a) California, New Jersey, New York, West
Virginia, South Carolina, Georgia, Florida,
Ohio, Indiana, Michigan, Missouri, Kansas,
Colorado, Puerto Rico, Ireland, Argentina; (b)
New Jersey, New York, North Carolina, Georgia,
Florida, Indiana, Arizona, Alabama, Oregon,
Washington state, Ireland.
QUANTITY (a) 41 units; (b) 29 units were distributed;
firm estimates none remains on the market.

-10-REASON The labels for the screws were switched during
packaging. Lot BSNRW is labeled as a 60 mm
screw, but actually contains a 36 mm screw.
Lot BSNRU is labeled as a 36 mm screw, but
actually contains a 60 mm screw.

_______________
PRODUCT Hex Drive Self Tapping Bone Screw 6.2mm
diameter x 40mm length, used with acetabular
cup fixation and total knee base plate
fixation.
Recall #Z-415-6.
CODE Catalog #6290-5-040, lot #CLVKB.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by letter dated September 8,
1994. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Virginia, Indiana, Texas,
Arizona, California, Rhode Island, New Jersey,
Pennsylvania, Maryland, West Virginia, South
Carolina, Florida, Indiana, Michigan,
Nebraska, Texas, Ireland.
QUANTITY 46 units were distributed; firm estimates none
remains on the market.
REASON The package label does not reflect the package
contents. Lot CLVKB is labeled as a 40mm
screw, but actually contains a 30mm screw.

_______________
PRODUCT Small Alta Tibial Countersink, used in
orthopedic surgery. Recall #Z-416-6.
CODE Catalog #5255-6-180, label date code 90312.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by letter dated April 17, 1995.
Firm-initiated recall complete.
DISTRIBUTION New Jersey, Oklahoma, Alabama, Arkansas.
QUANTITY 9 units were distributed; firm estimates none
remains on the market.
REASON The package label does not reflect the package
contents. Product with the label date code of
90312 is labeled as a Small Alta Tibial
Countersink but it actually contains a Large
Alta Femoral Countersink.

_______________
PRODUCT Flexible IM Reamer, 11mm diameter x 400mm
length, used in orthopedic surgery.
Recall #Z-417-6.
CODE Catalog #3210-0-110, label date code 94311.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by letter April 17, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Colorado.

-11-QUANTITY 5 units were distributed; firm estimates none
remains on the market.
REASON The package label does not reflect the package
contents. The Flexible IM Reamer is labeled
with a size of 11mm diameter X 400mm length
but it actually contains an 11mm diameter X
300mm length reamer.

-12-

END OF ENFORCEMENT REPORT FOR FEBRUARY 28, 1996. BLANK PAGES MAY
FOLLOW.

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