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
09/17/1996
ENFORCEMENT REPORT FOR 09/18/96
September 18, 1996 96-38
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Frozen cookie dough pellets and frozen cheese
cake chunks extruded and cut to dimensions and
utilized as an add-in for further processing
into ice cream/yogurt/ice milk products,
fudge, etc.:
(a) AF-01-500 Non Coated Chocolate Chip Add
In, in 20 pound boxes
(b) AF-01-501 Coated Chocolate Chip Add In, in
20 pound boxes
(c) AF-01-505 Coated Low Fat Fudge Brownie Bit
Add In, in 20 pound boxes
(d) AF-01-509 Coated Premium No Chip Add In,
in 40 pound boxes
(e) AF-01-511 Coated Chocolate Chip Add In, in
40 pound boxes
(f) AF-01-517 Coated Chocolate Chip Natural
Add In, in 40 pound boxes
(g) AF-01-550 Coated Fudge Brownie Bit Add
In, in 40 pound boxes. Recall #F-694/700-6.
CODE All misbranded product.
MANUFACTURER Rhino Foods, Inc., Burlington, Vermont.
RECALLED BY Manufacturer, by telephone on July 10, 1996,
followed by letter dated July 11, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Connecticut, Massachusetts, New Hampshire, New
Jersey, New York, Ohio, Pennsylvania, Vermont,
Wisconsin, District of Columbia.
QUANTITY Estimate of Inventory in the Field:
AF-01-500 - 163 cases
AF-01-501 - 382 cases
AF-01-505 - 737 cases
AF-01-509 - 353 cases
AF-01-511 - 215 cases
AF-01-517 - 309 cases
AF-01-550 - 571 cases.
REASON Products were shipped without ingredient
statements and contained liquid pasteurized
eggs. The products contain undeclared eggs.
_______________
PRODUCT Genesee Farms Cookie Dough Ice Cream, in 3-
gallon tubs. Recall #F-708-6.
CODE 6184.
MANUFACTURER Genesee Farms, Attica, New York.
RECALLED BY Genesee Farms, Batavia, New York, by letters
on August 9, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY 76 tubs were distributed.
REASON Product contains undeclared eggs.
_______________
PRODUCT Kellogg's Frosted Bran Cereal, 18.9 ounce box.
Recall #F-717-6.
CODE "Better if used before" date of "APR 26 1997
NA 009" printed on the boxtop.
MANUFACTURER Kellogg Company, Omaha, Nebraska.
RECALLED BY Kellogg Company, Battle Creek, Michigan, by
press release on August 13, 1996, and by visit
beginning on August 14, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, Connecticut, Florida, Georgia,
Indiana, Kentucky, Massachusetts, Maine,
Michigan, Mississippi, New Jersey, New York,
North Carolina, Ohio, Pennsylvania, South
Carolina, Tennessee, Virginia, West Virginia.
QUANTITY Approximately 4,400 cases (12 boxes per case)
were distributed.
REASON Product contains undeclared peanuts.
-2- RECALLS AND FIELD CORRECTIONS: CLASS II ====================
_______________
PRODUCT Frozen cookie dough pellets and frozen cheese
cake chunks extruded and cut to dimensions and
utilized as an add-in for further processing
into ice cream/yogurt/ice milk products,
fudge, etc.:
(a) AF-01-507 No Fat Coated Chocolate Chip
Add In, in 20 pound boxes
(b) AF-01-514 Coated No Egg No Chip Add In,
in 40 pound boxes, in 40 pound boxes
(c) AF-01-603 Coated No Egg Chocolate Chip
Coconut Add In, 40 pound boxes
(d) AF-01-605 Coated No Egg Chocolate Chip
Add In, in 40 pound boxes
(e) AF-01-700 Coated Cheesecake Add In, in 20
pound boxes. Recall #F-701/705-6.
CODE All misbranded product.
MANUFACTURER Rhino Foods, Inc., Burlington, Vermont.
RECALLED BY Manufacturer, by telephone on July 10, 1996,
followed by letter dated July 12, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Connecticut, Massachusetts, New Hampshire, New
Jersey, New York, Ohio, Pennsylvania, Vermont,
Wisconsin, District of Columbia.
QUANTITY Estimate of inventory in the field:
AF-01-507 - 248 cases
AF-01-514 - 204 cases
AF-01-603 - 30 cases
AF-01-605 - 430 cases
AF-01-700 - 26 cases.
REASON Products were shipped without ingredient
statements and contained undeclared wheat
flour.
_______________
PRODUCT Lay's Regular Potato Chips, in 1.5 ounce vend
size bags. Recall #F-713-6.
CODE OCT 15 434206 1.5 ounce vend size Lay's
regular potato chips.
MANUFACTURER Frito-Lay, Inc., Louisville, Kentucky.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by telephone
beginning August 12, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Indiana.
QUANTITY 84 cases (36 bags per case) were distributed.
REASON Product contains undeclared dairy ingredients
and bears an inappropriate identity statement.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
-3- _______________
PRODUCT Zia Maria's Italian Spaghetti Sauce, in 16
ounce glass jars with one-piece metal screw-on
lids. Recall #F-691-6.
CODE Uncoded.
MANUFACTURER Palmieri Food Products, Inc., New Haven,
Connecticut.
RECALLED BY Zia Maria's, Inc., Minden, Nebraska, by
telephone on June 4, 1996, and by television
broadcast on June 4 & 5, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nebraska.
QUANTITY 14 cases (12 jars per case) were distributed.
REASON Some jars have popped up lids and are spoiled.
_______________
PRODUCT Tortellini with Cheese Filling Plain and
Tortellini with Cheese Filling Tricolor, in 8
ounce bags and 2.2 pound bags.
Recall #F-692/693-6.
CODE All codes.
MANUFACTURER Audisio Ind. Alim. S.R.L., Italy.
RECALLED BY California Specialty Food Importers, Inc.,
Chatsworth, California (importer), by
telephone, August 9, 1996, followed by letter
sent August 13, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION California, Nevada, Washington state.
QUANTITY 38 cases (6 2.2-pound bags and 22 cases (24 8-
ounce bags per case) were distributed.
REASON Product does not list a complete ingredient
statement and contains undeclared hot pressed
peanut oil.
_______________
PRODUCT Various Ocean Spray Cranberry Juices, in 1
gallon plastic bottles: (a) Ocean Spray
Cranberry Juice Cocktail; (b) Ocean Spray
Cranapple Cranberry Apple Juice Drink; (c)
Ocean Spray Cran-Raspberry Raspberry Cranberry
Juice Drink; (d) Ocean Spray Ruby Red
Grapefruit Juice Drink. Recall #F-709/712-6.
CODE Cap Codes: (a) 03037K....LTPCJ2 and
03047K....LTPCJ2; (b) 03047K....LTPCA2; (c)
03057K....LTPCR2; (d) 03057K....LTPRR2 &
03067K....LTPRR2.
MANUFACTURER Ocean Spray Cranberries, Inc., Kenosha,
Wisconsin.
RECALLED BY Ocean Spray Cranberries, Inc., Lakeville-
Middleboro, Massachusetts, by memorandum on
August 22, 1996, followed by visit. Firm-
initiated recall ongoing.
-4- DISTRIBUTION Nationwide.
QUANTITY 20,913 cases (6 bottles per case) were
distributed.
REASON Product is contaminated with mold.
_______________
PRODUCT Aloha Maid iced tea, lemonade, and fruit
drink, in 20 fluid ounce plastic bottles: (a)
Iced Tea; (b) Strawberry Flavored Lemonade;
(c) Orange Passion Fruit Drink.
Recall #F-714/716-6.
CODE (a) Open date code: 960605A, B or C, and
960607B; (b) 960606E, F, or G, and 960607A;
(c) 960606A, B, C, or D.
MANUFACTURER Cliffstar Corporation, Fontana, California.
RECALLED BY Itoen (USA), Inc., Honolulu, Hawaii, by visit
and by telephone beginning on August 14, 1996,
and by press release on August 16, 1996.
Firm-initiated recall complete.
DISTRIBUTION Hawaii and Guam.
QUANTITY Firm estimates none of the May or June 1996
production remains on market.
REASON Product is unfit for food based on off-taste,
alcohol-like taste and leaks.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Thiothixene HCl Capsules, USP, 1 mg, 2 mg and
5 mg strength, packed in bottles of 100, under
the Schein and Rugby labels, an antipsychotic.
Recall #D-263/265-6.
CODE 1 mg, Lot numbers: C5C0227, CXB104, CXC104
2 mg, Lot numbers: C5C0231
5 mg, Lot numbers: C5E0809, C5E1128, C5E1129
(Schein label)
1 mg, Lot numbers: CXB104, CXC104
2 mg, Lot numbers: C5C0231 (Rugby label).
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Danbury Pharmacal, Inc., Subsidiary of Schein
Pharmaceutical, Inc., Brewster, New York, by
letter dated July 31, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 28,710 bottles (1 mg); 9,513 bottles (2 mg);
26,752 bottles (5 mg) were distributed.
REASON Dissolution failure.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =====
_______________
PRODUCT Red Blood Cells. Recall #B-625-6.
CODE Unit numbers: L50665, L50666.
-5- MANUFACTURER South Bend Medical Foundation, Inc., South
Bend, Indiana.
RECALLED BY Manufacturer, by telephone on or about July
21, 1995. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 2 units were distributed.
REASON Blood products were mislabeled with an
incorrect expiration date.
_______________
PRODUCT Red Blood Cells. Recall #B-626-6.
CODE Unit numbers: 38J35701, 38J35702, 38J35704,
38J35705, 38J35706, 38J35707.
MANUFACTURER American Red Cross, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by telephone on April 13, 1995.
Firm-initiated recall complete.
DISTRIBUTION Ohio, Tennessee, Indiana.
QUANTITY 6 units were distributed.
REASON Blood products were mislabeled with an
incorrect expiration date.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Mobile/Portable General Purpose Units, used in
radiographic studies:
(a) Model HP200; (b) HP300.
Recall #Z-1101/1102-6.
CODE HP200 and HP300 mobile/portable general
purpose systems containing the R-120 series
collimators.
MANUFACTURER Mikasa X-Ray Co LTD., Tokyo, Japan.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on September 9, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 40 units.
REASON Noncompliance with performance standards for
diagnostic x-ray products in that the units
failed to meet light illuminance requirement
at a source to image distance (SID) of 40
inches and they failed to meet edge contrast
ratio requirement at an SID of 40 inches.
_______________
PRODUCT Transmucosal Implant Extensions, endosseous
implant accessories used for dental
restoration surgery:
(a) Second Phase Set, Catalog No. 8246S; 4.0
mm Diameter x 4.0 mm High;
(b) Transmucosal Implant Extension (TIE)
Catalog No. 8265A, 4.0 mm Diameter x 4.0 mm
High. Recall #Z-1133/1134-6.
-6- CODE Lot Numbers: (a) 302406, 307908, 301311,
413002, 413704, 409106, 421206, 412908,
407809, 417209, 404210, & 416510; (b) 305909,
412909, 413503, 405704, 400905, 407606,
422006, 407606, 412508.
MANUFACTURER Interpore International, Irvine, California.
RECALLED BY Manufacturer, by letters on January 31, 1995.
and March 10, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Mexico, Lebanon, Canada, Taiwan.
QUANTITY 1,926 units were distributed; firm estimated
that little if any product remained on market
at time of recall initiation.
REASON The packaging labels were labeled as 4.0 x 1.0
mm IMC Titanium Inserts when the packages
actually contained products with a 4.0 x 4.0
mm Transmucosal Implant Extension.
_______________
PRODUCT Bactec Instrument 460 TB Drug Susceptibility
Testing Instructional Manual.
Recall #Z-1144-6.
CODE All lot numbers.
MANUFACTURER Becton Dickinson Diagnostic Instrument
Systems, Sparks, Maryland.
RECALLED BY Manufacturer, by Important Technical Bulletin.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Puerto Rico.
QUANTITY 657 manuals were distributed.
REASON The manual for the device contains inadequate
instructions of use.
_______________
UPDATE Davis-Geck Valtrac Bar Biofragmentable
Anastomosis Ring, Recall #Z-1043/1051-6 which
appeared in the August 28, 1996, Enforcement
Report listed an incorrect product number for
item (b). The correct product number is
8083-00.
RECALLED BY also failed to provide the
following information: Sherwood Medical
Company, St. Louis, Missouri, issued two
letters dated May 22, 1996, to U.S. accounts
and a letter dated May 23, 1996, to foreign
accounts, requesting return of only Control
No. 894100 of Product No. 8083-00, and that
the consignees examine all other lot numbers
(Control Nos.) of all Product Numbers listed
for proper orientation of the device. Any
device found not properly oriented was not to
be used, but returned for replacement. Firm-
initiated field correction ongoing.
-7- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Human Albumin, 30% Solution Nonsterile,
Catalog #3110, for use in laboratory research
or manufacturing non-injectable products only.
Recall #Z-984-6.
CODE Lot #4001657.
MANUFACTURER Biocell Laboratories, Inc., Rancho Dominguez,
California.
RECALLED BY Manufacturer, by telephone on June 11, 1993.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 40 50-ml vials were distributed; firm
estimates none remains on the market.
REASON The device fails to meet it's labeling
specification of 3 ml. It was determined that
the device was bottled 2 ml short.
_______________
PRODUCT Hip Stem Endoprosthesis:
(a) Sentry, Catalog No. 6258-5-008, 5 Right,
250mm Length, 15.5mm Diameter;
(b) Sentry, Catalog No. 6258-5-005, 4 Right,
250mm Length, 15.5mm Diameter;
(c) Sentry, Catalog No. 6258-4-012, 5 Left,
250mm Length, 21.5mm Diameter;
(d) Austin Moore, Catalog No. 6940-9-400,
Labeled 9" in Length. Recall #Z-1127/1130-6.
CODE Lot Codes: (a) ATMNB; (b) CHXZA; (c) CHTZA;
(d) OKYVA.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, (a) by fax on November 17, 1995;
(b) by fax on January 10, 1996; (d) by fax on
December 7, 1995. Firm-initiated recall
complete.
DISTRIBUTION (a) Massachusetts, New Jersey, Virginia; (b)
Minnesota, California, (c) Virginia; (d)
Minnesota.
QUANTITY Amount shipped: (a) Lot code: ATMNB - 4
units, CCKFA - 0 units, (b) Lot code: CHXZA -
2 units; (c) Lot code: CHTZA - 1 unit; (d) Lot
code: OKYVA - 2 units.
REASON Packaging, labeling, and sizing mix-ups led to
packages with incorrect labeling or product.
_______________
PRODUCT Head and Neck Replacement (HNR) Log Stem,
Catalog #6257-2-300. Recall #Z-1131-6.
CODE Lot Code COGSC.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by fax on February 21, 1996.
Firm-initiated recall complete.
-8- DISTRIBUTION Pennsylvania, West Virginia, Georgia,
Michigan, Washington state, Ohio.
QUANTITY 8 units were distributed.
REASON Instead of containing a 200 mm x 43 mm long
stem as labeled, the package may contain a 225
mm x 43 mm long stem.
_______________
PRODUCT Package insert associated with Dade
Immunoassay Control Comprehensive Tri-Level
Kit, in-vitro diagnostic kit used to assist in
monitoring accuracy and precision in clinical
assays: (a) Catalog Nos. B5700-05, B5700-S;
(b) Catalog No. B5700-06; (c) Catalog No.
B5700-07; (d) Catalog No. B5700-08.
Recall #Z-1135/1138-6.
CODE Lot Numbers: (a) IACK-28; (b) IAC1-128;
(c) IAC2-228; (d) IAC3-328. All kits expire
on March 26, 1998.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter dated June 1996
containing corrected package insert. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide and Italy.
QUANTITY 10,776 kits were distributed.
REASON The package insert had multiple
inconsistencies that included an incorrect
assay range.
_______________
PRODUCT Incstar FTA-ABS Flouro Test Kit, in-vitro
diagnostic for detecting antibodies in human
serum to syphilis: (a) - Catalog No. 1910; (b)
Catalog No. 1910G; (c) Catalog No. 6910; (d)
Incstar FTA-ABS Test Sorbent, Catalog No.
1866. Recall #Z-1139/1142-6.
CODE Lot Numbers: (a) 115516, 115606A, 175436,
175446, 195796, 215126, 195796B, 142016,
142016A, 205356, 205356A, 265356, 265376,
295196, 265366;
(b) 142016, 142016A, 205356, 205356A;
(c) 115506, 175426A, 175436A, 175416, 195796A,
215216A, 265376A, 295196A;
(d) 122156, 122156A, 122156B.
MANUFACTURER Incstar Corporation, Stillwater, Minnesota.
RECALLED BY Manufacturer, by letter on August 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Incstar FTA-ABS Fluoro Test Kits, product
numbers 1910, 1910G and 6910: 587 of the test
kits were distributed. Incstar FTA-ABS Test
Sorbent, product number 1866: 30 of the test
kits were distributed.
-9- REASON Some negative samples may yield a positive
assay response.
_______________
PRODUCT C. Albicans Growth Promotion Test Suspension,
Catalog #GP-03, used for USP growth promotion
testing. Recall #Z-1149-6.
CODE Lot numbers: GCA010-010, GCA010-012.
MANUFACTURER North American Science Associates (NAMSA),
Northwood, Ohio.
RECALLED BY Manufacturer, by letter August 28, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Ireland, Japan, Singapore.
QUANTITY 110 vials were distributed.
REASON There was a reduction in spore population
below the labeled range.
_______________
PRODUCT EP Medical Electrophysiology Catheters 2mm and
2, 5, 2mm electrode spacing intended for ECG
recording, intercardiac pacing, stimulation
and sensing in sterile form:
(a) Model EPM-64-SC-252; (b) Model
EPM-64-HD-2; (c) Model EPM-64-SC-2.
Recall #Z-1150/1152-6.
CODE Lot #95117, use before 6/97.
MANUFACTURER ProCath Corporation Subsidiary of EP Medical,
Inc., Berlin, New Jersey.
RECALLED BY Manufacturer, by letter on October 17, 1995,
and January 19, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 21 catheters were distributed.
REASON The tubing weld joints may separate if handled
forcefully prior to insertion. The separation
of the tubing weld joint can result in a loss
of torque of the distal tip curve. A loss of
torque would render the catheter ineffective.
_______________
PRODUCT VAI Cultureset Herpes Simplex Virus (HSV)
Identification Kit 501020, Immunoperoxidase
Staining Kit for use with Viral Tissue Culture
Isolation, for in-vitro diagnostic use.
Recall #Z-1145-6.
CODE Lot 106, EXP 26 MAY 97.
MANUFACTURER VAI Diagnostic, Memphis, Tennessee.
RECALLED BY Manufacturer, by telephone or letter on June
21, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 224 kits were distributed.
-10- REASON The device has exhibited an unexpected drop in
the reactivity of the labeling reagent,
included in the kit. As a result, the
intensity of staining in positive samples may
reduced.
_______________
PRODUCT Osteonics Omnifit Cup Insert series, sterile,
implantable, non-critical Rx devices:
(a) Osteonic Omnifit 10 Degree cup Insert
Series I, 28 mm, Catalog #2002-2854; (b)
Osteonics Omnifit 20 Degree Cup Insert Series
II, 26 mm, Catalog #2042-2654.
Recall #Z-1153/1154-6.
CODE (a) Case # 1NCGW; (b) Case #1NCGM.
MANUFACTURER Osteonics Corporation, Allendale, New Jersey.
RECALLED BY Manufacturer, by telephone on April 22, 1996,
followed by letter on April 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 24 units; (b) 11 units were distributed.
REASON The 20 degree labeled package may contain the
10 degree unit, and vice-versa.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
============
_______________
PRODUCT Gentamicin Sulfate Solution, 100 mg/ml, for
the control of bacterial infections of the
uterus in horses and as an aid in improving
conception in mares with uterine infections
caused by bacteria sensitive to gentamicin.
Recall #V-039-6.
CODE Lot #51618 EXP JAN 98.
MANUFACTURER Rhone Merieux, Inc., Fort Dodge, Iowa.
RECALLED BY Rhone Merieux, Inc., Athens, Georgia, by
letter dated July 25, 1996. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 11,040 250-ml vials were distributed.
REASON Precipitate in the product.
-11-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 18, 1996. BLANK PAGES MAY FOLLOW.
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