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
01/25/1995
Recalls and Field Corrections: Foods -- Class I -- 01/25/1995
January 25, 1995 95-4
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Sugarcreek brand Swiss Cheese, in 4 or 8 pound blocks.
Recall #F-192-5.
CODE Cut date of 09-30-94 or 93094 and 10-22-94 or 02294.
MANUFACTURER Union Cheese Company, Sugarcreek, Ohio.
RECALLED BY Manufacturer, by telephone October 28, 1994, followed by
letter October 31, 1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 2,270 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Grape juices, in 25.4 fluid ounce bottles, 12 bottles per
case: (a) Pinot Noir Grape Juice; (b) Muscato Grape Juice.
Recall #F-189/190-5.
CODE Cases ink-jetted with production dates September 17 and
September 18 for the Pinot Noir juice; October 27 and
October 28 for the Muscato juice. Older cases May have code
"217A93.
MANUFACTURER Rombauer Vinyards, St. Helena, California.
RECALLED BY Napa Valley Kitchens, Napa, California, by letter December
7, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY Approximately (a) 621 cases; (b) 45 cases were distributed.
REASON Product contains undeclared sulfites.
_______________
PRODUCT Haggen brand Hearty Nut Bread, in 24 ounce plastic bags.
Recall #F-191-5.
CODE All product manufactured prior to September 24, 1994.
MANUFACTURER United States Bakery, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by hand delivered notices September 24, 1994.
Firm-initiated recall complete.
DISTRIBUTION Washington State.
QUANTITY Firm estimates none remains on the market.
REASON Product contained undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS I
======================
_______________
PRODUCT Sea Therapy Mineral Eye Gel and Mask, in 2 ounce and 1/4
ounce bottles. Recall #F-193-5.
CODE None.
MANUFACTURER The American Tea Company, Inc., doing business as Lily of
Colorado, Henderson, Colorado.
RECALLED BY Manufacturer, by telephone, letter, and by visit to local
stores beginning the week of November 21, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Colorado, California, Michigan, and other stores scattered
throughout the Midwest.
QUANTITY Undetermined.
REASON Product is contaminated with Pseudomonas aeruginosa and
Pseudomonas fluorescens bacteria.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Alupent (metaproterenol sulfate USP) Inhalation Complete
with mouthpiece, 200 metered doses, Rx used in the treatment
of asthma. Recall #D-050-5.
CODE Lot numbers: 930181A, 930183A, 930184B, 930184C, 930732B.
MANUFACTURER 3-M Pharmaceuticals, Inc., Northridge, California.
RECALLED BY Boehringer-Ingelheim Pharmaceuticals, Ridgefield,
Connecticut, by letter January 9, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 75,034 units of lot 930181A, 71,566 units of lot 930183A,
59,048 units of lot 930184B, 7,845 units of lot 930184C,
12,128 units of lot 930732B were distributed.
REASON Product does not meet particle size specifications.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Anacin Coated Analgesic Tablets, OTC, in 2 and 12 count
tins. Recall #D-046-5.
CODE Lot numbers: K310 EXP 9/97, K311 EXP 9/97, K312 EXP 9/97,
K315 EXP 9/97 (tins of 12); H301 EXP 8/97, K307 EXP 9/97
(tins of 2).
MANUFACTURER Whitehall Robins, Hammonton, New Jersey.
RECALLED BY Manufacturer, by letter dated April 4, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 113,400 tablets were distributed.
REASON Product does not meet content uniformity specification for
caffeine ingredient.
_______________
PRODUCT Momentum Muscular Backache Formula Caplets, OTC analgesic,
in bottles of 24. Recall #D-047-5.
CODE Lot #A321 EXP 9/96.
MANUFACTURER Whitehall Robins, Division of American Home Products
Corporation, Hammonton, New Jersey.
RECALLED BY Manufacturer, by letter dated April 4, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 212,688 tablets were distributed; firm estimates none
remains on market.
REASON Product does not meet stability specification for
disintegration.
_______________
PRODUCT Dristan 12-hour Nasal Spray, in 1/2 fluid ounce bottles, OTC
nasal spray. Recall #D-048-5.
CODE Lot numbers: A328 EXP 7/95, A329 EXP 7/95, C325 EXP 9/95,
C326 EXP 9/95, C329 EXP 9/95, C330 EXP 9/95, C331 EXP 9/95,
D301 EXP 9/95, D302 EXP 9/95, D305 EXP 9/95, D306 EXP 9/95,
D307 EXP 9/95, D308 EXP 10/95.
MANUFACTURER Whitehall Robins, Inc., Division of American Home Products
Corporation, Hammonton, New Jersey.
RECALLED BY Whitehall-Robins, Inc., Division of American Home Products
Corporation, Madison, New Jersey, by letters of November 2,
1993, and December 20, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 36,496 dozen bottles were distributed; firm estimates none
remains on market.
REASON Warning statement on immediate container label did not
appear on unit carton.
_______________
PRODUCT Preparation H Hemorrhoidal Suppositories, OTC rectal
vasoconstrictor suppository, in 12, 24, 36 and 48 count
cartons. Recall D-049-5.
-3- CODE Lot numbers: 93-308, 93-319, 93-322, 93-323.
MANUFACTURER Whitehall Robins, Division of American Home Products
Corporation, Hammonton, New Jersey.
RECALLED BY Manufacturer, by letter April 4, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON Preservative ingredient is marginally subpotent.
_______________
PRODUCT Amantadine Hydrochloride Capsules, USP, 100 mg, Rx oral drug
for the prevention or chemoprophylaxis of and the treatment
of respiratory tract illness. Recall #D-051-5.
CODE Lot #4K921 EXP 2/96.
MANUFACTURER Chase Laboratories, Newark, New Jersey.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois, by letter
January 12, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,262 cartons of 100 unit dose capsules were distributed;
firm estimated that 50% of the product remained on market at
time of recall initiation.
REASON Product does not meet USP content uniformity specifications.
_______________
PRODUCT Regular Strength Acetaminophen Tablets, 325 mg, packaged in
100 and 1000 tablet bottles, then repackaged under the
Goldline and Kerr labels. Recall #D-052-5.
CODE Lot numbers: 4092125 (Goldline label); 4081786 (Kerr
label).
MANUFACTURER Granutec, Inc., Wilson, North Carolina.
RECALLED BY Manufacturer, by letter December 21, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida, North Carolina, Ohio.
QUANTITY 6.2 million tablets were distributed.
REASON Presence of metallic particles in the product.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Siemens Conventional Mevatron Linear Accelerator System,
used to provide teletherapy x-ray beams for the treatment of
cancer. Recall #Z-254-5.
CODE Various serial numbers.
MANUFACTURER Siemens Medical Systems, Inc., Concord, California.
RECALLED BY Manufacturer, by letter June 14, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 800 units.
REASON A design defect in the software allows the entry, and
acceptance of erroneous treatment parameters when using the
Mevatron LINAC System.
-4- _______________
PRODUCT RMS-2000 Radiation Management System. Recall #Z-258-5.
CODE All units.
MANUFACTURER Varian Associates, Inc., Oncology Systems, Palo Alto,
California.
RECALLED BY Manufacturer, by visits from February 1993 to March 1993.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 50 units.
REASON A bug in the system's Novelle Netware (ver 3.11) caused the
overwriting of system memory, resulting in system crashes on
two separate cases.
_______________
PRODUCT Clinac Medical Linear Accelerators:
(a) Model CL 12-8; (b) Model CL-12-10;
(c) Model CL 18-20; (d) Model CL 1800;
(e) Model CL 2100 C. Recall #Z-259/263-5.
CODE (a) All units; (b) All units; (c) All units; (d) Serial
numbers 001-215; (e) Serial numbers 001-033.
MANUFACTURER Varian Associates, Inc., Oncology Systems, Palo Alto,
California.
RECALLED BY Manufacturer, by letter April 21, 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 400 units.
REASON A carousel misalignment caused several incidences of random
transverse beam asymmetry. In each case of asymmetry, the
system failed to detect the error.
_______________
PRODUCT Medrad Disposable Syringes, fluid delivery products,
packaged as (a) CT TRI-Paks; (b) 200 ml Fasturn Syringes.
Recall #Z-252/253-5.
CODE Lot numbers: (a) 940812, 940814 EXP 8/99;
(b) 940707 EXP 7/99.
MANUFACTURER Medrad, Inc., Indianola, Pennsylvania.
RECALLED BY Medrad, Inc., Pittsburgh, Pennsylvania, by telephone on
March 22, 1994, and April 15, 1994. Firm-initiated field
correction complete.
DISTRIBUTION California, Colorado, Florida, Kentucky, Tennessee, Utah,
Virginia.
QUANTITY 96 packaged devices.
REASON The sterility of the device has been compromised by a loss
of package integrity, i.e. lack of assurance of seal
strength due to variation in the adhesive transfer during
manufacture.
_______________
PRODUCT Image Receptor Support Device (IRSD), Model 4512-590-12681,
used to provide breast cancer screening and/or diagnosis
through radiography of the breast. Recall #Z-299-5.
CODE Serial numbers: None.
-5- MANUFACTURER Lorad Corporation, Danbury, Connecticut.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan December 21, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24 units.
REASON The fourth position of the Automatic Exposure Control (AEC)
Detector in the IRSD was insufficiently leaded and
transmission limit exceeded 0.100 mR per hour resulting in
noncompliance with the Federal performance standard for x-
ray products.
_______________
PRODUCT Auto Suture Premium CEEA Disposable Stapler, Low Profile
Anvil, for use in colo rectal surgery, as well as
laparoscopically assisted surgery for creation of end-to-
end, end-to-side, and side-to-side anastomosis.
Recall #Z-301-5.
CODE Reorder #111925. Lot numbers: P4D81, P4F120, P4F139,
P4F154, P4F167, P4F184, P4F188, P4F190, P4F191, P4F222,
P4F224, P4G40, P4H07, P4H16, P4H22, P4H88, P4H239, P4J15,
P4J25, P4J68, U4E31.
MANUFACTURER United States Surgical Corporation, Norwalk, Connecticut.
RECALLED BY Manufacturer, by visit October 7, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 11,010 units.
REASON The Low Profile Anvil head can come off during firing.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Allergan "Resolve/GP" Daily Cleanser for cleaning Rigid Gas
Permeable and Hard Contact Lenses:
(a) Resolve/GP Daily Cleaner in 30 ml bottles, Part #515;
(b) Resolve/GP Daily Cleaner in 5 ml bottles;
(c) WET-N-SOAK KIT, Part #6635 (contains 5 ml bottle);
(d) WET-N-SOAK KIT, Part #180KT (contains 5 ml bottle);
(e) WET-N-SOAK KIT, Part #854 (contains 5 ml bottle).
Recall #Z-270/274-5.
CODE Lot numbers: (a) 4542X, 4543X, 4544X, 4545X, 4547X, 4548X,
4549X, 4550X, 4551X, 7005X, 7006X and 7007X;
(b) 4522X, 4523X, 4524X, 4525X, 4526X, 4527X, 4550X, 7005X;
(c) 21X26, 21X66, 22X22, 22X24, 22X26, 22X28, 22X30, 22X43;
(d) 18X50, 19X14, 19X29, 19X79, 20X37, 20X86, 20X89;
(e) 20X44, 21X81, 22X78.
MANUFACTURER Allergan America, Hormigueros, Puerto Rico.
RECALLED BY Allergan, Inc., Irvine, California, by letter November 9,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Russia.
QUANTITY Approximately 293,960 bottles were distributed; firm
estimated that 50,000 bottles remained at time of recall
initiation.
-6- REASON: The Resolve/GP Daily Cleaner was misformulated to contain
less than the required amount of one of its surfactant
ingredients and does not meet its physical appearance
specifications.
_______________
PRODUCT ELISA Serology Test Kits: (a) Herpes Simplex Virus 1 IgM
ELISA Serology Test Kit, Catalog #2305450, for the detection
of IgM antibodies to Herpes Simplex virus 1 antigen in human
serum; (b) Chlamydia Trachomatis IgG ELISA Serology Test
Kits, Catalog #2306200, for the detection of IgG antibodies
to Chlamydia trachomatis antigen in human serum; (c) Mumps
IgG ELISA Serology Test Kits, Catalog #2305900 for the
detection of IgG antibodies to Mumps antigen in human serum,
for vitro diagnostic use. Recall #Z-275/277-5.
CODE Lot numbers: (a) #ST23-88, 723-88 EXP 6/95; (b) 737-35 EXP
6/95; (c) 728-38 EXP 6/95.
MANUFACTURER Clark Laboratories, Inc., Jamestown, New York.
RECALLED BY Manufacturer, by fax dated September 19, 1994. Firm-
initiated recall complete.
DISTRIBUTION Maryland, Florida, Greece, Turkey, Chile, Mexico, Israel,
Australia, Portugal, Spain.
QUANTITY (a) 608 units; (b) 98 units; (c) 214 units were distributed.
REASON The absorbance values for controls and specimens are lower
than expected.
_______________
PRODUCT Spottest Voges-Proskauer Reagent A, in-vitro diagnostic kit
used for determining the ability of bacteria to produce
acetylmethyl carbinol as an end product of glucose
metabolism. Recall #Z-278-5.
CODE Product #3558. Lot #54333JA.
MANUFACTURER Difco Laboratories, Mausten, Wisconsin (repacker).
RECALLED BY Repacker, by letter sent on or about October 20, 1994.
Firm-initiated recall complete.
DISTRIBUTION Kentucky, Texas, New Jersey, Georgia, Florida, Illinois,
Michigan, Ireland, Finland, Greece, Taiwan.
QUANTITY 88 boxes.
REASON The label on the product incorrectly states the device is
Spottest Voges-Proskauer Reagent B.
_______________
PRODUCT QBC Centrifuge Power Supply, 120/220 volt, supplied with the
QBC Centrifuge: (a) QBC Centrifuge, Catalog #424740;
(b) QBC Centrifuge Power Supply supplied as a replacement
part, Catalog #42474004. Recall #Z-279/280-5.
CODE Serial numbers: (a) 278001 through 279185;
(b) 02940853 through 03941999.
MANUFACTURER Becton Dickinson, Primary Care Diagnostics, Sparks,
Maryland.
RECALLED BY Manufacturer, by letter on or about October 10, 1994. Firm-
initiated recall ongoing.
-7- DISTRIBUTION Nationwide.
QUANTITY 1,034 units were distributed.
REASON A defective component in the power supply may produce a
visual flash and smoke.
_______________
PRODUCT Precise hCg Test Kit used in the detection of human
chorionic gonadotropin (hCG) in urine specimens for the
early detection of pregnancy: (a) Catalog #496220, 200 and
40 test kits; (b) Catalog #496240, 200 and 40 test kits.
Recall #Z-281/282-5.
CODE Lot numbers greater than 3411.
MANUFACTURER Becton Dickinson Advanced Diagnostics, Sparks, Maryland.
RECALLED BY Manufacturer, by letter dated September 26, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,971 units were distributed.
REASON False positive results in excess of expected specificity
levels of 99.5%.
_______________
PRODUCT Peptostreptococuss Anaerobius ATCC 27337, Bacti Disk, an in-
vitro diagnostic product recommended for use in laboratory
quality assurance procedures. Recall #Z-309-5.
CODE Lot #1532.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on or about July 28, 1994, and by
fax dated August 4, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Australia, Canada.
QUANTITY Firm estimates none remains on the market.
REASON An additional colony type (Peptostreptococcus SPP) was
present upon rehydration.
_______________
PRODUCT Loefflers Medium Slant Tubes, an in-vitro diagnostic used in
the cultivation of Corynebacterium Diphtheriae.
Recall #Z-310-5.
CODE Lot #1842 EXP 5/31/95.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone August 1, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Texas, Missouri, Oklahoma.
QUANTITY 140 tubes were distributed; firm estimates none remains on
the market.
REASON The medium is a broth instead of a slant.
_______________
PRODUCT EDMS Anaerocult C-Mini Set, Mini Sachets and Incubation
Bags, an in-vitro diagnostic product packed 25 sachets and
incubation bags per box. Recall #Z-311-5.
CODE Catalog #53-13699. Lot #35199.
MANUFACTURER EM Diagnostic Systems, Gibbstown, New Jersey.
-8- RECALLED BY Remel Limited Partnership, Lexena, Kansas, by telephone May
9, 1994. Firm-initiated field correction complete.
DISTRIBUTION Maryland, Massachusetts, Delaware, Michigan, Virginia, North
Carolina, California, Kansas.
QUANTITY 50 units were distributed.
REASON The actual expiration date was 6/30/94 and was correct on
the outside box, but the individual product was relabeled
with an expiration date of 11/30/94.
_______________
PRODUCT Fibrinogen Reagents and Veronal Buffer, used for
quantitative determination of fibrinogen in human serum for
coagulation studies: (a) Dade Owren's Veronal Buffer,
Catalog B4234-25; (b) Dade Data-F Fibrinogen Determination
Reagents, Catalog #B4233-15. Recall #Z-315/316-5.
CODE Lot numbers: (a) OW-204B, OW-205A; (b) FDK-528, FDK-529,
FDK-530.
MANUFACTURER Baxter Diagnostic of Puerto Rico, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by letter June
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 64,629 vials; (b) 5,908 packages were distributed.
REASON When either of the two lots of buffer were used as a diluent
in the fibrinogen determination, the control values were out
of range when read against a calibration curve constructed
with another lot number of buffer.
_______________
UPDATE Olympus Disposable Snares, Recall #Z-242/245-5, which
appeared in the January 18, 1995 Enforcement Report should
read:
QUANTITY: 33,960 units were distributed.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Vedco Carbam 200 mg film coated tablets, (diethylcarbamazine
citrate), packaged in bottles of 200, Rx used in the
prevention of heartworm disease in dogs and as an aid in the
treatment of ascarid infections in dogs and cats and as an
aid in the control of ascarid infections in dogs.
Recall #V-009-5.
CODE Lot #1200027.
MANUFACTURER Sanofi Animal Health, Inc., LeSueur, Minnesota.
RECALLED BY Sanofi Animal Health, Inc., Overland Park, Kansas, by letter
dated November 14, 1994, followed by telephone November 17,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Missouri.
QUANTITY 3,331 bottles were distributed.
REASON One case of product was found to contain unlabeled bottles.
-9- _______________
PRODUCT Lactated Ringers-6L Injection Replacement Electrolytes,
sterile, non-pyrogenic, packaged in a 6-liter bag, Rx.
Recall #V-010-5.
CODE Lot #940053 EXP 9/96.
MANUFACTURER DHL Laboratories, Inc., Union, South Carolina.
RECALLED BY Sanofi Animal Health, Inc., Overland Park, Kansas, by letter
November 14, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Colorado, California, Arizona, Iowa, Utah, Idaho, South
Dakota, Washington State.
QUANTITY 294 bags were distributed.
REASON Correctly-labeled bags of Lactated Ringers-6L were packed
into cases labeled as Multisol-R-6L.
SEIZURES:
=================================================================
_______________
PRODUCTS Canned Mud Skipper and Canned Mushrooms (94-725-953).
CHARGES Adulterated - One of the articles (the mushrooms) contains
an added poisonous and deleterious substance, staphylococcal
enterotoxin, which may render it injurious to health; and
both of the articles (the mushrooms and the mud skipper)
have been prepared and packed under conditions whereby they
may have been rendered injurious to health. Misbranded -
The labeling of one of the articles (the mushrooms) is false
and misleading because it represents and suggests that the
article was grown and packed in Taiwan, and that the article
is sliced mushrooms, which is contrary to fact.
LOCATION Tai Wing Hong Importer Inc., Brooklyn, New York.
FILED November 29, 1994; U.S. District Court, Eastern District of
New York; Civil #94-5466; FDC #67019.
SEIZED December 29, 1994 - goods valued at approximately $151,500.
_______________
PRODUCT ViroTM Glove Dermafilm, in-process and raw materials, and
accompanying labeling (over-the-counter drug promoted as an
antiseptic skin barrier useful in the prevention of
infection due to a broad spectrum of bacterial, fungal, and
viral disease-producing agents) (94-682-477).
CHARGES New drug - No approved new drug applications are in effect
for the articles. Adulterated - The methods used in, and
the facilities and controls used for, the articles'
manufacture, processing, packing, and holding do not conform
to and are not operated and administered in conformity with
current good manufacturing practice. Misbranded - The
articles fail to bear adequate directions for use, since
they are "new drugs" for which adequate directions cannot be
written.
-10- LOCATION Knight Industries, Inc., Pompano Beach, Florida.
FILED December 19, 1994; U.S. District Court for the Southern
District of Florida; Civil #94-7224-CIV-HURLEY; FDC #67000.
SEIZED December 27, 1994 - goods valued at approximately $100,000.
-11-
END OF ENFORCEMENT REPORT FOR JANUARY 25, 1995. BLANK PAGES MAY
FOLLOW.
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