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
05/22/1996

ENFORCEMENT REPORT FOR 05/22/1996

May 22, 1996 96-21

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Uneviscerated, smoked, vacuum packed herring.
Recall #F-542-6.
CODE None.
MANUFACTURER International Fish Company, Ltd., Etobicoke,
Ontario, Canada.
RECALLED BY Crown Eagle International Food, Inc.,
Brooklyn, New York (importer/distributor), by
letter on April 2, 1996. completed recall
resulted from sample analysis and followup by
the New York State Department of Agriculture
and Markets.
DISTRIBUTION New York, Massachusetts.
QUANTITY 278 units (13) cases were imported; firm
estimated that little or no product remained
on market at time of recall initiation.
REASON The product, uneviscerated, smoked, vacuum
packed herring, has the potential to support
the growth of Clostridium botulinum toxin.

_______________
PRODUCT Chocolate Candies: (a) Seashell Treasures
Hazelnut Cream Filled Belgian Chocolates,
125 g, 250 g, 500 g, and bulk;
(b) Dolce D'or Hedgehogs Pure Belgian
Chocolate, 224 g;
(c) Hazelnut Filled Chocolates, 250 gm under
Seashell Treasures and Seashells of Canada
labels. Recall #F-543/545-6.
CODE None.
MANUFACTURER Dynamic Chocolates, Inc., Richmond, British
Columbia, Canada.
RECALLED BY Manufacturer, by telephone followed by letter
dated February 9, 1996. Firm-initiated recall
complete.
DISTRIBUTION New York, New Jersey, California, Hawaii,
Canada.
QUANTITY Approximately 1,200 cases of hazelnut filled
chocolates were distributed.
REASON The product contains undeclared peanuts or
peanut products.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ==========
_______________
PRODUCT Sugar Palm in Syrup, in 12 ounce glass jars,
Phil Supreme brand. Recall #F-532-6.
CODE Not coded.
MANUFACTURER Fitrite, Inc., Kaloocan City, Philippines.
RECALLED BY Roger Santander Corporation, Jersey City, New
Jersey, by telephone on February 20, 1996.
Completed recall resulted from written
notification of the violative product from New
York State Department of Agriculture and
Markets.
DISTRIBUTION New Jersey.
QUANTITY 3 cases (24 units per case) were distributed;
Firm estimated none of the mislabeled product
remained on market at time of recall
initiation.
REASON Product contains undeclared FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Color blends manufactured from lot #142AD of
uncertified red dye (erythrosine):
(a) Butter Scotch E, Product #5020;
(b) Ice Cream Red 104-75640E, Product #7022;
(c) New Rose Pink Shade E 46%, Product #7240;
(d) Red Blend "RE", Product #52113.
Recall #F-527/530-6.

-2-CODE Lot numbers: (a) 1377R; (b) 1818R; (c) 2025R;
(d) 1993R, 1994R, 3074R.
MANUFACTURER Warner Jenkinson Company, Inc., St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on February 7,
1996. Firm-initiated recall complete.
DISTRIBUTION Michigan, California, Illinois, New York.
QUANTITY 2,860 pounds of the color blends were
distributed.
REASON Products were manufactured from an uncertified
lot of erythrosine.

_______________
PRODUCT Minute Maid Fruit Punch, in 64 ounce paper
cartons. Recall #F-531-6.
CODE Lot numbers: JUN10R, JUN11R, JUN14R.
MANUFACTURER Coca-Cola Foods, Paw Paw, Michigan; Coca-Cola
Foods, Plymouth, Florida.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visits
beginning April 30, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 17,294 cases (6 cartons per case) were
distributed.
REASON Product contains pear juice which is not
listed in the ingredient statement.

_______________
PRODUCT Hi-C fruit juice products in 8.45 fluid ounce
tetrapaks:
(a) Hi-C Fruit Punch
(b) Hi-C Ecto Cooler
(c) Hi-C Cherry
(d) Hi-C Boppin' Berry
(e) Hi-C Hula Punch
(f) Hi-C Grape
(g) Hi-C Orange Drink from concentrate
(h) Hi-C Double Fruit Cooler
(i) Hi-C Jammin Apple. Recall #F-533/541-6.
CODE (a) T30118A, T29541B, T30175D, T30176E,
T30176F, T30176G, T30179B, T30179C, T30183G
(b) T30181E; (c) T2954E, T29945F, T30143C,
T30164F, T30177A, T30177G, T30288D
(d) T29543D, T29944C, T29944D, T30173A,
T30173B, T30178A, T30178B; (e) T30146B
(f) T29544C, T29946E, T30180C
(g) T29540A, T29540B, T30182F, T30182G
(h) T29542C, T29943A, T30174B, T30174C,
T30184A; (i) T30187C.
MANUFACTURER Coca-Cola Foods, Paw Paw, Michigan.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visit
beginning on or about March 29, 1996. Firm-
initiated recall complete.
-3-DISTRIBUTION Nationwide.
QUANTITY 120,538 cases of 3 10-packs were distributed.
REASON Product lacks visible nutritional labeling
information.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Doxycycline Hyclate, Rx broad-spectrum
antibiotic in bottles of 50 and 500, under the
Lederle label: (a) Doxycycline Capsules, USP,
100 mg; (b) Doxycycline Tablets, 100 mg.
Recall #D-139/140-6.
CODE Control numbers: 388-112, 388-113, 388-114,
388-115, 378-166, 431-412, 431-413.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Danbury Pharmacal, Inc., Brewster, New York,
by letters on April 11 and 25 1996. Lederle
issued a subrecalling letter dated May 8,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY (a) 500's - 3,214 bottles to Lederle 5/20/94 &
12/16/94; 50's - 5,000 bottles to Lederle
12/13/94; (b) 500's - 6,849 bottles to Lederle
12/23/94 & 3/13/96; 50's - 10,000 bottles to
Lederle 12/23/94 and 3/13/96.
REASON Products distributed with non-current package
insert.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Calibration gases under the Scott and/or
Kontron labels:
(a) 4% Isoflurane, Balance Argon,
(b) 1% Isoflurane, 5% CO2, 65% N2O, 21% O2,
Balance N2
(c) 2% Isoflurane, 21% O2, Balance N2,
(d) 2% Isoflurane, Balance N2,
(e) 2% Enflurane, Balance N2.
Recall #Z-716/721-6.
CODE Lot numbers: (a) 120835, 092135, 012755;
(b) 070935, 072995; (c) 161665;
(d) 012515, 212545; (e) 252505, 312545;
(f) 032205, 081675.
MANUFACTURER Scott Specialty Gases, Inc., Scott Medical
Products Division, Plumsteadville,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated February 5,
1996, followed by telephone. Firm-initiated
recall ongoing.
DISTRIBUTION Colorado, New Jersey, Virginia, Sweden,
England.
-4-QUANTITY 633 units were distributed.
REASON Devices do not meet their concentration
specifications as stated on the labeling
because of a defect in a certain sealing
gasket.

_______________
PRODUCT Multitask Operating System Version 2.30 'D'
Software for use with the Clintec Automix 3+3
Compounder System. The software aids the
pharmacist in tasks associated with the
compounding of nutritional support solutions.
Recall #Z-747-6.
CODE Product #2M8291, Software Version 2.30 'D'.
MANUFACTURER CompDisk, Morton Grove, Illinois.
RECALLED BY Clintec Nutrition Company, affiliated w/Baxter
Healthcare & Nestle SA, Deerfield, Illinois,
by telephone on April 12, 13, 14, 1996,
followed by letter dated April 15, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 658 software units were distributed.
REASON A software bug in the Automatic Additive
Selector option may result in dispensing an
inaccurate measure of electrolytes.

_______________
PRODUCT Image Amplification Surgical Table Model
2080 I.A. Recall #Z-758-6.
CODE Model 2080 I.A. tables, manufactured between
January 1983 and November 1988, with serial
numbers falling in the range of 0423183-022
through but not including 0432388-100. These
serial numbers are NOT inclusive since other
models of surgical tables were manufactured
during the time frame with serial numbers
which fall into this range.
MANUFACTURER AMSCO American Sterilizer Company, Montgomery,
Alabama.
RECALLED BY AMSCO American Sterilizer Company, Erie,
Pennsylvania, by mailing a "Safety
Notification" dated January 6, 1989. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,395 tables were distributed.
REASON There is a tipping hazard when positioning
obese patients in the reverse orientation.

_______________
PRODUCT (a) PLV-100 Ventilators; (b) PLV-102
Ventilators. Recall #Z-759/760-6.

-5-CODE (a) All units which contain an alarm harness
block from Lots 36030D5 and 36030E5 (Lifecare
part number 35895)
(b) All units which contain an alarm harness
block from Lots 36030D5 and 36030E5 (Lifecare
part number 35895).
MANUFACTURER Lifecare International, Inc., Westminster,
Colorado.
RECALLED BY Manufacturer, by letter March 27, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 72 units; (b) 80 units were distributed.
REASON There is a potential for alarm malfunction
and/or unit shutdown with no alarm.

_______________
PRODUCT Sperti brand Sunlamp, Model P-164-RT, Riviera
(Table Model), used for skin tanning.
Recall #Z-766-6.
CODE Code #AP164RT27 manufactured on March 6 and 7,
1996.
MANUFACTURER Time Teck, Whitewater, Wisconsin (component
supplier/responsible firm).
RECALLED BY KBD, Inc., Erlanger, Kentucky, by telephone
and by letter mailed on April 9, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Illinois, Arizona, Oregon, Colorado, Florida,
Nevada, Maryland.
QUANTITY 38 units were distributed.
REASON The nut, which secures the timer to the shell
of the sunlamp, can break the plastic timer
casing when it is tightened. This causes the
timer control shaft to become detached and it
falls into the timer case. The timer nut
tightens when the timer knob is turned to set
the timer mechanism. The breakage occurs
before electrical contact is made and the unit
never operates.

_______________
PRODUCT UBM Model 840 Scanhead Joint Assembly,
Ophthalmic Ultrasound System.
Recall #Z-788-6.
CODE Serial numbers: 840-1149, 840-1133, 840-1127,
840-1105, 840-1056, 840-1045,840-1113,
840-1040, 840-1136, 840-1117, 840-1039,
840-1018, 840-1135, 840-1147,
840-1150,840-1146, 840-1144, 840-1143,
840-1038, 840-1005, 840-1037, 840-1023,
840-1030.
MANUFACTURER Humphery Instruments, Inc., a division of Carl
Zeiss, Inc., San Leandro, California.

-6-RECALLED BY Carl Zeiss, Inc., Thornwood, New York, by
mailing a Customer Acknowledgement Form on
January 17-19, 1996. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 34 units were distributed.
REASON The system's scanhead may drop on a patient
because of metal fatigue at the device's
scanhead joint assembly.

_______________
PRODUCT Equipment Manuals for AMSCO 3080 RL/SP
Surgical Table. Recall #Z-789-6.
CODE The incorrect equipment were shipped with
surgical tables bearing serial numbers between
B420493011 through B431894061, inclusive,
which were distributed between July 1993 and
November 1994. THE SURGICAL TABLES ARE NOT
SUBJECT TO THIS ACTION.
MANUFACTURER AMSCO American Sterilizer Company, Montgomery,
Alabama (tables).
RECALLED BY AMSCO American Sterilizer Company, Erie,
Pennsylvania, by letter on August 10, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,901 tables were distributed.
REASON The manuals specify an erroneous patient
weight limitation of 500 pounds instead of 400
pounds.

_______________
PRODUCT Sterile E-Z Clean Cautery Tip, Catalog #0012,
an electrode used in electrosurgical pencils.
Recall #Z-790-6.
CODE Lot #2183.
MANUFACTURER MegaDyne Medical Products, Inc., Draper, Utah.
RECALLED BY Manufacturer, by fax on April 3, 1996,
followed by letter on April 4, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Japan, Italy.
QUANTITY Approximately 190,000 units were distributed;
firm estimated that a majority of the product
had already been used at time of recall
initiation.
REASON The sterility of the device has been
compromised due to loss of package integrity.

-7-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Stratus Brand CK-MB Fluorometric Enzyme
Immunoassay, a rapid and sensitive automated
procedure for the quantitative determination
of CK-MB in human serum. Recall #Z-728-6.
CODE Lot No. CKMB-2727, EXP June 5, 1996, Catalog
No. B5700-60.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by telephone on January 26-29,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 116 kits were distributed.
REASON The above lot of material may have units which
do not contain Dulbecco's Phosphate Buffered
Saline but contain water.

_______________
PRODUCT Inhibitory Mold Agar Media Plates, Catalog
#01-505, an in-vitro diagnostic packaged 10
plates per box. Recall #Z-767-6.
CODE Lot #5513 EXP 8/25/95.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on August 2, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,710 units were distributed; firm estimates
none remains on the market.
REASON The plates inside the box were labeled as BHI
(Blood Heart Infusion) Agar, but the box was
labeled as Inhibitory Mold Agar (IMA).

_______________
PRODUCT Bactidrop Spot Indole, Catalog #21-550, a
reagent used to determine the ability of an
organism to split indole from the tryptophan
molecule, packaged 50 - .75 ml ampules per
box. Recall #Z-768-6.
CODE Lot #5501 EXP 5/31/97.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on June 5-6, 1995.
Firm-initiated recall complete.
DISTRIBUTION Georgia, Florida, Virginia, Connecticut,
Wisconsin, Oklahoma, Kansas, California,
Alaska, New Jersey, Pennsylvania, Missouri.
QUANTITY 203 boxes were distributed; firm estimates
none remains on the market.
REASON The device did not give the expected blue
color reaction, because ampule contained
Kovac's Indole Reagent instead of Spot Indole.

-8-_______________
PRODUCT MRL Yellow Agar (Double Pour) Media Plates,
Catalog #01-543, an in-vitro diagnostic,
packaged 10 units per box. Recall #Z-771-6.
CODE Lot #5521 EXP 2/29/96.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on December 28,
1995. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 40 units were distributed; firm estimates none
remains on the market.
REASON Several packages labeled MRL Yellow Agar
contained D'NASE test Agar.

_______________
PRODUCT MRL RED (Double Pour) plates, Catalog #01-541,
an in-vitro diagnostic, packaged 10 plates per
box. Recall #Z-772-6.
CODE Lot #5520 EXP 12/22/95.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on November 13,
1995. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 140 units were distributed; firm estimates
none remains on the market.
REASON The packages labeled as MRL RED contained MRL
Green.

_______________
PRODUCT Brain Heart Infusion (BHI) Agar with Blood
with Chloramphenicol with Gentamicin, Media
Plates, Catalog #10-248, an in-vitro
diagnostic. Recall #Z-778-6.
CODE Lot #5507 EXP 12/31/95.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on August 17, 1995.
Firm-initiated recall complete.
DISTRIBUTION Illinois, California, Utah.
QUANTITY 140 units were distributed; firm estimates
none remains on the market.
REASON The individual plates were labeled as "BHI
with Blood" instead of "BHI with Blood with
Chloramphenicol with Gentamicin." The outer
box was correctly labeled as "BHI with Blood
with Chloramphenicol with Gentamicin."

-9-

END OF ENFORCEMENT REPORT FOR MAY 22, 1996. BLANK PAGES MAY FOLLOW.

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