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.

November 20, 1996 96-47

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Deering brand ice cream, in 3-gallon tubs:
(a) French Vanilla Ice Cream
(b) French Chocolate Chip Ice Cream
(c) French Cookies'N Cream Ice Cream
(d) Pistachio Ice Cream. Recall #F-048/051-7.
CODE All misbranded product.
MANUFACTURER Down East Frozen Desserts, LLC, doing business
as Deering Ice Cream, Portland, Maine.
RECALLED BY Manufacturer, by letter/flyers on September
16, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Maine, Massachusetts, Connecticut.
QUANTITY Undetermined.
REASON Products do not bear ingredient statements and
contain allergens as follows: (a) egg yolks;
(b) egg yolks; (c) egg yolks and wheat flour;
(d) cashews, pistachios, and FD&C Yellow
No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Sunbeam Popcorn (pre-popped and seasoned
popcorn), in 2-1/2 peck and 6 peck clear
plastic bags. Recall #F-042-7.
CODE All lots.
MANUFACTURER Sunbeam Snacks & Paper Company, Dallas, Texas.
RECALLED BY Manufacturer, by visit and by letter mailed
September 23-25, 1996. Firm-initiated field
correction (relabeling) ongoing.
DISTRIBUTION Texas.
QUANTITY Firm estimated that 30 bags remained on market
at time of recall initiation.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Deering brand ice cream, sherbet, sorbet, and
fat free yogurt products, in 3-gallon tubs:
(a) Mississippi Mud Ice Cream
(b) Heath Bar Ice Cream
(c) Chocolate Peanut Butter Cookie Dough Ice
Cream
(d) Coffee Ice Cream
(e) Mint Chocolate Chip Ice Cream
(f) Coffee Fudge Ice Cream
(g) Lemon Chill Ice Cream
(h) Lemon Sherbet
(i) Sherbet Bouquet
(j) Lemon Sorbet
(k) Mocha Fudge Fat Free Yogurt.
Recall #F-052/062-7.
CODE All misbranded product.
MANUFACTURER Down East Frozen Desserts, LLC, doing business
as Deering Ice Cream, Portland, Maine.
RECALLED BY Manufacturer, by letter/flyers on September
16, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Maine, Massachusetts, Connecticut.
QUANTITY Undetermined.
REASON Products do not bear ingredient statements and
contain allergens as follows: (a) wheat
flour, almonds, and FD&C Yellow No. 5; (b)
almonds; (c) wheat flour (the peanut component
of this product poses a remote hazard to
health since a consumer sensitive to peanuts
is expected to avoid this product based on its
identity alone); (d) - (k) FD&C Yellow No. 5.

_______________
PRODUCT Texas Gourmet Pickles in 16 fluid ounce glass
jars. Product is also private-labeled for New
Braunfels Smokehouse. Recall #F-070-7.
CODE All codes ending in 6: A6, B6, C6, D6, E6,
F6, G6, H6, J6.
MANUFACTURER Picolo Pickle Company, Corsicana, Texas.
RECALLED BY Manufacturer, by letter, and by telephone on
September 12, 1996. Firm-initiated recall
ongoing.

-2-DISTRIBUTION Texas, Tennessee, Oklahoma, Arkansas,
Illinois.
QUANTITY firm estimated that 10,500 units remained on
market at time of recall initiation.
REASON Product contains undeclared color additives
(FD&C Yellow No. 5 and Blue No. 1).

_______________
PRODUCT Prune Juice from concentrate, in 46 ounce
cans, under the following labels: Sunbright,
Nugget, Nifda. Recall #F-072-7.
CODE SUHJ6/RNA11.
MANUFACTURER Silver Springs Citrus, Howey-in-the-Hills,
Florida.
RECALLED BY Manufacturer, by fax followed by telephone on
October 31, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Alabama, Indiana, Georgia, Kentucky,
Louisiana, North Carolina, Maryland, Virginia,
Ohio.
QUANTITY 846 cases of all labels were distributed.
REASON Product contains lead in excess of the level
of concern of 80 parts per billion.

_______________
PRODUCT Prune Juice from concentrate, in 4 ounce
plastic single serve containers.
Recall #F-073-7.
CODE Lot #233 0501 B on the cases.
MANUFACTURER M&B Dairy Products, Tampa, Florida.
RECALLED BY Manufacturer, by telephone on September 23,
1996, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, Georgia.
QUANTITY 1,786 cases were distributed.
REASON Product contains lead in excess of the level
of concern of 80 parts per billion.

_______________
PRODUCT Ceramic Mugs, "Garden Fresh" Tableware
Pattern: (a) Carrot Design Mug; (b) Corn
Design Mug; (c) Peas Design Mug; (d) Radish
Design Mug. Recall #F-074/077-7.
CODE "GARDEN FRESH MUG TABLETOPS UNLIMITED MADE
IN CHINA" is printed on stickers affixed to
the bottom of the mugs.
MANUFACTURER Imported from China.
RECALLED BY Dollar General Corporation, Scottsville,
Kentucky, by letter dated September 20, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 30,144 mugs were distributed.

-3-REASON The mugs contain excessive levels of leachable
lead.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Mott's Variety Pack Applesauce, 18 single
serve cups: 6 4-ounce Original Applesauce
cups; 6 4-ounce Cinnamon Applesauce Cups; 6
3.9-ounce Raspberry Applesauce cups.
Recall #F-045-7.
CODE 21144.
MANUFACTURER Motts, Inc., Williamstown, New York.
RECALLED BY Mott's, Inc., Stamford, Connecticut, by letter
on October 4, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 40,760 cases were distributed.
REASON The outer labeling "sell sheet" of the product
does not declare FD&C Red 40 and FD&C Blue 1
as ingredients of the raspberry applesauce
variety. The individual cups and 3-cup sleeve
are labeled correctly.

_______________
PRODUCT Deering brand ice cream in 3-gallon tubs:
(a) Swiss Chocolate Almond Ice Cream
(b) Maple Walnut Ice Cream
(c) Butter Pecan Ice Cream
(d) Praline Pecan Ice Cream
(e) Chocolate Almond Fudge Ice Cream
(f) Chocolate Peanut Butter Fudge Ice Cream
(g) Almond Joy Ice Cream.
Recall #F-063/069-7.
CODE All misbranded product.
MANUFACTURER Down East Frozen Desserts, LLC, doing business
as Deering Ice Cream, Portland, Maine.
RECALLED BY Manufacturer, by letter/flyers on September
16, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Maine, Massachusetts, Connecticut.
QUANTITY Undetermined.
REASON Products are misbranded in that they do not
bear an ingredient statement. They, however,
pose a remote hazard to health since the
allergen (nuts) is listed in the product's
identity and a consumer sensitive to that
allergen would avoid the product based on its
identity alone.

-4-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Pseudoephedrine HCl, adrenergic bulk
pharmaceutical, non-Rx, under the following
labels: China Meheco Zhuhai Import & Export
Company, Buckton Scott Limited, and H. Reisman
Corporation. Recall #D-035-7.
CODE Lot numbers: 940501 (Buckton Scott), PSE-
02501 (H. Reisman).
MANUFACTURER China Meheco Zhuhai Import & Export Company,
China (bulk manufacturer).
RECALLED BY H. Reisman Corporation, Orange, New Jersey
(importer), by telephone May 24, 1995 followed
by letter via fax. Firm-initiated recall
complete.
DISTRIBUTION Michigan, Texas.
QUANTITY 145 kg were distributed; firm estimated that
10 percent of product remained on market at
time of recall initiation.
REASON Pseudoephedrine HCl was mistakenly mixed with
Ephedrine HCl.

_______________
PRODUCT Nature's Formula Herbal Espresso, in 1 fluid
ounce/30 ml plastic bottles, dietary
supplement. Recall #D-036-7.
CODE All lots distributed prior to August 30, 1996.
MANUFACTURER EFS-Herbal Drops, San Diego, California.
RECALLED BY Manufacturer, by letter sent September 18-20,
1996. Firm-initiated recall complete.
DISTRIBUTION Arizona, Arkansas, California, Florida,
Louisiana, Minnesota, Mississippi, Nevada,
Oklahoma, Tennessee, Texas, Utah, Washington
state, Wisconsin, Canada.
QUANTITY Approximately 3,609 bottles were distributed.
REASON Unapproved new drug; product labeled for use
as a bronchodilator.

_______________
PRODUCT UDL Laboratories brand Amantadine HCl
Capsules, USP, 100 mg, unit dose packaged in
blister pack strips of 10, Rx indicated in the
treatment of idiopathic Parkinson's disease.
Recall #D-037-7.
CODE Lot #5V850 EXP 6/97.
MANUFACTURER Banner Pharmacaps formerly known as Chase
Laboratories, Inc., Newark, New Jersey
(responsible firm).
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois
(repacker), by letter dated October 30, 1996.
Firm-initiated recall ongoing.

-5-DISTRIBUTION Nationwide.
QUANTITY 2,093 unit cartons were distributed; firm
estimated that 20 percent of product remained
on market at time of recall initiation.
REASON Dissolution failure at 9-month stability
timepoint.

_______________
PRODUCT Minocycline Hydrochloride Capsules, USP, 50
mg, in bottles of 100. Recall #D-038-7.
CODE Lot #11415L EXP 1/97.
MANUFACTURER Warner-Lambert Company, Lititz, Pennsylvania
(responsible firm).
RECALLED BY Warner Chilcott, Inc., Morris Plains, New
Jersey, by letter dated October 18, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,767 bottles were distributed.
REASON Lot failed content uniformity test (one
capsule was less than 67%LS, RSD of 10 is
13%).

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Servo O2 Oxygen Control System, used to
provide precise control of oxygen
concentration for infants in the Care Plus
Incubator or under oxygen hoods.
Recall #Z-134-7.
CODE Part #6600-0236-901. All serial numbers.
MANUFACTURER BPR Medical Systems, Mansfield, Notts, United
Kingdom.
RECALLED BY Ohmeda, Specialty Products Division, Columbia,
Maryland, by letter dated October 14, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Tennessee, California.
QUANTITY 33 units were distributed.
REASON The low battery audible alarm may not sound
prior to battery depletion and subsequent
device shutdown, and the nominal time of
operation remaining after activation of the
visual low battery alarm is seven minutes
rather than the specified nominal value of ten
minutes.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Coulter MD Automated Hematology Analyzers, for
in-vitro diagnostic testing:

-6- (a) MD 8, Model No. 0076;
(b) MD 10, Model No. 0083;
(c) MD 16 with Histogram, Model No. 0074;
(d) MD 16 without Histogram, Model No. 0084;
(e) MD 18 with Histogram, Model No. 0944;
(f) MD 18 without Histogram, Model No. 0945.
Recall #Z-090/095-7.
CODE Serial Numbers: All units with serial numbers
below V50759, serial number W0500252 or below
and all serial numbers below R940502.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on February 18, 1994.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 1,353 units were distributed.
REASON The models with software version 1F1 or lower
could report erroneous platelet results on
specimens that exceed the linearity range.

_______________
PRODUCT Coulter ONYX Automated Differential Cell
Counters, Part #6705522, Model numbers: 0690
and 0692. Recall #Z-096-7.
CODE Serial numbers: V35116, V351123, V35124,
V35127, V35128, V35137, V35138, V35141,
V35142, V35144, V35145, V35148, V35150,
V35151, V35152, V35153, V40157, V40158,
V40162, V40165, V40176, V40170, V40172,
V40173, V40174, V40175, W04002, W04003,
W04004, W04008, W04016, W04017, W04018,
W04019, W04023.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on February 15, 1994.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 38 units were distributed.
REASON Software program Level 1.0 could report an
erroneous platelet result on specimens that
exceed the linearity range.

_______________
PRODUCT Coulter MAXM and MAXM with Autoloader, used as
a automated hematology cell counters and
differential cell counter for in-vitro
diagnostic use: (a) MAXM, Model 0041;
(b) MAXM with Autoloader, Model 0056.
Recall #Z-097/098-7.
CODE Serial numbers: P1001 to P1032 and T15001 to
W04031, and serial numbers below W0300173.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on April 26, 1994.
Firm-initiated field correction complete.
-7-DISTRIBUTION Nationwide.
QUANTITY 953 units were distributed.
REASON Software failure could report an erroneous
platelet result.

_______________
PRODUCT Coulter MAXM Cell Counters, automated
hematology cell counters and differential cell
counter for in-vitro diagnostic use:
(a) MAXM, Model No. 0041
(b) MAXM with Retic, Model No. 0056
(c) MAXM with Autoloader, Model No. 0141
(d) MAXM with Autoloader Retic, Model No.
0156. Recall #Z-099/102-7.
CODE Serial numbers: (a) U43370 to W05041 &
R930704 to R934709; (b) U43370 to W05041 &
R930704 to R934709; (c) U43001 to W06049,
R9400702, V1000618 to W1000527; (d) U43001 to
W06049, R9400702, V1000618 to W1000527.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on June 15, 1994.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 524 units were distributed.
REASON The reagent can run out without giving
warning, caused by a capacitor that has the
polarity reversed.

_______________
PRODUCT Coulter Automated Differential Cell Counters:
(a) COULTER S550; (b) COULTER S560;
(c) COULTER S770; (d) COULTER S790;
(e) COULTER S7120; (F) COULTER S880;
(g) COULTER S880 MICRO;
(h) COULTER JR, JR with IR and JS;
(i) COULTER ST; (j) COULTER STKR;
(k) COULTER STKS; (l) COULTER S-PLUS I;
(m) COULTER S-PLUS II;
(n) COULTER S-PLUS III;
(o) COULTER S-PLUS IV, S-PLUS IV with/ DIFF;
(p) COULTER S-PLUS V; (q) COULTER S-PLUS VI;
Recall #Z-103/119-7.
CODE All serial numbers.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on January 19, 1995.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 6,187 units were distributed.
REASON The diluent pickup tube assembly may not
ensure sufficient diluent levels when the low
level alarm is triggered.

-8-_______________
PRODUCT Automated Differential Cell Counters
manufactured and marketed by Coulter under the
names Coulter ONXY Model Number 0692.
Recall #Z-120-7.
CODE Serial numbers: W26474 and W22418.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on November 28, 1994.
Firm-initiated field correction complete.
DISTRIBUTION Illinois.
QUANTITY 2 units were distributed.
REASON Certain analog boards produced an elevated
frequency of aperture error #16 during control
recovery.

_______________
PRODUCT COULTER ONYX Automated Differential Cell
Counters:
(a) ONYX Monochrome, Model No. 0690
(b) ONYX w/Autoloader, Model No. 0691
(c) ONYX Color, Model No. 0692
(d) ONYX w/Autoloader/Color, Model No. 0693.
Recall #Z-121/124-7.
CODE Serial numbers (a) V22390 - Y17150
(b) V22406 - Y17150
(c) V22390 - Y17150 & Y0300137 & above
(d) V22406 - Y05020 & Y0600262 & above.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on July 7, 1995.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 701 units were distributed.
REASON Product may dilute patient samples in the
closed vial mode when the needle vent line
becomes obstructed.

_______________
PRODUCT Coulter MD ONXY Automated Differential Cell
Counters:
(a) ONYX, Model No. 0690
(b) ONYX with Autoloader, Model No. 0691
(c) ONYX & ONYX with autoloader made in UK,
Model Nos. 0692 & 0693. Recall #Z-125/127-7.
CODE Serial numbers: (a) V22390 - Y48350;
(b) W22406 - Y48350;
(c) W2901362 - Y4502138.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on November 20, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 786 units were distributed.

-9-REASON Software errors can cause misidentification of
patient results and/or incorrect transmission
of specific default values for eosinophil and
basophil.

_______________
PRODUCT Coulter Cytotrol Control Cells, Part #6604248,
reagent used to assess the activity of
monoclonal antibodies by flow cytometry.
Recall #Z-128-7.
CODE Lot #731901K EXP 6/27/96.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on December 7, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 90 kits were distributed.
REASON An increase of RBC debris was found in the
control cells which can lead to an inability
to achieve Expressed Assay Values.

_______________
PRODUCT 4C Plus Coulter Counter Cell Control, Part
#7546844, used for monitoring the precision of
Coulter instruments. Recall #Z-129-7.
CODE Kit Lot #27019K, Vial Lot #443100 EXP 5/20/96.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on May 6, 1996. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 61 kits were distributed.
REASON Low RDW recovery for abnormal high 4C Plus
Cell Control can be obtained.

_______________
PRODUCT SPORTROL Growth Promotion Test Suspensions,
containing Clostridium sporogenes, 10 ml of
suspension distributed in plastic vials, one
(1) vial per package, for USP growth promotion
testing. Recall #Z-130-7.
CODE Catalog #GP-02, Lot #GCS003-19.
MANUFACTURER North American Science Associates, Inc.,
NAmSA), Northwood, Ohio.
RECALLED BY Manufacturer, by telephone beginning on
October 29, 1996, followed by letter. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Ireland, Singapore, Japan.
QUANTITY 53 vials were distributed.
REASON There was reduction in the spore population
counts below the labeled range.

END OF ENFORCEMENT FOR NOVEMBER 20, 1996. BLANK PAGES MAY
FOLLOW.

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End of Enforcement Report for