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
11/23/1994
Recalls and Field Corrections: Foods -- Class I -- 11/23/1994
November 23, 1994 94-47
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Ice cream, frozen yogurt, frozen dessert, in 3 gallon bulk
containers: (a) Tin Roof Ice Cream; (b) Candy Bar Frozen
Yogurt; (c) Tofutti brand Chocolate Cookies Supreme Frozen
Dessert. Recall #F-097/099-5.
CODE All product manufactured since April 1, 1994.
MANUFACTURER Kemp's Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letters of September 2 and 8, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, New York, Maryland,
Virginia, Connecticut.
QUANTITY Firm estimates very little if any product remains on the
market.
REASON Products contain undeclared peanuts.
_______________
PRODUCT Various flavored ice cream in 3 gallon bulk containers:
(a) Chocolate Lover's Chocolate; (b) Pralines'N' Cream.
Recall #F-100/101-5.
CODE All product manufactured between March 1, 1994 and September
1, 1994.
MANUFACTURER Kemp's Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letters of September 2 and 8, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, New York, Maryland,
Virginia, Connecticut.
QUANTITY Firm estimates very little if any product remains on the
market.
REASON Products contain undeclared pecans.
_______________
PRODUCT Various flavored ice cream in 3 gallon bulk containers:
(a) French Vanilla Ice Cream; (b) French Custard Ice Cream;
(c) German Chocolate Ice Cream Frozen Dessert.
Recall #F-102/104-5.
CODE All codes Manufactured since April 1, 1994.
MANUFACTURER Kemp's Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letters of September 2 and 8, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, New York, Maryland,
Virginia, Connecticut.
QUANTITY Firm estimates very little if any product remains on the
market.
REASON Products contain undeclared eggs.
_______________
PRODUCT Dudek Foods brand Potato Pancakes, in 1 pound plastic bags.
Recall #F-105-5.
CODE All codes.
MANUFACTURER Dudek Foods, Inc., Hamtramck, Michigan.
RECALLED BY Manufacturer, by press release issued September 29, 1994,
and by telephone beginning September 30, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Michigan, Ohio, Indiana.
QUANTITY Firm estimated that 300 one-pound units remained on the
market at the time recall was initiated.
REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Various flavored ice cream and frozen desserts packaged in 3
gallon containers: (a) Butter Pecan Ice Cream;
(b) Caramel Butter Pecan Ice Cream;
(c) Tofutti brand Butter Pecan Frozen Dessert.
Recall #F-088/090-5.
CODE All codes manufactured in the last 6 months.
MANUFACTURER Kemp's Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letters of September 2 and 8, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, New York, Maryland,
Virginia, Connecticut.
QUANTITY Firm estimates very little if any product remains on the
market.
REASON Product contains undeclared pecans.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT (a) Hydroxyzine Pamoate Capsules, USP, 25 mg, in bottles of
100, Rx drug indicated for treatment of anxiety; under the
Schein label; (b) Timolol Maleate Tablets, USP, 10 mg, in
bottles of 100, Rx drug for treatment of hypertension, under
the Schein label. Recall #D-029/030-5.
CODE Lot #10883C EXP 3/96.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Danbury Pharmacal, Inc., Brewster, New York, by letters of
September 23, 1994, and October 6, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 23,503 bottles; (b) 4,268 bottles were distributed; firm
estimated that 3,525 bottles of Hydroxyzine and 1,400
bottles of Timolol Maleate remained on the market at time
the recall the was initiated.
REASON A bottle of Timolol Tablets 10 mg was found mislabeled as
Hydroxyzine Capsules 25 mg.
_______________
PRODUCT Allergan Lacril Lubricant Ophthalmic Solution, in 15 ml
plastic containers, indicated for use as a lubricant to
prevent irritation or relieve dryness of the eye.
Recall #D-031-5.
CODE Lot numbers: 660T EXP 9/94, 4277U EXP 2/95, 4278U EXP 7/95,
4279U EXP 11/95, 4273X EXP 1/96, 4274X EXP 4/96.
MANUFACTURER Allergan America, Hormigueros, Puerto Rico.
RECALLED BY Allergan, Inc., Irvine, California, by letter August 29,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 256,757 individual units were distributed from February 1993
through July 1994; firm estimated that 50,000 units remained
on the market at the time the recall was initiated.
REASON Product does not meet preservative effectiveness test.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-022-5.
CODE Unit #15KL05107.
MANUFACTURER The American National Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by letter February 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Montana.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who reported a history
of cancer, was distributed for transfusion.
-3- _______________
PRODUCT Rho(D) Immune Globulin (Human), in single dose syringes and
vials, a sterile immunoglobulin solution containing Rho(D)
antibodies for intramuscular use: (a) Gamulin Rh; (b) Mini-
Gamulin Rh. Recall #B-041/042-5.
CODE Lot numbers: (a) J23809, J23910, J24010, J24110, J24211,
J24311, J2909, J3010, L24402, L24502, L24603, L24705,
L24805, L24905, L25006, L25106, L25307, L25609, L3104,
L3205, L3310, L3410; (b) J25511, L25604, J5610, J5711,
L5803.
MANUFACTURER Armour Pharmaceutical Company, Kankakee, Illinois.
RECALLED BY Manufacturer, by letter August 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 262,458 syringes and 76,260 vials; (b) 38,448 syringes
and 47,885 vials were distributed.
REASON Rh(D) immune globulin demonstrating a loss of potency was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-062/064-5.
CODE Unit #20H10941.
MANUFACTURER The American National Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, (a&b) by letter November 16, 1993; (c) by fax
November 18, 1993. Firm-initiated recall complete.
DISTRIBUTION (a&b) Idaho; (c) California.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who reported
previously testing positive for hepatitis, were distributed.
_______________
PRODUCT Summit Sample Handling System, a micropipettor designed to
support the Ortho Microwell ELISA Test System.
Recall #B-065-5.
CODE All serial numbers.
MANUFACTURER Hamilton Bonaduz AG, Bonaduz, Switzerland.
RECALLED BY Ortho Diagnostic Systems, Inc., Raritan, New Jersey, by
letters of December 22, 1993, January 21, 1994, and May 3,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 238 units.
REASON Micropipettors, that may improperly eject test samples, were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-066/067-5.
CODE Unit #4436277.
MANUFACTURER Sarasota Community Blood Bank, Sarasota, Florida.
RECALLED BY Manufacturer, by letter April 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida.
-4- QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who
admitted to traveling to areas designated as endemic for
malaria, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets Pheresis.
Recall #B-068/069-5.
CODE Unit numbers: (a) 3113659; (b) 1234754, 1234911.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
RECALLED BY Manufacturer, by letter June 30, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products, which were collected from a donor who had
visited an area designated as endemic for malaria, were
distributed.
_______________
PRODUCT Anti-Jkb Blood Grouping Reagent. Recall #B-070-5.
CODE Lot #JKB17A.
MANUFACTURER Ortho Diagnostics Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter June 13, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 274 units.
REASON Anti-Jkb Blood Grouping Reagent, which contained anti-E
antibodies, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-071-5.
CODE Unit numbers: 2X7335, 9Z9397, 7P8033.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone January 24, 1994. Firm-initiated
recall complete.
DISTRIBUTION Washington State.
QUANTITY 3 units.
REASON Blood products, which were incorrectly labeled as "CPDA-1
Red Blood Cells - Leuko-Poor by Filtration," were
distributed.
_______________
PRODUCT Platelets Pheresis. Recall #B-072-5.
CODE Unit #24FL23527.
MANUFACTURER American National Red Cross (The), Louisville, Kentucky.
RECALLED BY Manufacturer, by telephone and by letter March 18, 1994.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.
-5- _______________
PRODUCT Red Blood Cells. Recall #B-073-5.
CODE Unit numbers: 12GM15789 and 12GN11299.
MANUFACTURER American National Red Cross (The), Charlotte, North
Carolina.
RECALLED BY Manufacturer, by telephone March 18, 1994, followed by
letter March 21, 1994. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed for transfusion.
_______________
PRODUCT Red Blood Cells. Recall #B-075-5.
CODE Unit #1854774.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter September 23, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had traveled to an
area designated as endemic for malaria, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-023-5.
CODE Unit #15KL05107.
MANUFACTURER The American National Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by fax February 8, 1994. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who reported a history
of cancer, was distributed for further manufacture into
injectable products.
_______________
PRODUCT Red Blood Cells. Recall #B-044-5.
CODE Unit #562622.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone February 14, 1994. Firm-
initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-060-5.
CODE Unit #24LZ31272.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
-6- RECALLED BY Manufacturer, by fax April 7, 1994. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, collected from an ineligible donor due to a
reported history of cancer, was distributed.
_______________
PRODUCT Platelet. Recall #B-061-5.
CODE Unit numbers: 764199, 764201, 764216, 764289, 764316,
764387.
MANUFACTURER Blood Systems, Inc., (doing business as) United Blood
Services, Billings, Montana.
RECALLED BY Manufacturer, by letter April 1, 1991. Firm-initiated
recall complete.
DISTRIBUTION Montana, Wyoming.
QUANTITY 6 units.
REASON Blood products, which tested negative for the antibody to
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-074-5.
CODE Unit numbers: 12GM15789 and 12GN11299.
MANUFACTURER American National Red Cross (The), Charlotte, North
Carolina.
RECALLED BY Manufacturer, by fax March 23, 1994. Firm-initiated recall
complete.
DISTRIBUTION California, Switzerland.
QUANTITY 2 units.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed for further
manufacture.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Sims Deltec brand CADD-Micro, Ambulatory Infusion Pump,
Model 5900, provides measured drug therapy to patients in
hospital or outpatient settings. Recall Z-072-5.
CODE Reorder #21-5900, serial number range: 510042-510445.
MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter January 10, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, England, Germany, Canada.
QUANTITY 170 pumps were distributed.
REASON A software error in this device, under specific conditions,
will cause the CADD-Micro Pump to stop, clear all
programming parameters to zero and default to lock level 2.
-7- _______________
PRODUCT Spand-Gel Wound Absorption Gel, in 60 cc syringes and 4
ounce tubes, used for Stage I, II, III and particularly
State IV full thickness dermal ulcers, diabetic foot ulcers,
peripheral vascular disease ulcers, venous stasis ulcers,
and incision breakdown, first and second degree burns.
Recall #Z-092-5.
CODE All lots.
MANUFACTURER Phoenix Cosmetics Laboratories, Inc., Holbrook, New York.
RECALLED BY Medi-Tech International, Brooklyn, New York, by letter on or
about October 10, 1994, followed by telephone. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,054 tubes and 3,648 syringes were distributed.
REASON The device was found to have been distributed non-sterile.
_______________
PRODUCT Portex Remote Injection Catheter, sterile product used
during anesthesia. Recall #Z-100-5.
CODE Catalog #240001, lot #405443.
MANUFACTURER Smiths Industries Medical Systems, Inc., Keene, New
Hampshire.
RECALLED BY Manufacturer, by telephone July 29, 1994, followed by letter
August 3, 1994. Firm-initiated recall complete.
DISTRIBUTION Missouri, Illinois.
QUANTITY 42 boxes (10 units per box) were distributed.
REASON The primary sterile package for the device is absent, thus
the Remote Injections Catheter was not packaged in the tyvek
pouch and the sterility of the unit compromised.
_______________
PRODUCT American Dental Laser dLase 300 Dental ND:YAG Laser System.
(The training manual, which references the dLase 300 is
under recall). Recall #Z-103-5.
CODE All units.
MANUFACTURER Sunrise Technologies, Fremont, California.
RECALLED BY Institute for Laser Dentistry, Inc., Troy, Michigan, by on
or about July 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY An estimate of over 2,000 manuals were distributed.
REASON Manual included instructions for performing unapproved
procedures in the dLase 300 Training manual.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Promotional material and labeling accompanying Cervitrac
Chiropractic Machine, used for massaging the neck.
Recall #Z-078-5.
CODE Serial numbers 118 - 262.
MANUFACTURER Medical Product Designs, Inc., Indianapolis, Indiana.
-8- RECALLED BY Manufacturer, by letter and by telephone on or about January
1990. Firm-initiated field correction complete.
DISTRIBUTION 9 states (undetermined).
QUANTITY 144 units.
REASON The product is a chiropractic machine for massaging the neck
and the firm was promoting it as a passive traction device.
No proof exists to support claims.
_______________
PRODUCT Bioscan Reagent Strips in bottles which each hold 100 of the
test strips, used as an in-vitro diagnostic aid using urine
specimens: (a) Product #012; (b) Product #020;
(c) Product #021; (d) Product #022; (e) Product #027;
(f) Product #028; (g) Product #026. Recall #Z-106/112-5.
CODE Lot numbers: (a) 270506; (b) 270502; (c) 270506;
(d) 270512; (e) 270511; (f) 270511; (g) 270506.
MANUFACTURER ChungDo Pharmaceutical Company, Ltd., Kyungsangnam-do,
Korea.
RECALLED BY Dia-Screen Corporation, Minneapolis, Minnesota, by letter
October 1, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 5,146 bottles of 100 test strips were distributed
REASON The product gives a false positive test result for protein
in the urine.
MEDICAL DEVICE SAFETY ALERT
==============================================
_______________
PRODUCT Blood cell separators, a self-contained, continuous-flow,
centrifugal Rx device which separates anticoagulated blood
to harvest platelets, plasma, leukocytes and other blood
components during apheresis: (a) CS-3000 Blood Cell
Separators; (b) CS-3000 Plus Blood Cell Separators.
Safety Alert #N-001/002-5.
CODE All serial numbers manufactured from 1979 to the present.
MANUFACTURER Baxter Healthcare, Largo, Florida.
ALERTED BY Baxter Healthcare, Biotech Fenwal Division, Deerfield,
Illinois, by letter August 15, 1994.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 2,576 instruments were distributed.
REASON Blood cell separators could have spillage of blood
undetected to users.
-9-
END OF ENFORCEMENT REPORT FOR NOVEMBER 23, 1994. BLANK PAGES MAY
FOLLOW.
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