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.
February 16, 2000 00-07
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Four Brands of Five Layer Mexican Style Dips (containing layers
of Black and/or pinto beans, fresh salsa, fresh guacamole, nacho
and sour cream):
1. The five layer black bean dips under the following labels:
(a) Senor Felix The Original Five Layer Party Dip in 16 ounce, 20
ounce, 24 ounce, and 41 ounce container sizes;
(b) Trader Joe's Five Layered Fiesta Dip in 20 ounce container.
2. Five layer pinto bean dips under the following labels:
(a) Delicioso 5 layer Dip in 32 ounce containers;
(b) The Carryout Cafe Mexican Fiesta Party Dip 5 Layer in 20
ounce containers. Recall #F-102/103-0.
CODE
All product is being recalled.
MANUFACTURER
Senor Felix's Gourmet Mexican Foods, Inc., Los Angeles,
California.
RECALLED BY
Senor Felix's Gourmet Mexican Foods, Inc., Baldwin Park,
California, by telephone on January 21, 2000, and by press
release on January 22, 2000. Firm-initiated recall ongoing. See
also FDA press release P00-2, January 27, 2000.
DISTRIBUTION
Nationwide.
QUANTITY
The Quantities Distributed Are:
Senor Felix's Five Layer Party Dip w/preservative 8/16 oz.= 196
cases
Senor Felix's Five Layer Party Dip w/out preservative
16 oz.= 1,419 units
Senor Felix's Five Layer Party Dip w/out preservative
8/16 oz. = 275 cases
Senor Felix's Five Layered Party Dip w/ Pinto Beans; w/
Preservatives 8/20 oz. = 934 cases
Delicioso 5 Layer Dip w/preservative 6/32 oz.824 cases
Senor Felix's Five Layer Party Dip w/out preservative
8/20 oz. = 354 cases
Senor Felix's Five Layer Party Dip w/preservative
20 oz. = 12 cases
Senor Felix's Five Layer Party Dip w/out preservative
41 oz. = 46,440 units (Costco product)
Trader Joe's Five Layered Fiesta Dip 20 oz. = 10,314 units
The Carryout Cafe Mexican Fiesta Party Dip 8/20 oz. = 44 cases
(product already destroyed)
REASON
Product may be contaminated with Shigella sonnei.
________
PRODUCT
Good Sense Caribbean Honey! Snack Mix, net weight 7 ounces.
Recall #F-104-0.
CODE
092400A, 011301B,and 011401A.
MANUFACTURER
Waymouth Farms, Inc., New Hope, Minnesota.
RECALLED BY
Manufacturer, by letter on December 27, 1999. Firm-initiated
recall complete.
DISTRIBUTION
New York and Pennsylvania.
QUANTITY
56 cases (12 packages per case) were distributed.
REASON
The papaya in the snack mix contains undeclared FD&C Yellow #5
and FD&C Yellow #6.
________
PRODUCT
Naproxen Tablets, USP, Rx:
a) 250 mg, in 100, 500, 1,000-tablet bottles;
b) 375 mg, in 500-tablet bottles. Recall #D-213/214-0.
CODE
a) NDC# Lot# EXP
0781-1163-13 (UD) 106404 04/01
0781-1163-10 (1000's) 106404 04/02
0781-1163-01 (100's) 106405 04/02
0781-1163-05 (500's) 106405 04/02
0781-1163-10 (1000's) 107022 05/02
0781-1163-01 (100's) 107153 05/02
0781-1163-10 (1000's) 107153 05/02
0781-1163-01 (100's) 107553 06/02
0781-1163-10 (1000's) 107553 06/02
b) NDC# Lot# EXP
0781-1164-05 (500's) 106249 04/02.
MANUFACTURER
Geneva Pharmaceuticals, Inc., Broomfield, Colorado.
RECALLED BY
Manufacturer, by letter on January 21, 2000. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 9,669,500 tablets; b) 2,341,000 tablets were distributed.
REASON
Metal wire/particle contamination.
_______
UPDATE
Recall #D-202-0, Naproxen Tablets, USP, 500 mg, in 100, 500, and
1,000 tablet bottles, Rx (Geneva Pharmaceuticals, Inc.,
Broomfield, Colorado), which appeared in the January 19, 2000
Enforcement Report has been extended to include the following:
NDC# LOT# EXP Distributed (tablets)
0781-1165-10 (1000's) 105841 04/02 1,724,000
0781-1165-10 (1000's) 106208 04/02 1,731,000
0781-1165-10 (1000's) 106209 04/02 1,724,000
0781-1165-01 (100's) 106234 04/02 1,587,900
0781-1165-13 (UD) 106234 04/01 96,300
0781-1165-05 (500's) 106235 04/02 1,709,500
0781-1165-13 (UD) 106442 04/01 96,100
0781-1165-10 (1000's) 106442 04/02 1,627,000
0781-1165-10 (1000's) 106512 04/02 1,722,000
0781-1165-05 (500's) 106753 05/02 1,754,500
0781-1165-05 (500's) 106754 05/02 1,749,000
0781-1165-10 (1000's) 106755 05/02 1,722,000
0781-1165-05 (500's) 106980 05/02 1,704,000
0781-1165-01 (100's) 107145 05/02 1,728,100
0781-1165-10 (1000's) 107146 05/02 1,671,000
0781-1165-10 (1000's) 107245 05/02 1,638,000
0781-1165-05 (500's) 107246 05/02 1,668,000
0781-1165-01 (100's) 107354 05/02 422,000
0781-1165-10 (1000's) 107355 05/02 1,668,000.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-206-0.
CODE
All units produced from September 1997 through January 1998 that
were produced with a Hemasure LeukoNet filter.
MANUFACTURER
American National Red Cross, Arlington, Virginia.
RECALLED BY
Manufacturer, by letters starting May 20, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
9,331 units.
REASON
Blood products were associated with post-transfusion
conjunctivitis.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-376/377-0.
CODE
Unit #20LM63755.
MANUFACTURER
American Red Cross, Boise, Idaho.
RECALLED BY
Manufacturer, by letter dated August 23, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Idaho and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had engaged in
high risk behavior.
________
PRODUCT
a) Red Blood Cells, Leukoreduced; b) Recovered Plasma.
Recall #B-378/379-0.
CODE
Unit #21KF08714.
MANUFACTURER
American Red Cross, Pacific Northwest Regional Blood Services,
Portland, Oregon.
RECALLED BY
Manufacturer, by letter dated September 17, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Oregon and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of
Hepatitis A.
________
PRODUCT
GEN-PROBE Amplified Mycobacterium Tuberculosis Direct Test, an
in-vitro diagnostic device. Recall #Z-173-0.
CODE
DOMESTIC KITS ---
PART NUMBER LOT NUMBER EXPIRATION DATE
301001 905198 3/15/2000
905199 3/15/2000
907382 3/15/2000
INTERNATIONAL KITS ---
PART NUMBER LOT NUMBER EXPIRATION DATE
301001E 905196 3/15/2000
906465 3/15/2000
907383 3/15/2000
301001F 904312 3/15/2000
905246 3/15/2000
906507 3/15/2000
907441 3/15/2000
908161 3/15/2000
301002J 905109 10/28/1999
906255 12/01/1999
907096 12/24/1999
908245 02/02/2000
301011J 905110 10/28/1999
906256 12/01/1999
907097 12/24/1999
908141 02/02/2000.
Each of the aforementioned kit lots has a single unit of
amplification reagent with that reagent lot number of: 90378
****the problem is in the reagent.****
MANUFACTURER
Gen-Probe Inc., San Diego, California.
RECALLED BY
Manufacturer, by letter dated September 20, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,229 kits were distributed.
REASON
The device may produce false negative test results
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
Medtronic Implantable Cardioverter Defibrillators:
a) Medtronic Micro Jewel II Implantable Cardioverter
Defibrillator, Model 7223CX; b) GEM DR Model 7271 Implantable
Cardioverter Defibrillator. Recall #Z-261/262-0.
CODE
All serial numbers of the Model 7223CX; Serial Numbers PIM200002R
through PIM302777R and PIM400352R, PIM400968R, and PIM400969R of
the Model 7271 Defibrillators.
MANUFACTURER
Medtronic Med Rel, Inc., Humaco, Puerto Rico;
Medtronic, B.V., Kerkrade, European Service and Technology
Center, The Netherlands; Medtronic, Switzerland Manufacturing
Operations, Tolochenaz, Switzerland.
RECALLED BY
Medtronic, Inc., Minneapolis, Minnesota, by letter dated August
1999 for the Model 7223CX Defibrillators and by letter dated
December 1999 for the Model 7271 Defibrillators. Devices having
capacitor charge times above a certain level are being
reprogrammed. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 28,000 units were distributed.
REASON
Some of the devices have extended charge times for the high-
voltage capacitors used to store the charge for cardioversion and
defibrillation therapies.
________
PRODUCT
Vitros Immunodiagnostic System, a random access immunodiagnostic
analyzer for quantitative and qualitative determination of
analytes in human specimens. Recall #Z-360-0.
CODE
Catalog #8633893, Serial #30000054-30001120.
MANUFACTURER
Ortho-Clinical Diagnostics, Inc., Rochester, New York.
RECALLED BY
Manufacturer, by letters dated December 28, 1999, and January 13,
2000, and by Technical Bulletin (J11664). Firm-initiated field
correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,066 units were distributed.
REASON
Software error in Vitros ECi Immunodignostic system.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
________
PRODUCT
AgriLabs Agri-Cillin Sterile Penicillin G Procaine Suspension
USP, (Injectable) 300,000 units per ml, in 100 ml, 250 ml, and
500 ml bottles. Recall #V-076-0.
CODE
100 ml - Lot 9043-01
100 ml - Lot 9132-01
250 ml - Lot 8501-06
250 ml - Lot 9044-01
250 ml - Lot 9085-01
250 ml - Lot 9085-02
250 ml - Lot 9085-06
500 ml - Lot 8501-04
500 ml - Lot 9051-01
500 ml - Lot 9092-01
500 ml - Lot 9092-03
500 ml - Lot 9115-01
500 ml - Lot 9125-01
500 ml - Lot 9125-03.
MANUFACTURER
Norbrook Laboratories, Ltd., Newry, County Down, Northern
Ireland.
RECALLED BY
Agri Laboratories, Ltd., St. Joseph, Missouri, by letter dated
December 20, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
73,631 bottles were distributed.
REASON
Bottles may contain glass particles.
________
PRODUCT
Durvet, Pen-Aqueous Sterile Penicillin G Procaine Suspension USP,
(Injectable) 300,000 units per ml, in 100 ml, in 250 ml, and 500
ml bottles. Recall #V-077-0.
CODE
100-ml - Lot 9052-01, EXP Feb 2001
100-ml - Lot 9132-02, EXP Mar 2001
250-ml - Lot 9053-01, EXP Feb 2001
250-ml - Lot 9055-01, EXP Feb 2001
250-ml - Lot 9132-03, EXP Mar 2001
500-ml - Lot 9151-01, EXP Mar 2001.
MANUFACTURER
Norbrook Laboratories Ltd., Newry, County Down, Northern Ireland.
RECALLED BY
Durvet, Inc., Blue Springs, Missouri, by fax on December 9, 1999,
followed by letter on December 15, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
54,148 bottles were distributed.
REASON
Bottles may contain glass particles.
________
PRODUCT
VEDCO Aquacillin, Sterile Penicillin G Procaine Suspension USP,
(Injectable) 300,000 units per ml, in 100 ml, 250 ml, and 500 ml
bottles. Recall #V-078-0.
CODE
100-ml - Lot 9132-02, EXP March 2001
250-ml - Lot 9131-03, EXP March 2001
500-ml - Lot 9125-02, EXP March 2001
500-ml - Lot 9131-02, EXP March 2001.
MANUFACTURER
Norbrook Laboratories, Ltd., Newry, County Down, Northern,
Ireland.
RECALLED BY
VEDCO, Inc., St. Joseph, Missouri, by fax on December 19, 1999,
followed by letter on December 14, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Minnesota, Virginia, Ohio, Colorado, Oklahoma, Indiana, Arizona,
California, Idaho, Washington, Texas, Michigan, Pennsylvania and
South Dakota.
QUANTITY
15,695 bottles were distributed.
REASON
Bottles may contain glass particles.
END OF ENFORCEMENT REPORT FOR FEBRUARY 16, 2000.
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