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.
January 19, 2000 00-03
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________
PRODUCT
Just for You brand Seafood Pasta Salad in clear plastic tub, 12
ounces. Recall #F-081-0.
CODE
All day codes.
MANUFACTURER
Fay's Foods, Inc., North Hollywood, California.
RECALLED BY
Manufacturer, by letter dated September 17, 1999, followed by
telephone on September 20, 1999. Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
Approximately 98 tubs.
REASON
Product contained undeclared egg whites.
________
PRODUCT
Hannaford Chocolate Ice Cream, in 1/2 gallon cartons.
Recall #F-084-0.
CODE
99222 (production date) and H26-426 (plant code).
MANUFACTURER
House of Flavors, Inc., Ludington, Michigan.
RECALLED BY
Manufacturer, by telephone and fax on September 15, 1999, and by
press release on September 16, 1999. Firm initiated recall
complete.
DISTRIBUTION
Maine, New Hampshire, Vermont, Massachusetts, New York, Virginia,
North Carolina, South Carolina.
QUANTITY
1,174 cases (4 units per case) or 4,696 total units were
distributed.
REASON
The Michigan Department of Agriculture found that the product is
contaminated with undeclared peanut protein residue.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Kraft Natural Shredded Mild Cheddar Cheese, in 8-ounce resealable
bags. Recall #F-082-0.
CODE
MAR 19 00 S.
MANUFACTURER
Hilmar Cheese Company, Hilmar, California.
RECALLED BY
Kraft Foods, Inc., Northfield, Illinois, by letter on December
10, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Missouri and Kansas.
QUANTITY
630 cases (12 bags per case) were distributed; firm estimated
that 20 percent of product remained on market at time of recall
initiation.
REASON
Product may contain pieces of wood.
________
PRODUCT
Albertson's Tin Roof Sundae Ice Cream Chocolate Covered Almonds
and Chocolate Syrup, in 1/2 gallon cardboard cartons.
Recall #F-083-0.
CODE
40400 16 5.
The code should read 40400 16-15. The "1" represents the plant
code. However, the plant number digit was left out because that
equipment was being repaired.
MANUFACTURER
Albertson's, Inc., Boise, Idaho.
RECALLED BY
Manufacturer, by E-mail and or by fax on October 22, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Oregon, Washington state, Idaho.
QUANTITY
3,738 cartons were distributed.
REASON
Product is contaminated with ammonia.
________
PRODUCT
Dihydroergotamine Mesylate Powder, Rx bulk active ingredient, in
250 mg, 1 g and 5 g containers.
Recall #D-201-0.
CODE
Lot Numbers: NL0465, OC0650, OG0622. EXP 05/31/02 for all lots.
MANUFACTURER
Spectrum Laboratory Products, Inc., Gardena, California
(repacker/responsible firm).
RECALLED BY
Repacker, by letter on December 10, 1999, followed by telephone
on or about December 27, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
California, Colorado, Georgia, North Carolina, Oregon, Rhode
Island, Texas, Utah.
QUANTITY
20 grams were distributed.
REASON
Possible cross contamination with cefadroxil.
________
PRODUCT
Naproxen Tablets, USP, 500 mg, in 100, 500 and 1,000 tablet
bottles, Rx. Recall #D-202-0.
CODE
NDC# (TABS) Lot# EXP
0781-1165-10 (1000's) 106583 04/02
0781-1165-05 ( 500's) 106584 04/02
0781-1165-01 ( 100's) 106585 05/02
0781-1165-10 (1000's) 106585 05/02
0781-1165-05 ( 500's) 105921 04/02
0781-1165-05 ( 500's) 106119 04/02.
MANUFACTURER
Geneva Pharmaceuticals, Inc., Broomfield, Colorado.
RECALLED BY
Manufacturer, by letter on December 17, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Lot# Distributed
106583 (1000's) 1,719,000
106584 ( 500's) 1,569,500
106585 ( 100's) 489,600
106585 (1000'S) 971,000
105921 (500'S) 1,743,500
106119 (500'S) 1,716,500.
REASON
Metal wire/particle contamination.
________
PRODUCT
Oxytocin Injection, USP (synthetic), 10 USP units/mL, 1 mL,
(3cc plastic vial), Rx indicated for the initiation or improvement of
uterine contractions to induce labor.
NDC #N0469-002-061. Recall #D-204-0.
CODE
Lot #392002 EXP 04/00.
MANUFACTURER
American Pharmaceutical Partners, Inc., Grand Island, New York.
RECALLED BY
Manufacturer, by letter dated December 20, 1999. Firm-initiated
recall ongoing.
DISTRIBUTIONB
Nationwide.
QUANTITY
294,350 units were distributed; firm estimates none remains on
the market.
REASON
Subpotency.
________
PRODUCT
Radic Electrolyte Formula, liquid, in 8-ounce clear plastic
bottles, OTC dietary supplement to help the body heal itself
naturally. Recall #D-205-0.
CODE
Uncoded. All 8-ounce product.
MANUFACTURER
Medical Research Products, also known as Consolidated Marketing
Ltd., Miami, Florida.
RECALLED BY
Hope For Life Foundation of Southern California, Mission Viejo,
California, by telephone beginning December 15, 1999. Firm-
initiated recall complete.
DISTRIBUTION
California and Nevada.
QUANTITY
Approximately 20 bottles were distributed; firm estimates none
remains on the market.
REASON
Product contains catechol (carcinogen).
_______
STRONG>UPDATE
Recall numbers for various pharmaceutical ingredients which
appeared in the January 12, 2000 Enforcement Report should read:
Product (A) Recall #D-162/177-0;
Product (B) Recall #D-178/184-0.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Diltiazem Hydrochloride Extended Release Capsules, USP, 120 mg,in
100-capsule bottles, Rx indicated for angina pectoris due to
coronary artery spasms. Recall #D-200-0.
CODE
Lot #11829 EXP 2/01.
MANUFACTURER
Teva Pharmaceuticals USA, Sellersville, Pennsylvania.
RECALLED BY
Manufacturer, by letter on December 23, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
9,597 bottles were distributed.
REASON
Dissolution failure at 3 months stability.
________
PRODUCT
Quinidine Gluconate Extended Release Tablets, USP, 324 mg, in
100, 250, and 500-tablet bottles, Rx used as an antimalaria and
antiarrhythmic. Recall #D-203-0.
CODE
NDC-0364-0604-01 bottles of 100's; C8D0669 (04/00), C8D0670
(04/00), C8E1066 (06/00), C8E1068 (06/00), C8F1173 (07/00),
C8F1174 (07/00), C8F1234 (08/00)
NDC-0364-0604-04 bottles of 250's; C8B0265 (04/00), C8B0266
(04/00), C8D0671 (04/00), C8D0672 (04/00), C8D0673 (04/00),
C8E1070 (06/00), C8E1071 (06/00), C8F1170 (07/00), C8F1171
(07/00), C8F1235 (08/00)
NDC-0364-0604-05 bottles of 500's; C8B0263 (04/00), C8B0264
(04/00), C8E1067 (06/00)
MANUFACTURER
Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY
Schein Pharmaeuticals, Inc., Brewster, New York, by letter dated
December 22, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
15,682 bottles of 100's; 12,530 bottles of 250's
1,838 bottles of 500's were distributed.
REASON
Product may not meet dissolution specification over labeled
expiration period.
________
PRODUCT
Cyclosporine, USP, Non-Sterile, powder, bulk active ingredient,
Rx immunosuppressant agent used for the prophylazis of organ
rejection in kidney, liver and heart allogenic transplants, in
various sizes.
Recall #D-206-0.
CODE
Lot Numbers: 49-365-IL-00 and 51-379-IL-00.
MANUFACTURER
Abbott Laboratories, Chemical and Agricultural Products Division,
North Chicago, Illinois.
DISTRIBUTION
California, Indiana, Florida, Texas, Illinois.
QUANTITY
57.76 kg of bulk drug were distributed.
REASON
Product failed hexane impurity level.
________
PRODUCT
X-Ray Fluorescence Spectrometers, used for the qualitative and
quantitative elemental analysis of material composition and
thickness by X-ray fluorescence spectroscopy:
a) Model No. 0700; b) Model No. 770;
c) Model No. 771; d) Model No. 0750. Recall #Z-068/071-0.
CODE
Model Numbers 0700, 770, 771, and 0750.
MANUFACTURER
Kevex Instruments, Inc., Sunnyvale, California.
RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan on
August 13, 1999. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
309 units were distributed.
REASON
These analytical X-ray systems are defective as defined by 21 CFR
1003.2. The relay controlling the interlock for the sample
chamber, indicator light, and X-ray power can potentially fail.
________
PRODUCT
6.5 mm Cannulated Tap for proximal hip pin, used to tap a hole in
the bone prior to the placement of a hop pin (screw). Recall #Z-293-0.
CODE
Part #311.720, Lot Numbers: 1002 and 1008.
MANUFACTURER
Stratec Medical, Oberdorf, Switzerland.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by letter on March 5, 1998.
Firm-initiated recall complete.
DISTRIBUTION
California, Connecticut, Illinois, New Jersey, Canada.
QUANTITY
10 units were distributed.
REASON
Product does not meet hardness specifications.
________
PRODUCT
Depuy LCS Total Knee System Rotating Platform:
a) Size STD/LG, Part No. 1278-46-025,
b) Size STD+/LG, Part No. 1278-51-025.
Recall #Z-310/311-0.
CODE
Lot Numbers: a) 051799001; b) 051799002.
MANUFACTURER
Depuy Orthopaedics Inc., Warsaw, Indiana.
RECALLED BY
Manufacturer, by telephone on May 14, 1999, and by letter sent on
May 17, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, California, Colorado, Florida, Georgia, Illinois, Iowa,
Massachusetts, Michigan, Montana, Missouri, New York, Tennessee,
Utah, Virginia, England.
QUANTITY
50 units were distributed.
REASON
Two lots were mixed during manufacturing. The difference between
the devices is a slight mismatch between the curvature of the
femoral and tibial insert (approximately 5mm).
________
PRODUCT
Swan-Ganz Bipolar Pacing Catheter Model 97K125F5, designed for
temporary transvenous right ventricular endocardial pacing.
Recall #Z-312-0.
CODE
Lot Numbers: 219HC569, 219HC570, 219HC571, 219HC572 and
219HC573.
MANUFACTURER
Baxter Healthcare Corporation, Anasco, Puerto Rico.
RECALLED BY
Baxter Healthcare Corporation, Irvine, California, by letter sent
on November 6, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
716 individual units were distributed.
QUANTITY
Nationwide and international.
REASON
The labeling on the box and tray indicates that the product is
for femoral insertion rather than for Superior Vena Cava (SVC)
insertion.
________
PRODUCT
Management Systems, intended to provide continuous infusion of a
local anesthetic directly into an intra-operative site for
postoperative pain management:
a) ON-Q Pain Management System; b) Pain-Buster Pain Management
System. Recall #Z-313/314-0.
CODE
All lot numbers.
MANUFACTURER
I-Flow Corporation, Lake Forest, California.
RECALLED BY
Manufacturer, by letter on November 12 and 29, 1999, and by
technical bulletin sent on November 22, 1999. Firm-initiated
field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) Approximately 5,169 cases (5 units per case); b) 25,250 units
were distributed.
REASON
The devices contain natural rubber latex components and the label
fails to declare, "Caution: This product contains natural rubber
latex which may cause an allergic reaction."
________
PRODUCT
Philips BV26 Mobile C-Arm Stand Mobile C-Arm Fluoroscope. The
unit consists of a mobile C-arm stand with X-ray generator,
medical imaging chain and control.
Recall #Z-316-0.
CODE
Philips Medical Systems Model BV26 with Serial Numbers: CBxxxx,
CDxxxx, CGxxxx.
MANUFACTURER
Philips Medical Systems Nederland B.V., Best Netherlands.
RECALLED BY
Philips Medical Systems North America, Inc., Shelton,
Connecticut, by issuing a field change order dated May 1999, on
September 18, 1999. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
70 units.
REASON
The wheel plates may fail causing the BV26 to fall.
________
PRODUCT
Series 200 5 French Angiographic Balloon Catheter, designed for
use in right heart catherization for cardiac angiography, and
pulmonary angiography:
a) Model No. 252-50; b) Model No. 252-60;
c) Model No. 252-80. Recall #Z-317/319-0.
CODE
Lot Numbers: a) 2021, 172963, 144951;
b) 1449151, 50922; c) 1449111, 172961, 172962, 172964, 172965,
116951, 116981, 116982, 307821, 013911, 013921.
MANUFACTURER
J-Lloyd Medical, Inc., West Berlin, New Jersey.
RECALLED BY
Manufactuer, by fax on October 29, 1999, followed by telephone,
and by letter on November 5, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Texas, Canada, England.
QUANTITY
419 units were distributed.
REASON
The catheter tip may break just proximal to the balloon.
________
PRODUCT
ES 4007 Universal Cord, a reusable device that combines the
function of a standard electrosurgical active cord with the
electroshield cable in one cable. This allows the user to make a
single termination of the ESU/EM equipment and a single
termination at the surgical instrument.
Recall #Z-320-0.
CODE
Lot Codes BI, BIA, BIB, BJ, CB, CBA, CBB, DA, DB, DG, DGA, DGB,
DGC.
MANUFACTURER
Electroscope, Inc., Boulder, Colorado.
RECALLED BY
Manufacturer, by letter on December 15, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide, Canada, Australia.
QUANTITY
1,361 cords were distributed.
REASON
A fatigued active conductor could result in a spark and burning
of the cord insulation.
________
UPDATE
Pelvic Implant Set Graphic Case for Self-Taping Screws was
printed in duplicate in the November 3, 1999, Enforcement Report.
The correct recall number for this product is
Recall #Z-077-0.
________
UPDATE
Recall #Z-265/266-0, Ancure Endograft System, which appeared in
the December 29, 1999 Enforcement should be corrected as follows:
CODE
All devices with serial numbers less than 9C12980*, with the
following exceptions:
9C12261 T 9C12596 T 9C12605 T 9C12825 T 9C12928 T
9C12955 T 9C12273 T 9C12597 T 9C12608 T 9C12827 T
9C12929 T 9C12956 T 9C12275 T 9C12598 T 9C12609 T
9C12831 T 9C12930 T 9C12957 T 9C12276 T 9C12599 T
9C12610 T 9C12832 T 9C12931 T 9C12958 T 9C12490 T
9C12600 T 9C12611 T 9C12894 T 9C12932 T 9C12567 T
9C12601 T 9C12762 T 9C12895 T 9C12953 T 9C12595 T
9C12604 T 9C12823 T 9C12898 T 9C12954 T
* The last character is an Alpha character and is not part of the
serial number sequence.
MANUFACTURER
Guidant Corporation, Cardiac & Vascular Surgery Group, Menlo
Park, California.
QUANTITY
287 units.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
TECAN Genesis Disposable 1000ul Filter DiTi Tips, Catalog No. 71-
705. Recall #Z-309-0.
CODE
Lot Numbers: 15169, 16169, 17169, 11179, 25169, 26169, 27169,
35169, 36169, and 37169.
MANUFACTURER
Eppendorf, Barkhausenweg-1, Germany.
RECALLED BY
Tescan U.S., Inc., Durham, North Carolina, by letter on October
4, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Arizona, California, Florida, Illinois, Wisconsin.
QUANTITY
2,720 boxes were distributed.
REASON
The device delivers incorrect volumes.
________
PRODUCT
Fresenius Kidney Euro-Collins Perfusion Set, 1 liter.
Recall #Z-315-0.
CODE
Catalog #2398001, Lot #9NR816.
MANUFACTURER
Fresenius Medical Care, North America, CD Reynosa Tamps, Mexico.
RECALLED BY
Fresenius USA Manufacturing, Inc., Lexington, Massachusetts, by
telephone beginning on December 17, 1999, followed by fax
beginning on December 17, 1999, and completed by December 23,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Arkansas, Arizona, Kansas, Indiana, Louisiana, Michigan, New
York, Oregon, Pennsylvania, Texas, Utah.
QUANTITY
61 units.
REASON
Outer case label has extended expiration date.
MEDICAL DEVICE SAFETY ALERT:
________
PRODUCT
Endopath ETS45 Endoscopic Linear Cutter, used in general,
gynecologic, thoracic, and urologic surgery to deliver staples
while simultaneously dividing tissue between rows.
Safety Alert #N-005-0.
CODE
All Endoscopic Linear Cutters, Model ETS45, manufactured since
January 1999.
MANUFACTURER
Ethicon Endo-Surgery, Inc, Cincinnati, Ohio.
ALERTED BY
Manufacturer, by letter dated December 10, 1999.
DISTRIBUTION
Nationwide and international.
QUANTITY
49,163 units.
REASON
Surgeons are using the device for tissue thickness beyond the
specified range.
END OF ENFORCEMENT REPORT FOR JANUARY 19, 2000.
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