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 11, 1998 98-45

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT
Quesos Puebla Mexican Style Fresh White Cheese, 14 ounces. Recall #F-028-9.

CODE
"JUL 22, 1998".

MANUFACTURER
Quesos Puebla, Brooklyn, New York.

RECALLED BY
Manufacturer, by telephone on July 27, 1998. Completed recall resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
Firm estimates none remains on the market.

REASON
Product is contaminated with Listeria monocytogenes.

PRODUCT
Queseria Zurita Spanish White Cheese, in foil wrap packages, 14 ounces. Recall #F-031-9.

CODE
May 30.

MANUFACTURER
Zurita Cheese, Brooklyn, New York.

RECALLED BY
Manufacturer, by visit on or about May 26, 1998, and by press release issued by the New York State Department of Agriculture and Markets (NYSDAM) on May 26, 1998. Completed recall resulted from sample analysis and follow-up by NYSDAM.

DISTRIBUTION
New York.

QUANTITY
120 units were distributed.

REASON
Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

PRODUCT
Product: Leslie Cheese Flavor Clover Chips, in 6.4 ounce aluminum foil bags. Recall #F-021-9.

CODE
1210411.

MANUFACTURER
Leslie Corporation, Paranaque, Manila, Phillippines.

RECALLED BY
Summit Import Corporation, New York, New York, by letter dated September 8, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
North Carolina, Florida, New Jersey, New York, Maryland.

QUANTITY
40 cases were distributed.

REASON
Product contained undeclared colors certifiable as FD&C Yellow No. 5 and FD&C Yellow No. 6.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

PRODUCT
Pillsbury Pet-Ritz Pie Crusts: a) Pillsbury Pet-Ritz Pie Crusts, Regular, 5 crusts in 9-inch ready to fill pans, 25 ounces, 2 crusts in 9-inch ready to fill pans, 10 ounces; b) Pillsbury Pet-Ritz Pie Crusts, Deep Dish, 2 crusts in 9-inch ready to fill pans, 12 ounces; c) Pillsbury Pet-Ritz Pie Crusts, All Vegetable, 2 crusts in 9-inch ready to fill pans, 12 ounces. Recall #F-025/027-9.

CODE
Cases are coded 072798L through 091798L, retail packages are coded G8Lxx where xx = 27 through 31, H8Lxx where xx = 01 through 31, and I8Lxx where xx = 01 through 17.

MANUFACTURER
The Pillsbury Company, Lithonia, Georgia.

RECALLED BY
The Pillsbury Company, Minneapolis, Minnesota, by electronic mail on September 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
39,892 cases containing 12 10 or 12-ounce retail bags of the crusts, or 6 of the 25 ounce boxes were distributed.

REASON
The products are unfit for food because colors migrated to the crusts from the product label.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT
Premarin Tablets (Conjugated Estrogens Tablets, USP), 1.25 mg, in bottles of 100. Recall #D-012-9.

CODE
Lot number 8G01759.

MANUFACTURER
Ayerst-Wyeth Pharmaceuticals, Inc., Guayama, RQ.

RECALLED BY
Leiner Health Products, Madison, Wisconsin, by letter on September 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
16,004 bottles were distributed.

REASON
Mislabeling - One bottle labeled by Leiner Health Products as Premarin 1.25 mg tablets actually contained Buspar 10 mg tablets (Buspirone HCL USP).

UPDATE Recall # D-006/009-9 (Inwood Labs) Propranolol HCl ER 60 mg capsules, lot 8A38 (1/99), which appeared in the November 4, 1998 Enforcement Report should read lot 8A038.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

PRODUCT
Astra Rhinocort Nasal Inhaler(Budesonide), 7 g, in 200 meter doses, an anti-inflammatory glucocorticosteroid. NDC #0186-1075-PS. Recall #D-011-9.

CODE
Lot #XI-110 EXP 9/98.

MANUFACTURER
3M Healthcare, Loughborough, UK.

RECALLED BY
Astra USA, Inc., Westborough, Massachusetts, by letter starting the first week of October 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
91,704 units were distributed.

REASON
Product exceeds total degradation specification (stability testing).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

PRODUCT
Platelets, Pheresis, Irradiated. Recall #B-067-9.

CODE
Units 07FM06232, 07FM06235.

MANUFACTURER
American Red Cross, Tucson, Arizona.

RECALLED BY
Manufacturer, by letter dated April 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
2 units were distributed.

REASON
Platelets were shipped at an unacceptable temperature.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma for Further Manufacture. Recall #B-097/098-9.

CODE
Unit #42T55014.

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letter dated March 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Massachusetts.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of exposure to hepatitis.

PRODUCT
Red Blood Cells. Recall #B-099-9.

CODE
Unit #N37898.

MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.

RECALLED BY
Manufacturer, by letter dated July 10, 1997. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor taking the drug Cytotec (misoprostol).

PRODUCT
Platelets. Recall #B-100-9.

CODE
Unit #1501245.

MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.

RECALLED BY
Manufacturer, by telephone on July 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor taking the drug Lodine (etodolac).

PRODUCT
Platelets, Pheresis. Recall #B-101-9.

CODE
Unit #50P20560.

MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.

RECALLED BY
Manufacturer, by letter dated July 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for the CMV, but was collected from a donor who previously tested CMV positive.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-102/104-9.

CODE
Unit numbers: a) 5024208, 5024226, 5024232; b) 5024232; c) 5024216, 5024226, 5024250, 5024256.

MANUFACTURER
BloodCare, Dallas, Texas.

RECALLED BY
BloodCare, doing business as Carter Blood Center, Bedford, Texas, by letter dated April 28, 1998, and/or by fax on April 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and Switzerland.

QUANTITY
a) 3 units; b) 1 unit; c) 4 units were distributed.

REASON
Blood products were collected from donors whose arm had not been adequately prepared prior to venipuncture.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-105/106-9.

CODE
Unit numbers: a) 18215-1277, 18215-1273, 18215-1029, 18215-1030, 18215-1322; b) 18215-1277, 18215-1273, 18215-1274.

MANUFACTURER
United Blood Services, Cheyenne, Wyoming.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 24, 1997 or October 31, 1997, and by letter dated November 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois, North Carolina, Wyoming.

QUANTITY
a) 5 units; b) 3 units were distributed.

REASON
Blood products were collected in a manner that compromised the sterility of the units.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-107/109-9.

CODE
Unit #V57551.

MANUFACTURER
Mississippi Valley Regional Blood Center, Davemport, Iowa.

RECALLED BY
Manufacturer, by letter dated March 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana, Virginia, California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood product was collected from a donor who within the previous 12 months had lived in a household with a mother who had hepatitis.

PRODUCT
a) Red Blood Cells; b) Fresh frozen Plasma; c) Recovered Plasma. Recall #B-111/113-9.

CODE
Unit numbers: a) 6164591; b) 4648686; c) 6164591.

MANUFACTURER
BloodCare, Dallas, Texas.

RECALLED BY
BloodCare, doing business as Carter BloodCare, Bedford, Texas, by letter dated either June 12 or 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of hepatitis.

PRODUCT
Whole Blood. Recall #B-114-9.

CODE
Unit #5010352.

MANUFACTURER
BloodCare, Dallas, Texas.

RECALLED BY
BloodCare, doing business as Carter BloodCare, Bedford, Texas, by letter dated August 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who had engaged in high risk behavior.

PRODUCT
a) Red Blood cells; b) Platelets. Recall #B-117/118-9.

CODE
Unit #01GL02017.

MANUFACTURER
American Red Cross Blood Services, Syracuse, New York.

RECALLED BY
American Red Cross Blood Services, Rochester, New York, by letter dated November 18, 1997. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-119/120 -9.

CODE
Unit #01LW08212.

MANUFACTURER
American Red Cross Blood Services, Buffalo, New York.

RECALLED BY
American Red Cross Blood Services, Rochester, New York, by telephone on April 6, 1998, and by letter dated April 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were contaminated with coagulase negative staphylococcus.

PRODUCT
Platelets, Pheresis. Recall #B-121-9.

CODE
Unit #01FP03682.

MANUFACTURER
American Red Cross Blood Services, Albany, New York.

RECALLED BY
American Red Cross Blood Services, Rochester, New York, by telephone on December 11, 1997, and by letter dated January 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Platelets, Pheresis had a high white cell count.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

PRODUCT
Platelets. Recall #B-090-9.

CODE
Unit #18214-7380.

MANUFACTURER
United Blood Services, Cheyenne, Wyoming.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 24, 1997. Firm-initiated recall complete.

DISTRIBUTION
North Carolina.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a unit of whole blood with an extended collection time.

PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced by Filtration. Recall #B-125/126-9.

CODE
Unit Numbers: a) 12427-8445, 12427-8444, 12427-8443, 12427-8442, 12427-8441, 12427-8440, 12427-8439, 12427-8438, 12427-8435, 12427-8434, 12427-8433, 12427-8431, 12427-8427, 12427-8437; b) 12427-8436.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona, New Mexico, Texas.

QUANTITY
a) 14 units; b) 1 unit.

REASON
Blood products were labeled with extended expiration dates.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

PRODUCT
Universal Clinical Workstation (UCW), Monitor Model 90385, a generic display device with networking and data management capabilities. Recall #Z-834-8.

CODE
All units shipped prior to 3/97. Serial numbers used by the firm are not sequential.

MANUFACTURER
Spacelabs Medical, Redmond, Washington.

RECALLED BY
Manufacturer, by Product Service Notice (PSN) 076-0469-00 dated September 16, 1996 and PSN 076-0541-00 dated February 7, 1997. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
3,328 monitors are affected by this field correction.

REASON
Base screws are too short which could allow the monitor to dislodge from wall mounted base.

PRODUCT
Leksell GammaPlan (LGP) Version 4.01-4.11, software is designed for use with the Leksell Gamma Knife. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Recall #Z-118-9.

CODE
Leksell GammaPlan (LGP) Versions 4.01-4.11.

MANUFACTURER
Elekta AB, Stockholm, Sweden.

RECALLED BY
Elekta Instruments, Inc., Atlanta, Georgia, by technical alert sent dated June 1997. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
38 units were distributed.

REASON
An error in the plug command which caused the dose planning software GammaPlan to give too long treatment times, meaning that the patient receives a higher dose than prescribed.

PRODUCT
Leksell GammaPlan (LGP) Versions 3.0 and KULA used in conjunction with Elekta's Gamma Knife. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Recall #Z-120-9.

CODE
Leksell GammaPlan Version 3.0 and KULA. The KULA version is the predecessor of the Leksell GammaPlan.

MANUFACTURER
Elekta AB, Stockholm, Sweden.

RECALLED BY
Elekta Instruments, Inc., Atlanta, Georgia, by product bulletin dated July 1, 1996. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
38 units were distributed.

REASON
A calculation error in the dose planning system may, under unusual circumstances, result in the miscalculation of the distance form the skull boundary to the intended target, resulting in a dose lower than prescribed.

PRODUCT
Leksell Gamma Knife, Models U and B. The model U represents the majority of the units in the United States. Model B is the newer version of the Gamma Knife, used for the non-invasive treatment of selected intracranial disorders. Recall #Z-121-9.

CODE
Models U and B.

MANUFACTURER
Elekta AB, Stockholm, Sweden.

RECALLED BY
Elekta Instruments, Inc., Atlanta, Georgia, by Technical Note #006 dated November 1996. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
38 units were distributed.

REASON
Complaints involving lacerations of fingers and entrapment of an elbow during use of the device.

PRODUCT
Biotrack Protime Reagent Cartridges CoaguChek Plus Prothrombin Time (PT) Test Cartridges: a) Biotrack Protime Reagent Cartridges, Catalog No. 473043; b) CoaguChek Plus PT Test Cartridges, Catalog No. 473707. Recall #Z-122/123-9.

CODE
a) All Lot Numbers which begin with P616 and P702; b) All Lot Numbers which begin with P616 and P702.

MANUFACTURER
Boehringer Mannheim Corporation, Fremont, California.

RECALLED BY
Boehringer Mannheim Corporation, Indianapolis, Indiana, by telephone in November 1997, and by letter dated July 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Australia, Canada, Chili, Germany, Japan, Switzerland.

QUANTITY
9,427 boxes of CoaguChek plus and 4479 boxes of Coumatrak Protime were distributed since November 20, 1996.

REASON
When used with the Protime Controls these cartridges give results which are out of published range.

PRODUCT
Sunmark brand Heat Therapy Heating Pads:

a) Sunmark brand Dry Heat Therapy Heating Pad,  Model No. 2000;
b) Sunmark Brand Dry/Moist Heat Therapy Heating Pad, 
   Model No. 2025;
c) Sunmark Brand Dry/Moist Heat Therapy Heating Pad, 
   Model No. 2050.  Recall #Z-124/126-9.

CODE
All units.

MANUFACTURER
Square Fund Industrial Limited, Shenzhen, China.

RECALLED BY
Homedics, Inc., Keego Harbor, Michigan, by letter dated March 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 14,674 pads were distributed.

REASON
Scorching of the heating pads and overlying materials may occur when the product is in use.

PRODUCT
Anesthesia Gas Sampling Elbow and Anesthesia Circuits containing this elbow:

 
a) Gibeck Anesthesia Gas Sampling Elbow, Part No. 92001;
b) Datex-Ohmeda brand ET ELBOW ADAPTER(X10) Anesthesia Circuit,
Catalog No. 6027-0000-020,;
c) Gibeck brand anesthesia circuits which contain the Gas
Sampling Elbow, Part No. 92001.  Recall #Z-141/143-9.

CODE
All lots produced prior to 10/27/97:

a) Part #92001; b)  Lot No. M039034
c) Gibeck brand anesthesia circuits which contain the Gas
Sampling Elbow, Part No. 92001, as follows:
Catalog Number Lot Numbers
10311          M039005
130-0003-064   C042072
13005-230      M038708
13201-683      C042046
13300-951      C041902
13401-951      C042048
140-0000-371   C041815
140-0000-868   C041738
140-0002-296   C041743
140-0004-484   C041816
14111-BMK      C041839
14211-951      C041817
16002-951      C041751
16003-BLS      C041697
16003-951      C040029, C041996, C042007
16303-951      C041644
16013-951      C041755
16013-959      C041653
16203-951      C041864
16313-951      C041819
16401-951      C041814
16411-596      C041759
16411-798      C041999
16411-951      C041756
16412-BHS      C041792
170022-951     C041761, C041798
170032-269     C041844
170032-798     C041695
170032-951     C041275, C041674, C041684, C041736, C041845,
               C041861, C041903
170032-BDB     C041867
170032-BFB     C041781
170032-BLL     C041843
170132-475     C041763
170232-951     C041656, C041728, C041791, C041985
172032-951     C041824
173032-951     C041918
173132-951     C041767
174112-951     C041708, C041965
301-0002-769   C041826, C041862
301-0002-774   C041770
302-0000-230   C041796
302-0000-537   C041846
302-0000-701   C041888
302-0001-214   C041711
302-0001-342   C041680
302-0001-402   C041737, C041942
302-0001-702   C041869
302-0001-868   C041827
302-0002-495   C041712
302-0002-506   C041991
302-0002-775   C041847
302-0003-060   C041848
302-0003-502   C041724
302-0003-564   C041700
302-0003-692   C041731
302-0003-907   C041701
302-0003-919   C041799
302-0004-408   C041836
304-0002-123   C041746
304-0002-173   C041773
304-0002-673   C042107
304-0003-625   C041704
304-0004-234   C041930
305-0000-319   C041797
305-0001-824   C041957
MM15207-304    M038283.

MANUFACTURER
Gibeck, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by letter dated June 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, France, Germany, Slovenia.

QUANTITY
23,013 units were distributed.

REASON
The bend in the elbow was 99% occluded.

PRODUCT
Pharmacia brand Superblade Trephine (Surgical Blade Assembly), single use only, used in corneal transplant surgery:

a) Model No. 15-0140-65;
b) Model No. 15-0140-67;
c) Model No. 15-0140-70;
d) Model No. 15-0140-72;
e) Model No. 15-0140-75;
f) Model No. 15-0140-77;
g) Model No. 15-0140-80;
h) Model No. 15-0140-82;
I) Model No. 15-0140-85;
j) Model No. 15-0140-87;
k) Model No. 15-0140-90;
l) Model No. 15-0140-92;
m) Model No. 15-0140-95.  Recall #Z-158/170-9.

CODE
All blades distributed between 9/93 and 9/98.

MANUFACTURER
Pharmacia & Upjohn Groningen BV, Groningen, Netherlands.

RECALLED BY
Pharmacia & Upjohn Company, Kalamazoo, Michigan, by telephone between October 2 and 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
13,050 blades were distributed between 9/93 and 9/98.

REASON
The blades may become dulled prior to use, due to failure of proper fit in their protective packaging.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

PRODUCT
Leksell GammaPlan (LGP) Versions 3.01, software designed for use with the Leksell Gamma Knife, intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. Recall #Z-119-9.

CODE
Software version 3.01.

MANUFACTURER
Elekta AB, Stockholm, Sweden.

RECALLED BY
Elekta Instruments, Inc., Atlanta, Georgia, by releasing a new version of software in July 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
38 units were distributed.

REASON
Instead of using the 50% line, the default dose setting was used resulting in the administration of 10Gy rather than 22Gy resulting in underdose.

PRODUCT
Model No. 1100 Calibration Solution Pack for the SenDx 100 Blood Chemistry Analyzer, for in-vitro diagnostic use. Recall #Z-127-9.

CODE
Lot numbers 51501 and 51525.

MANUFACTURER
SenDx Medical, Inc., Carlsbad, California.

RECALLED BY
Manufacturer, by telephone and by letter dated September 24, 1998. Firm-initiated field correction complete.

DISTRIBUTION
California, Idaho, Florida, Georgia, Indiana, Louisiana, New Jersey, Ohio, Pennsylvania, Japan, Denmark.

QUANTITY
68 units were distributed.

REASON When used with the sensor cassette this calibration pack gives falsely elevated pCO2 values.

END OF ENFORCEMENT REPORT FOR NOVEMBER 11, 1998. BLANK PAGES MAY FOLLOW.

####