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 contain s information on actions taken in connection with agency regulatory activities.

ENFORCE 10/15/1996 ENFORCEMENT REPORT FOR 10/16/96

October 16, 1996

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Creamette brand Macaroni and Cheese Dinners,
packed in 7.25 ounce cardboard cartons.
Recall #F-009-7.
CODE Lot numbers P6165B1N and P6165C1N.
MANUFACTURER The Creamette Division, Borden Foods
Corporation, New Hope, Minnesota.
RECALLED BY Borden Foods Corporation, Columbus, Ohio, by
press release issued on September 27, 1996,
and by fax recall notices. Firm-initiated
recall ongoing.
DISTRIBUTION Indiana, Wisconsin, Illinois, Minnesota, Ohio,
Michigan, Nebraska, Washington state,
Colorado.
QUANTITY 1,079 cases of lot P6165B1N and 695 cases of
lot P6165C1N were distributed.
REASON Product contains metal pieces.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Mother's Natural Plain Rice Cakes, sodium
free, in 4.5 ounce plastic sleeve containing
14 cakes. Recall #F-008-7.
CODE Package lot: OCT 19 96 U1B - case lot: APR
22 96 UB.
MANUFACTURER The Quaker Oats Company, Putney, Vermont.
RECALLED BY The Quaker Oats Company, Chicago, Illinois, by
telephone on June 25, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana, Tennessee, Connecticut, Georgia, New
York.
QUANTITY 125 cases (12 sleeves per case) were
distributed.
REASON The rice cakes are salted and do not qualify
for the "sodium free" claim on the label.

_______________
UPDATE Recall #F-616/617-6 which appeared in the
September 25, 1996 Enforcement Report should
be replaced with the following:
_______________
PRODUCT Buena Vida Queso Blanco White Cheese and Queso
Para Freir White Cheese in approximately 2 1/2
and 5-pound plastic wrapped pieces:
(a) Buena Vida Queso Blanco White Frying
Cheese
(b) Tut's Spanish Cheese
(c) Gold Star Village Cheese
(d) Goya Queso Blanco Del Pais White Cheese
(e) Blue Cock Queso Blanco Gayo Azul Finest
White Cheese
(f) Buena Vida Queso Blanco White Cheese
(g) Buena Vida Queso Para Freir White Cheese.
Recall #F-001/007-7.
CODE All lots still in distribution.
MANUFACTURER Avonmore Cheese, Inc., Kent, Illinois.
RECALLED BY Avonmore Cheese, Inc., Monroe, Wisconsin, by
retrieving product during the week of June 17,
1996. Firm-initiated recall complete.
DISTRIBUTION New York, New Jersey.
QUANTITY Approximately 36,100 pounds were on the market
at time of recall initiation.
REASON Products were unfit for food due to swollen
packages resulting from gas formation.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT Wet'n'Wild brand Matte Finish Liquid Makeup,
Ivory Bisque Shade, Item 841A, packaged in 1
fluid ounce/29 ml glass bottles.
Recall #F-636-6.
CODE 68091.
MANUFACTURER Tri-Tech Laboratories, Lynchburg, Virginia.

-2-RECALLED BY Pavion Limited, Nyack-on Hudson, New York, by
telephone beginning on June 26, 1996, followed
by letter July 9, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 8,966 bottles were distributed.
REASON Product is contaminated with Pseudomonas
aeruginosa.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============
_______________
PRODUCT Phyne Pharmaceuticals brand Adrenal Cortex
Extract Injectable in 30 ml multi-dose vials,
Rx. Recall #D-254-6.
CODE All Codes.
MANUFACTURER Undetermined.
RECALLED BY Phyne Pharmaceuticals, Scottsdale, Arizona,
(distributor), by letter September 17, 1996.
Firm-initiated recall ongoing. See also FDA
press release P96-13, August 30, 1996.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Mycobacterium abscessus contamination of
unopened vial of Hallmark Labs' labeled
product distributed by Phyne Pharmaceuticals
and epidemiological data collected by CDC
correlating the use of this product with
Mycobacterium abscesses at the site of
injection.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT SoloPak Gentamicin Sulfate Injection USP, 40
mg/ml, in 2 ml and 20 ml vials, Rx
aminoglycoside antibiotic. Recall #D-007-7.
CODE Catalog #01402, Lot #951150; Catalog #01420,
Lot #950957.
MANUFACTURER SoloPak Pharmaceuticals, Inc., Elk Grove
Village, Illinois.
RECALLED BY Manufacturer, by letter dated September 26,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 256,050 vials were distributed; firm estimated
that 13 percent of the product remained on the
market at time of recall.
REASON Product may contain endotoxins.

-3-_______________
PRODUCT SoloPak Heparin Lock Flush Solution, USP, Rx,
preservative free, 100 USP units/ml, in 1 ml
pre-filled syringes, for maintenance of
patency of indwelling therapy or blood
sampling, and not to be used for anticoagulant
therapy. Recall #D-008-7.
CODE Catalog #10781, Lot #96D026F; Catalog #11871,
Lot 96D026B; Catalog #03702, Lot #96D026C.
MANUFACTURER SoloPak Medical Products, Inc., Franklin Park,
Illinois.
RECALLED BY SoloPak Medical Products, Inc., Elk Grove
Village, Illinois, by letter dated September
26, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 41,240 syringes were distributed; firm
estimated that 12 percent of the syringes
remained on market at time of recall
initiation.
REASON Lack of adequate assurance of sterility.

_______________
PRODUCT Kanamycin Sulfate Injection USP, Rx, 250
mg/ml, in 2 ml single dose vials, Rx
aminoglycoside antibiotic for I.V. or
intramuscular injection. Recall #D-009-7.
CODE Lot #950429.
MANUFACTURER SoloPak Pharmaceuticals, Inc., Elk Grove
Village, Illinois.
RECALLED BY Manufacturer, by letter dated September 26,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 18,360 vials were distributed; firm estimated
that 10 percent of the product remained on
market at time of recall initiation.
REASON Lack of adequate assurance of sterility.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Levothroid Tablets (Levothyroxine sodium) USP,
75 mcg, in bottles of 100, prescribed as a
thyroid replacement therapy.
Recall #D-005-7.
CODE Lot #69515 EXP 1/97.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati,
Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis,
Missouri (distributor), by telephone on or
about April 18, 1996, followed by letter (if
requested) dated April 23, 1996. Firm-
initiated recall complete.

-4-DISTRIBUTION Nationwide.
QUANTITY 13,768 bottles were distributed.
REASON 50 mcg tablets may have been packaged into
bottles labeled as 75 mcg.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-335-6.
CODE Unit numbers: 50F11463, 50F11465, 50F11467,
50F11468, 50F11470, 50F11482, 50F11485,
50F11495, 50F11496, 50F11497, 50F11498,
50F11499, 50F11501, 50F11506, 50G77082,
50G77085, 50G77086, 50G77087, 50G77088,
50G77089, 50G77092, 50G77093, 50G77095,
50G77096, 50G77097, 50G77098, 50G77099,
50G77100, 50G77101, 50G77103, 50G77104,
50G77105, 50G77106, 50G77109, 50G77113,
50G77114, 50G77115, 50G77116, 50G77117,
50G77120, 50G77147, 50G77149, 50G77154,
50G77156, 50G77157, 50G77158, 50G77159,
50G77163, 50G77164, 50G77165, 50G77166,
50G77170, 50G77173, 50G77178, 50G77186,
50G77187, 80G77188, 50G77189, 50G77190,
50G77191, 50G77193, 50G77197, 50G77199,
50G77215, 50G77216, 50G77217, 50G77220,
50G77222, 50G77225, 50G77227, 50G77229,
50G77242, 50G77244, 50G77249, 50G77257,
50G77258, 50G77259, 50G77261, 50G77264,
50G77265, 50G77266, 50G76926, 50G76964,
50G77004, 50G77027.
MANUFACTURER American Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone on November 21,
1994, and by letter dated December 1, 1994.
Firm-initiated recall complete.
DISTRIBUTION Idaho and Ohio.
QUANTITY 85 units were distributed.
REASON Blood products were labeled as CP2D platelets
instead of CPD platelets.

_______________
PRODUCT (a) Red blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-665/667-6.
CODE Unit numbers: (a) 136367, 138291, BB139962,
BB142162; (b) 136367, BB142162; (c) 138291.
MANUFACTURER Blood Bank of Alaska. Anchorage, Alaska.
RECALLED BY Manufacturer, by letter dated September 7,
1995. Firm-initiated recall complete.
DISTRIBUTION Alaska, California.

-5-QUANTITY (a) 4 units; (b) 2 units; (c) 1 unit was
distributed.
REASON Blood products were collected from a donor
with a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF;
(c) Recovered Plasma. Recall #B-672/674-6.
CODE Unit #06GE90589.
MANUFACTURER American Red Cross Blood Services, Los
Angeles, California.
RECALLED BY Manufacturer, (a&b) by letter dated August 14,
1986; (c) by letter dated December 10, 1992.
Firm-initiated recall complete.
DISTRIBUTION California and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
hepatitis B surface antigen (HBsAg), but were
collected from a donor who previously reported
a history of hepatitis.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-682/683-6.
CODE Unit numbers: (a) 53FH51353; (b) 53FH45685.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated February 28,
1996 and March 20, 1996. Firm-initiated
recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-684-6.
CODE Unit #17KK06994.
MANUFACTURER North Central Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by letter dated January 26,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-686-6.
CODE Unit #17KL01266.
MANUFACTURER North Central Blood Services, St. Paul,
Minnesota.
-6-RECALLED BY Manufacturer, by letter dated January 17,
1996. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.

_______________
PRODUCT Platelets, Pheresis. Recall #B-697-6.
CODE Unit #0006381.
MANUFACTURER The Community Blood Center, Inc., Appleton,
Wisconsin.
RECALLED BY letter dated July 28, 1995. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT Cryoprecipitated AHF. Recall #B-698-6.
CODE Unit #6078862.
MANUFACTURER The Community Blood Center, Inc., Appleton,
Wisconsin.
RECALLED BY Manufacturer, by telephone on May 3, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood with an extended collection time.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells, Leukocytes Removed by
Filtration. Recall #B-451-6.
CODE Unit #29133-8643.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on March 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at an unacceptable
temperature.

_______________
PRODUCT Recovered Plasma. Recall #B-668-6.
CODE Unit numbers: 136367, BB139962, BB142162.
MANUFACTURER Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY Manufacturer, by letter dated September 7,
1995. Firm-initiated recall complete.

-7-DISTRIBUTION Alaska and California.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor
with a history of cancer.

_______________
PRODUCT Recovered Plasma. Recall #B-685-6.
CODE Unit #17KK06994.
MANUFACTURER North Central Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by telephone January 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product was collected from a donor who
reported a history of cancer.

_______________
PRODUCT Recovered Plasma. Recall #B-687-6.
CODE Unit #17KL01266.
MANUFACTURER North Central Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by telephone on January 11,
1996. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.

_______________
PRODUCT Irradiated Red Blood Cells. Recall #B-695-6.
CODE Unit numbers: 6076076, 6076092, 6076101.
MANUFACTURER The Community Blood Center, Inc., Appleton,
Wisconsin.
RECALLED BY Manufacturer, by telephone on February 12,
1996. Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 3 units were distributed.
REASON Blood products were labeled with an extended
expiration date.

_______________
PRODUCT Irradiated Red Blood Cells. Recall #B-696-6.
CODE Unit #6073417.
MANUFACTURER The Community Blood Center, Inc., Appleton,
Wisconsin.
RECALLED BY Manufacturer, by telephone on November 6,
1995. Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

-8-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Beam Limiting Device Type Number 9896 010
00011, diagnostic x-ray system.
Recall #Z-1163-6.
CODE None.
MANUFACTURER Philips Medical Systems, Shelton, Connecticut.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan September 30, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4 units were distributed.
REASON Noncompliance with the federal performance
standard for diagnostic x-ray systems and
their major components in that these products
are uncertified and intended only for use
outside the United States.

_______________
PRODUCT Genesis Dual Display Patient Monitors.
Recall #Z-002/004-7.
CODE (a) M2350A Component Central Monitor,
Monochrome: Option A10 - 10 wave capability
Option A12 - 12 wave capability
Option H75 - 14" monochrome display with 6 bed
keys
Option H76 - 14" monochrome display with 8 bed
keys
(b) M2360A Component Central Monitor, Color:
Option A10 - 10 wave capability
Option A12 - 12 wave capability
Option H75 - 14" color display with 6 bed keys
Option H76 - 14" color display with 8 bed keys
(c) M2305AU Upgrade Kits:
Option H84 - 14" color display and interface
with 8 bed keys
Option H85 - 14" color display and interface
with 6 bed keys
Option H86 - 14" monochrome display and
interface with 8 bed keys
Option H87 - 14" color display and interface
with 6 bed keys.
MANUFACTURER Hewlett Packard Company, Medical Products
Group, Andover, Massachusetts.
RECALLED BY Manufacturer, by letter July 19, 1996,
followed by visit. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,890 units were distributed; 385 units were
recovered/corrected at time of field
correction initiation.

-9-REASON The devices did not alarm at the central
station, due to a system lockup which caused a
loss of keyboard input and audible alarm.

_______________
PRODUCT Permobil Powered Wheelchair Model Chairman
Corpus Backrest Hinges. Recall #Z-005-7.
CODE Serial numbers 40111 through 42572.
MANUFACTURER Permobil, AB, Timra, Sweden.
RECALLED BY Permobil, Inc., Woburn, Massachusetts, by
telephone in February 1996. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 635 wheelchairs were imported; 58 had been
corrected at time of field correction
initiation.
REASON The backrest welds were subject to failures
and cracks.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Vitros Na+ Slides, Catalog No. 162 7504, for
use with the Vitros Chemistry Systems to
quantitatively measure sodium in serum, plasma
and urine. Recall #Z-006-7.
CODE Lot Numbers 42XX-0272-XXXX, the number 42 is
the chemistry identification number for
sodium. The coating number is the middle 4
digits of the 12 digit lot number. The
affected products are coatings 0272 and higher
with expiration dates on or after 31 August
1996.
MANUFACTURER Johnson & Johnson Clinical Diagnostics,
Rochester, New York.
RECALLED BY Manufacturer, by letter dated August 16, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,845,782 slide cartridges were distributed;
firm estimated that 500,000 cartridges
remained on the market at time of recall
initiation.
REASON The sodium results drift out of specifications
when the slides are stored on the analyzer
longer than 10 days.

-10-

END OF ENFORCEMENT REPORT FOR OCTOBER 16, 1996. BLANK PAGES MAY FOLLOW.

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