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.
June 10, 1998 98-23
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ================
_______________
PRODUCT Pepperoncini, packed under the Country Day
brand in 12 oz., 16 oz., and 1 gallon glass
jars and also in 1 gallon plastic containers,
packed under the Casa Visco brand in 32 oz.
glass jars.
Recall #F-500-8.
CODE None. All product of the involved sizes that do
not have sodium bisulfite.
MANUFACTURER William Kleinberger and Sons, Inc., Scranton,
Pennsylvania.
RECALLED BY Manufacturer, by press release on March 28, 1998,
by telephone and letters starting on March 28,
1998. Firm-initiated recall comlpete.
DISTRIBUTION New York, New Jersey, Pennsylvania, Vermont,
Connecticut, New Hampshire.
QUANTITY Firm estimated that less than 500 cases under the
Country Day label remained on the market at time
of recall initiation. The quantity for the Casa
Visco brand is undetermined.
REASON The product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===============
_______________
PRODUCT Tortilla Chips: a) Santitas brand white corn
Tortilla Chips in 14 oz. packages with a white
background
b) Santitas brand regular Tortilla Chips in 14 oz.
packages with a yellow background.
Recall #F-497/498-8.
CODE a) Sell by date JUN 30 and manufacturing codes
149131 and 149232; b) Sell by date JUN 30 and
manufacturing code 249337.
MANUFACTURER Frito-Lay, Inc., Inc., Modesto, California.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by visit on
4/29/98. Firm-initiated recall ongoing.
DISTRIBUTION Calforina.
QUANTITY 25,200 bags were distributed.
REASON Products contain undeclared dairy ingredients,
an undeclared soy ingredient and undeclared
FD&C Yellow No. 5.
_______________
PRODUCT Paradize Cotton Candy, net weight 3 ounces
packaged in flexible plastic, product of Canada.
Recall #F-499-8.
CODE None. All product.
MANUFACTURER Candy King Corporation, Scarborough, Ontario,
Canada.
RECALLED BY Cumberland Farms, Inc., Canton, Massachusetts,
by memorandum on April 22, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Delaware, Florida, Massachusetts, Maine, New
Hampshire, New Jersey, New York, Pennsylvania,
Rhode Island, Vermont, Connecticut.
QUANTITY 1,471 (24 units per case) were distributed.
REASON The product contains the following undeclared
FD&C colors: Yellow No. 5, Yellow No. 6,
Red No. 3, Red No. 40, Blue No. 1, and Green
No. 3.
_______________
UPDATE Frozen Yellowfin Tuna, Recall #F-332-8, which
appeared in the April 29, 1998, Enforcement Report
should read:
MANUFACTURER: Trident Seafoods Corporation, Bellingham,
Washington.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==============
_______________
PRODUCT New Thomas' New York Bagels, pre-sliced blueberry
bagels, net weight 22 ounces (623g).
Recall #F-496-8.
CODE Pull Dates/Fresh Product:
(1) Greenwich Distribution Market Area:
4 Mar, 5 Mar, 6 Mar, 8 Mar, 9 Mar, 10 Mar, 12 Mar,
13 Mar.
(2) Southeast Distribution Market Area:
3 Mar, 5 Mar, 6 Mar, 8 Mar, 9 Mar, 10 Mar, 12 Mar,
13 Mar.
Code Dates/Frozen Products- Denver Distribution
locations: 240303 (3/3), 260305 (3/5), 270306
(3/6), 280307 (3/7), 020309 (3/9), 030310 (3/10),
050312 (3/13), 060313 (3/13), 070314 (3/14),
090316 (3/14), 100317 (3/17).
MANUFACTURER Contract Manufacturers- Fleischer's Bagels, Inc.,
Macedon, NY-Bagel Master, Beltsville, MD.- Crispy
Bagels Company, Inc., Baltimore, MD.- Maple Leaf
Bakery, Franklin Park, IL.-Bagel Works, Charlotte,
NC.
RECALLED BY Best Foods Baking Company, Bay Shore, New York, by
telephone on March 2, 1998. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 46,268 packages (Greenwich), 19,827 packages
(Southeast), 162,432 packages were distributed.
REASON Product contains undeclared colors (Red No. 40 and
Blue No. 1).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=============
_______________
PRODUCT Anzemet(R) Injection (Dolasetron Mesylate), 12.5
mg (20mg/mL), in 0.625 mL ampuls, Rx anti-nauseant
and anti-emetic agent. NDC #0088-1208-65.
Recall #D-169-8.
CODE Lot #73007091 EXP 5/99.
MANUFACTURER Ben Venue Laboratories, Bedford, Ohio. Contract
Manufacture
RECALLED BY Hoechst Marion Roussel, Inc., Cincinnati, Ohio, by
letter on May 14, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 31,506 ampules were distributed; firm estimated
that 30 percent of product (9,452 ampules)
remained on market at time of recall initiation.
REASON Precipitate formation (dolasetron sulfate
crystals) due to inadequate ampule washing.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==============
_______________
PRODUCT Tincoben(R) Topical Protective Tincture (Benzoin,
Aloe, Tolu Balsam and Storax), in 4 fluid ounce
bottles, OTC, indicated for use as a topical
protective. NDC #0496-0542-04.
Recall #D-168-6.
CODE Lot #57-035 EXP 2/99.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale, Michigan.
RECALLED BY Manufacturer, by letter on April 23, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13,313 bottles were distributed.
REASON Stability failure (below specification) for
non-volatile residue.
_______________
PRODUCT BullFrog Quick Gel SPF 18 Sunblock, in 4 ounce
bottles. Recall #D-170-8.
CODE Lot #97K2.
MANUFACTURER Chattem, Inc., Chattanooga, Tennessee.
RECALLED BY Manufacturer, by letter dated May 8, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 20,697 units were distributed.
REASON Mislabeling - The back panel label incorrectly
declares the product as SPF36.
_______________
PRODUCT SUPAC Analgesic Tablets (Acetaminophen 160
mg/Aspirin 230 mg/caffeine 33 mg), in 100 and
1,000 tablet bottles. Recall #D-171-8.
CODE Lot numbers: 5F03, 5H01, 5L06.
MANUFACTURER Mission Pharmacal Company, Boerne, Texas.
RECALLED BY Manufacturer.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2533/100 tablets and 1133/1000 Tablets bottles
were distributed.
REASON Stability - Data does not support labeled
expiration date (salicylic acid value).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ===========
_______________
PRODUCT Red Blood Cells. Recall #B-948-8.
CODE Unit #22GP79759.
MANUFACTURER American Red Cross - Penn Jersey Region,
Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by fax on November 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was mislabeled for injectable use
instead of for non-injectable use.
_______________
PRODUCT LeukoNet Pre-Storage Leukoreduction Filtration
System (Leukocyte Reduction Filter w/Attached
Storage Bag for Red Blood Cells).
Recall #B-1077-8.
CODE Lot # 72461-73511's, Product Mfg. from
9/3/97-12/17/97.
MANUFACTURER HemaSure, Inc., Marlborough, Massachusetts.
RECALLED BY Manufacturer, by fax or by telephone on January 6,
1998, and by letter on April 20, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 60,796 filters were distributed.
REASON LeukoNet, leukocyte reduction filters have been
implicated with numerous reports of adverse
transfusion reactions.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1124/1125-8.
CODE Unit #17KL42402.
MANUFACTURER American Red Cross Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by letter dated October 13, 1997.,
and by fax on October 14, 1997. Firm-initiated
recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
reported to engage in high risk behavior, were not
quarantined, and were distributed after receipt of
the information.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1134/1135-8.
CODE Unit #24KE10855.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letter dated April 23, 1997 and
May 23, 1997. Firm-initiated recall complete.
DISTRIBUTION Puerto Rico and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood product was collected from a donor with a
history of exposure to hepatitis.
_______________
PRODUCT Red Blood Cells. Recall #B-1155-8.
CODE Unit #32KH50468.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by telephone on August 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had
no hematocrit or hemoglobin check recorded during
screening.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1156-8.
CODE Split units 32KP05280 and 32KP05296.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated November 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin and Illinois.
QUANTITY 2 units were distributed.
REASON Blood products tested negative for CMV, but were
collected from donors who previously tested CMV
positive.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1157/1158-8.
CODE Unit #32KF31973.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by telephone on September 5, 1997,
and by letter dated September 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit of each component was distributed.
REASON blood products tested negative for CMV, but were
collected from a donor who previously tested CMV
positive.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1159-8.
CODE Unit #32GP04805.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by telephone on August 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.
_______________
PRODUCT Red Blood Cells. Recall #B-1161-8.
CODE Unit #32FC15854.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by telephone on November 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody to
the human T-lymphotropic virus 1 (anti-HTLV-1),
but was collected from a donor who previously
tested repeatedly reactive for anti-HTLV-1,
Western blot indeterminate.
_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF.
Recall #B-1162/1163-8.
CODE Unit #7939728.
MANUFACTURER New Jersey Blood Services, New Brunswick, New
Jersey.
RECALLED BY New York Blood Services, New York, New York, by
telephone on March 30, 1998, and by letter on
April 20, 1998. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were prepared from an overweight
whole blood unit.
_______________
PRODUCT Platelets. Recall #B-1176-8.
CODE Unit #H20462.
MANUFACTURER Regional Health Resource Center, Community Blood
Services of Illinois, Urbana, Illinois.
RECALLED BY Manufacturer, by telephone on March 16, 1998, and
by letter dated March 19, 1998. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking a
drug containing aspirin.
_______________
PRODUCT Red Blood Cells. Recall #B-1180-8.
CODE Unit #36R56381.
MANUFACTURER American Red Cross Blood Services, Columbia, South
Carolina.
RECALLED BY Manufacturer, by telephone on September 16, 1997,
and by letter dated October 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Unit of platelets was implicated in a transfusion
reaction, was found to be contaminated with
Chyrseomonas luteola. Corresponding blood product
was distributed.
_______________
PRODUCT Autologous Red Blood Cells. Recall #B-1181-8.
CODE Unit #KP52136.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on April 15, 1998.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Failure to quarantine an autologous blood product
due to incomplete testing results, which
subsequently tested repeatedly reactive for the
antibody to the hepatitis B core antigen
(anti-Hbc), and was distributed without a
biohazard label.
_______________
PRODUCT a) Whole Blood; b) Red Blood Cells; c) Plasma; d)
Recovered Plasma; e) Red Blood Cells, for further
manufacturing. Recall #B-1182/1186-8.
CODE Unit numbers: a) 53KW25191; b) 53KW19735,
53GN22009; c) 53GN22009; d) 53KE12896, 53KW19735,
53KR21793; e) 53KR21793.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated March 25, 1998, or
April 7, 1998. Firm-initiated recall complete.
DISTRIBUTION Maryland, Virginia, District of Columbia,
California, Switzerland.
QUANTITY a) 1 unit; b) 2 units; c) 1 units; d) 3 unit e) 1
unit was distributed.
REASON Blood products tested negative for the antibody to
the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from donors who
previously tested initially reactive for
anti-HIV-1, with no repeat testing or Western
blots performed.
_______________
PRODUCT a) Whole Blood; b) Red Blood Cells; c) Recovered
Plasma; d) Recovered Plasma, for manufacture of
non-injectables. Recall #B-1193/1196-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letter dated February 24, 1998,
March 6 or 9, 1998, or February 25, 1998.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Switzerland.
QUANTITY a) 2 units; b) 133 units; c) 107 units; d) 11
units were distributed.
REASON Blood products were tested for syphilis using
outdated plasma samples.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Red
Blood for Manufacturing use; d) Recovered Plasma.
Recall #B-1202/1205-8.
CODE Unit numbers: 40FY01723, 40GH00704, 40FY03548,
40GS09822, 40FY04788, 40FY05210, 40FY05694,
40GS92799, 40FY01132, 40FY01394, 40FY06249,
40GC09199, 40GT00727, 40FY11856
b) 40GS09822
c) 40FY02019, 40FY02428, 40FY03887, 40GS95051,
40FY06754, 40GC08334
d) 40FY01723, 40FY02019, 40FY02428, 40GH00704,
40FY03548, 40FY03887, 40FY04788, 40FY05210,
40FY05694, 40GS92799, 40GS95051, 40FY01132,
40FY01394, 40FY06249, 40FY06754, 40GC08334,
40GC09199, 40GT00727, 40FY11856.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated September 1, 1997,
and by letters on November 6, 1997, October 1,
1997, February 7, 1998, and March 10, 1998.
Firm-initiated recall complete.
DISTRIBUTION Alabama, Connecticut, Illinois, Iowa, Michigan,
Pennsylvania, California.
QUANTITY a) 14 units; b) 1 unit; c) 6 units; d) 19 units
were distributed.
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus type
1 (HIV-1), but were collected from a donor who
previously tested repeatedly reactive for the
antibody, and was subjected to additional
retesting.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ==========
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-1145-8.
CODE Unit #KM34110, KK40990, KH68160.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on August 1, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 3 units were distributed.
REASON Expired blood products were labeled with extended
expiration dates.
_______________
PRODUCT Red Blood Cells. Recall #B-1151-8.
CODE Unit numbers: 53FM20561, 53R2856, 53KC04693,
53Y70230, 53G20724.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland
RECALLED BY Manufacturer, by telephone on August 5, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 5 units were distributed.
REASON Blood products were leukodepleted by filtration
greater than 7 days past the day of collection.
_______________
PRODUCT Red blood Cells. Recall #B-1153-8.
CODE Unit numbers: 36Y53857, 36Y53859, 36Y53862,
36Y53864, 36Y53868, 36Y53870, 36Y53871, 36Y53872,
36Y53873 and 36Y53874.
MANUFACTURER American Red Cross Blood Services, Columbia, South
Carolina.
RECALLED BY Manufacturer, by letters dated April 9 and 10,
1996. Firm-initiated recall complete.
DISTRIBUTION Georgia and South Carolina.
QUANTITY 10 units were distributed.
REASON Blood products were labeled with extended
expiration dates.
_______________
PRODUCT Red Blood Cells. Recall #B-1160-8.
CODE Unit #32KM05820.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by telephone on September 23, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT Platelets. Recall #B-1175-8.
CODE Unit #32KG63341.
MANUFACTURER American Red Cross National Testing laboratory,
Eagan, Minnesota (testing laboratory).
RECALLED BY American Red Cross Blood Services, Madison,
Wisconsin, by telephone on or about July 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was tested for antibody to the human
T-lymphotropic virus 1 (anti-HTLV-1), in a manner
inconsistent with the manufacturers test kit
instructions.
_______________
PRODUCT Red Blood Cells. Recall #B-1154-8.
CODE Unit #28LE15323.
MANUFACTURER American Red Cross Blood Services, Savannah,
Georgia.
RECALLED BY Manufacturer. Consignee was contacted on November
17, 1997 to determine the final disposition of the
unit. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product had an insufficient red blood cell
recovery after leukodepletion.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =============
_______________
PRODUCT Manan Prostate Uni-Lock Needle, 18 GA.RW x 20.8
CM, a sterile, single-use Rx two-part needle
designed to prevent the prostate from rotating
during prostate seeding procedures.
Recall #Z-599-8.
CODE Catalog #PLUS1820, All lots.
MANUFACTURER Manan Medical Products, Inc., Northbrook,
Illinois.
RECALLED BY Manufacturer, by telephone on May 26-28, 1998,
followed by letter on June 1, 1998.
Firm-initiated recall complete.
DISTRIBUTION Florida, Georgia, Texas, Kentucky, Maryland,
Washington state, California, Wisconsin, Alabama,
New York, Kansas.
QUANTITY 1,700 units were distributed; firm estimated that
10 percent of the product remained on market at
time of recall initiation.
REASON The plastic body of the needle may come open at
the weld line, increasing the risk of a
malfunction.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ==============
_______________
PRODUCT Unimar Aspirette Endocervical Aspirator, Sterile,
length: 23.5 cm, O.D. size: 3.1 mm, used for
aspiration of endocervical mucus and post-coital
content. Recall #Z-586-8.
CODE Product #8700, Lot #711211, EXP 11-00.
MANUFACTURER Cooper Surgical, Shelton, Connecticut.
RECALLED BY Manufacturer, by telephone the week of March 30,
1998. Firm-initiated recall complete.
DISTRIBUTION Indiana, Maryland, Tennessee, Texas, Wisconsin.
QUANTITY 261 units were distributed.
REASON Sterility of device is compromised due to voids in
the package seal.
_______________
PRODUCT ZOLL Radiolucent StatPadz Electrodes, intended for
use in defibrillation, non invasive pacing,
cardioversion and ECG monitoring in conjunction
with ZOLL defibrillator/pacer equipment.
Recall #Z-587-8.
CODE Lot #1198 EXP 14 SEP 98.
MANUFACTURER Bio-Detek Inc., Pawtucket, Rhode Island.
RECALLED BY Manufacturer, by letter on April 30, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Uruguay.
QUANTITY 600 pairs were distributed.
REASON Electrode pads were unable to conduct
defibrillation.
MEDICAL DEVICE SAFETY ALERT: ====================================
_______________
PRODUCT Hemodialysis Machine, Model 2008H, used in clinics
to treat patients with kidney deficiency.
Safety Alert #N-006-8.
CODE All serial numbers.
MANUFACTURER Fresenius Medical Care, Walnut Creek, California.
ALERTED BY Manufacturer, by letter dated April 27, 1998.
DISTRIBUTION Nationwide, Canada, Mexico, Caribbean.
QUANTITY 23,000 units were distributed.
REASON On rear occaisions the machine may spontaneously
shut down during mid-treatment without an audible
alarm.
END OF ENFORCEMENT REPORT FOR JUNE 10, 1998. BLANK PAGES MAY
FOLLOW.
####
End of Enforcement Report for
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