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 12, 1997 97-46
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Golden Lion brand Dried Fish (Golden
Butterfish), in flexible plastic packages.
Recall #F-086-8.
CODE None.
MANUFACTURER Hua Feng Food Company, Ltd., Shuibu Taishan
City, China.
RECALLED BY Blooming Import company, Brooklyn, New York
(importer/distributor), by letter on May 7,
1997. Completed recall resulted from sample
analysis and follow-up by the New York
Department of Agriculture and Markets.
DISTRIBUTION New York and Illinois.
QUANTITY 13 cases were distributed.
REASON Product has the potential to support the
growth of Clostridium botulin toxin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Blueberry Deluxe English Muffins in 14 ounce
plastic sleeve, 4 muffins per package with 12
packages per case. Recall #F-073-8.
CODE External Case Code Tab Closure Code on Bag
Sell by 05/28/98 19017183A and B
Sell by 05/29/98 19017183B
Sell by 06/19/98 19017205B
Sell by 06/20/98 19017205B
Sell by 07/01/98 19017217A and B
Sell by 07/02/98 19017217B.
MANUFACTURER Wolferman's, Inc., Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on August 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 703 cases were distributed.
REASON The product contains undeclared soy protein.
_______________
PRODUCT Ruffles brand Potato Chips, in 1-3/4 ounce
bags. Recall #F-074-8.
CODE Manufacturing code 136115, lot #OCT07.
MANUFACTURER Frito-Lay, Inc., Jackson, Mississippi.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by fax on
August 13, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Arkansas, Louisiana, Mississippi, Tennessee.
QUANTITY 214 cases were distributed.
REASON The product contains undeclared corn syrup
solids, hydrolyzed corn, soy, and wheat
gluten, and monosodium glutamate.
_______________
PRODUCT Vitamin Mineral Premixes:
a) Vitamin Premix for Performance/Tiger Bar
b) Vitamin/Mineral Premix for Hi-Protein Bar
c) Vitamin/Mineral Premix.
Recall #F-080/082-8.
CODE Lot numbers: a) 706045; b) 706078; c) 705228.
MANUFACTURER Fortitech, Inc., Schenectady, New York.
RECALLED BY Manufacturer, by telephone on July 24, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Idaho and Utah.
QUANTITY 20/100-lb. drums of FT971050(lot 706045),
39/100-lb. drums + 1/70-lb. drum of
FT962258(lot 706078), 4/50-kg. drums of
FT971332, (lot 705228) were distributed.
REASON The ferrous fumarate used in the manufacture
of these premixes contained excessive levels
of lead.
RECALLS AND FIELD CORRECTIONS: FOODS --CLASS III ============
_______________
PRODUCT Hershey Sweet Escapes: a) Sweet Escapes
Triple Chocolate Wafers, item #05115, packaged
in 10.5 ounce bags for Halloween
-2-
b) Sweet Escapes Caramel & Peanut Butter
Crispy Bar in 10.5 ounce bags for Halloween.
Recall #F-078/079-8.
CODE a) 67AAP, 68AAP, 68EAP, 70JAP, 67KAP, 68ABP,
68GAP, 70JBP, 67PAP, 68DAP, 68GBP, 70KAP,
67PBP, 68DBP, 68HAP, 70KBP, 70RBP
b) 67GAP, 67MBP, 67NAP, 67GBP, 67MAP.
MANUFACTURER Hershey Chocolate of Virginia, Stuarts Draft,
Virginia.
RECALLED BY Hershey Chocolate USA, Hershey, Pennsylvania,
by letter on September 29, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION a) Indiana; b) Florida, Illinois, Louisiana,
Oklahoma, Tennessee.
QUANTITY a) 6,676 cases; b) 1,184 cases were
distributed.
REASON Short weight. The products had either 2% or
6.6% less weight than declared on the label.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============
_______________
PRODUCT Oxygen, Compressed, USP, in high pressure
cylinders, size C, D, E, and M6.
Recall #D-030-8.
CODE AOG04, AOG11, AOG18, AOG25, A1R07, JOL07,
JOL14, JOL28, JON30, MOM19, OOT06, S1P08,
S1P15, S1P22, S1P29.
MANUFACTURER American Access and Mobility, Inc., doing
business as Mercy Medical Equipment and Oxygen
Company, West Seneca, New York.
RECALLED BY Manufacturer, by telephone on October 16,
1997. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 690 units were distributed; firm estimated
that 36 units were still in possession of
customers as of 10/28/97.
REASON Current good manufacturing practice
deficiencies including but not limited to
failure to document testing prior to release.
_______________
PRODUCT Oxygen USP, in aluminum high pressure
cylinders, M-6, M-7, and M-9.
Recall #D-032-8.
CODE 97055XX through 97122XX (Victor Medical) and
Sherwood Valve codes 40-96, 46-96, and 01-97.
MANUFACTURER Victor Medical, a Thermadyne Company, Denton,
Texas.
-3-
RECALLED BY Victor Medical, a Thermadyne Company, St.
Louis, Missouri, by telephone on May 5, 1997,
by fax dated June 12, 1997, and by letters
dated July 18 and 25, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Chlorine odors.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Phenadex Pediatric Cough & Cold Drops,
Phenylpropanolamine Hydrochloride 6.25
mg/Guaifensin 50 mg/Dextromethorphan
Hydrobromide 5 mg, in 1 fluid ounce (30 ml)
units, for children 2 to under 6, OTC used for
the temporary relief of nasal congestion.
Recall #D-031-8.
CODE Lot #VK6563 EXP 1/99.
MANUFACTURER Alpharma, U.S. Pharmaceuticals Division,
Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated October 16,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 8,648 units were distributed; firm estimated
that 1,000 units remained on market at time of
recall initiation.
REASON Failure to apply tamper evident seals.
RECALLS AND FIELD CORRECTIONS -- BIOLOGICS -- CLASS II ======
_______________
PRODUCT Platelet Pheresis. Recall #B-064-8.
CODE Units numbers: 04FP 36845A, 04FP 36845B,
04FP 36876A, 04FP 36876B, 04GP 33074A,
04GP 33074B, 04FP 36857A, 04FP 36857B.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letter dated December 18,
1996. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 8 units were distributed.
REASON Blood product was stored in insufficient
volume of plasma
_______________
PRODUCT Platelets, Pheresis. Recall #B-084-8.
CODE Unit Numbers: Unit Numbers
04KE 04943A 04KE 04943B
04P 35396A 04P 35396B
04P 35453A 04P 35453B
04FP 36732A 04FP 36732B
04FP 36778A 04FP 36778B
-4-
04FP 36779A 04FP 36779B
04GP 33039A 04GP 33039B
04LP 27564A 04LP 27564B
04P 35455B.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letter dated November 29,
1996. Firm-initiated recall complete.
DISTRIBUTION Massachusetts and Vermont.
QUANTITY 17 units were distributed.
REASON Blood products contained an insufficient
amount of plasma.
_______________
PRODUCT Platelets, Pheresis. Recall #B-085-8.
CODE Unit #04LM54684.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated May 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.,
REASON Blood product was collected in a manner that
could compromise the sterility of the product.
_______________
PRODUCT Red Blood Cells. Recall #B-086-8.
CODE Unit #04FK58010.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated May 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maine.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
was taking the drug Amantadine.
_______________
PRODUCT a) Whole Blood; b) Red Blood Cells;
c) Platelets; d) Recovered Plasma.
Recall #B-087/090-8.
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, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by telephone on November 4,
1996, followed by letter dated November 20,
1996. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maine, Vermont, New Hampshire,
New York, California, New York.
QUANTITY a) 1 unit; b) 38 units; c) 7 units; d) 6 units
were distributed.
-5-
REASON Blood products were collected in a manner that
could compromise the sterility of the
products.
_______________
PRODUCT Source Plasma. Recall #B-092-8.
CODE Unit #G10745-134.
MANUFACTURER American Biologics, Inc., Waco, Texas.
RECALLED BY Manufacturer, by letter on July 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was untested for Hepatitis B
surface antigen (HBsAg), and the antibodies to
the human immunodeficiency virus type «
(anti-HIV-1/2), Hepatitis C virus encoded
antigen (anti-HCV), Hepatitis B core antigen
(anti-HBc), and syphilis.
_______________
PRODUCT Platelets. Recall #B-094-8.
CODE Unit #3549364.
MANUFACTURER Lifesource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated October 15,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for CMV, but was
collected from a donor who previously tested
CMV positive.
_______________
PRODUCT Granulocytes - Platelets Pheresis.
Recall #B-097-8.
CODE Unit #17S16851.
MANUFACTURER American Red Cross, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter dated July 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody
to the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor
who previously tested repeatedly reactive for
anti-HIV-1.
_______________
PRODUCT Platelets, Pheresis. Recall #B-100-8.
CODE Unit 16KF11347 (Split unit).
MANUFACTURER American Red Cross Blood Services, Columbus,
Ohio.
RECALLED BY Manufacturer, by letter dated August 29, 1997.
Firm-initiated recall complete.
-6-
DISTRIBUTION Ohio.
QUANTITY 1 split unit was distributed.
REASON Blood product was collected in a manner that
could compromise the sterility of the product.
_______________
PRODUCT Plasma, Pheresis. Recall #B-101-8.
CODE Unit #53LP15406.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on April 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of
Platelets, Pheresis, that was implicated in a
transfusion reaction and was positive for
coagulase negative Staphylococcus and
Propionibacterium sp.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-102/103-8.
CODE Unit numbers: a) 53GL84865, 53T33065,
53G03980, 53GN84652, 53FX45635
b) 53GL84865, 53T33065, 53GN84652,
53FX45635.
MANUFACTURER American Red Cross Blood Services,
Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated May 1, 1997,
followed by letters to non-respondents on June
6 or 9, 1997. Firm-initiated recall complete.
DISTRIBUTION Maryland, District of Columbia,
Massachusetts.
QUANTITY a) 5 units; b) 4 units were distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-105-8.
CODE Unit #42F38446.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated September 8,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.
-7-
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-107/108-8.
CODE Unit #21FT11370.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated March 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
was deferred for receiving a tattoo within 12
months of donation.
_______________
PRODUCT Red Blood Cells. Recall #B-109-8.
CODE Unit #94FF 94133.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter May 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maine.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
taking the drug Ridaura.
_______________
PRODUCT a) Red Blood Cells; b)
Recovered Plasma.
Recall #B-112/113-8.
CODE Unit numbers: a) 17FW07653, 17FW08291;
b) 17LX00087.
MANUFACTURER American Red Cross, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter dated May 24, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION California and Wisconsin.
QUANTITY a) 2 units; b) 1 unit was distributed.
REASON Blood products were collected from a donor
living with a son who tested positive for
hepatitis C.
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma. Recall #B-114/116-8.
CODE Unit #17KR11297.
MANUFACTURER American Red Cross, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter dated May 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION Florida and Minnesota.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a tattoo within twelve months of
donation.
-8-
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-117/118-8.
CODE Unit #4871169.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter dated August 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of body piercing within twelve
months of donation.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Platelets, Pheresis. Recall #B-046-8.
CODE Unit numbers: 04P33878, 04P33881, 04LM51484.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated April 9, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maine.
QUANTITY 3 units were distributed.
REASON Blood products were shipped at an unacceptable
temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-091-8.
CODE Unit numbers: 18E94191 and 18R82097
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone and letter on March
6, 1997. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 2 units.
REASON Blood products, for which temperature after
shipment was not recorded upon receipt, were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-096-8.
CODE Unit #04KL76401.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated August 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product was shipped at an unacceptable
temperature.
-9-
_______________
PRODUCT Red Blood Cells. Recall #B-098-8.
CODE Unit numbers: 04KK46616, 04KK46601, 04V34407.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated May 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 3 units were distributed.
REASON Blood products may have been shipped at an
unacceptable temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-099-8.
CODE Unit numbers: 04E 71963, 04FK 54567,
04C 65855, 04S 78022, 04LE 89164, 04S 78009,
04R 16186, 04N 39452, 04FR 89233, 04C 66105,
34KW 08051, 04FJ 53896, 04FK 54412,
04FK 54415, 04LE 89221, 04R 16137, 04FR 89221.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letters dated March 14, 1996,
and July 2, 1997. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts.
QUANTITY 17 units were distributed.
REASON Blood products may have been shipped at an
unacceptable temperature.
_______________
PRODUCT Platelets, for further manufacture.
Recall #B-104-8.
CODE Unit 53G03980.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated May 1, 1997,
followed by letters to non-respondents on June
6 or 9, 1997. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT Data-Cyte Plus Reagent Red Blood Cells.
Recall #B-106-8.
CODE Lot DC-800, 634 kits, Lot DC-802, 585 kits
Lot DC-803, 679 kits, Lot DC-810, 497 kits.
MANUFACTURER Dade AG, Switzerland.
-10-
RECALLED BY Dade International, Inc., Miami, Florida, by
letters dated June 7, 1996, followed by
corrected antigen matrix sheets on June 11,
1996, July 8, 1996, and October 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates none remains on the market.
REASON Reagent Red Blood Cells, which: 1) were
positive for the Kell antigen, but labeled as
Kell negative; 2) were negative for the V
antigen, but labeled as V positive; or 3) weak
or negative reactions were obtained with an
Lea positive cell using anti-Lea antisera.
_______________
PRODUCT Platelets, Pheresis. Recall #B-110-8.
CODE Unit #17FX09741.
MANUFACTURER American Red Cross Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by telephone on May 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was distributed in
interstate commerce.
RECALLS AND FIELD CORRECTIONS: DEVICES == CLASS II
=========
_______________
PRODUCT Vacuum Relief Valves:
a) Model No. 4003103, (Sterile)
b) Model No. 4003203, (Non-Sterile).
Recall #Z-162/163-8.
CODE Lot Numbers: a) 7783.P09; b) 7778, 7837,
7815.
MANUFACTURER Quest Medical, Inc., Allen, Texas.
RECALLED BY Manufacturer, by letter October 1, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 38,609 units.
REASON The product may contain partially or
completely occluded one-way valve components.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Dade Moni-Trol Chemistry Control and Carbonate
Diluent, intended for use as unassayed quality
control material in quantitative clinical
chemistry quality control programs:
a) Catalog #B5106-10, Dade Moni-Trol Gold
Level 1X Chemistry Control and Carbonate
Diluent 1
-11-
b) Catalog #B5106-20, Dade Moni-Trol Gold
Level 2X Chemistry Control and Carbonate
Diluent 2
c) Catalog #B5106-75, Dade Moni-Trol ES Level
I.X Chemistry Control and Carbonate Diluent I,
d) B5106-85 Dade Moni-Trol ES Level II.X
Chemistry Control and Carbonate Diluent II.
Recall #Z-156/159-8.
CODE Lot numbers: a) XLG-101 and XLG-102; b)
XPG-201 and XPG-202; c) XLS-551 and XLS-552;
d) XPS-651 and XPS-652.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter dated November 25,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 8,291 units.
REASON Stability failure. The devices may not meet
the 5 day reconstituted stability
specification of less than 15 percent difference
for the Total T3 and Total T4 constituents.
_______________
PRODUCT Dade Actin Activated Cephaloplastin Reagent,
for use in the determination of the activated
partial thromboplastin time and other
coagulation procedures requiring an activated
partial thromboplastin reagent:
a) Catalog #B4218-1, 10 x 2 mL.,
b) Catalog #B4218-2, 10 x 10 mL.
Recall #Z-164/165-8.
CODE Lot numbers: a) APAC-636A; b) APAC-636B.
MANUFACTURER Dade Diagnostics of Puerto Rico, Inc., Aguada,
Puerto Rico.
RECALLED BY Manufacturer, by letter dated May 19, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Several thousand units were distributed.
REASON This reagent produces prolonged activated
partial thromboplastin times with normal and
abnormal controls and patient samples.
-12-
END OF ENFORCEMENT REPORT FOR NOVEMBER 12, 1997. BLANK PAGES MAY FOLLOW.
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