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.
March 25, 1998 98-12
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Keebler Sugar Creme Wafers, creme filled wafer
cookies, in 12 ounce packages, 12 packages per
case. Recall #F-285-8.
CODE Lot numbers: 026V, 027V, 027N.
MANUFACTURER Keebler/Sunshine Biscuits Inc., Sayreville, New
Jersey.
RECALLED BY Keebler Company, Elmhurst, Illinois, by letter and
press release on February 12, 1998, and by a Trade
Notice dated February 13, 1998. Firm-initiated
recall complete.
DISTRIBUTION Iowa, Nebraska, Kansas, South Dakota, Minnesota,
South Dakota, Missouri, Texas, Arkansas,
Louisiana, Oklahoma, Michigan, New Mexico,
Georgia, Florida and Alabama.
QUANTITY 513 cases were distributed.
REASON The product contains undeclared peanut wafer meal.
_______________
PRODUCT Brownie Mix. Individual pouches are labeled as
Martha White Moist-n-Fudgy Brownie Mix. In
addition cases labeled as Martha White Walnut
Brownie Mix are also being recalled because some
may contain the suspect pouches.
Recall #F-286-8.
CODE All production codes beginning with L7S03C.
MANUFACTURER Glister Mary Lee Corporation, Steelville,
Illinois.
RECALLED BY The Pillsbury Company, Minneapolis, Minnesota, by
electronic mail and by press release on February
4, 1998. Firm-initiated recall complete.
DISTRIBUTION Alabama, Arkansas, Georgia, Kentucky, Louisiana,
Mississippi, North Carolina, South Carolina,
Tennessee, Texas.
QUANTITY 1,195 cases (12 pouches per case) were
distributed.
REASON Product contains undeclared walnuts.
_______________
PRODUCT Select Brownie, net weight 3 ounces, individually
wrapped in clear cellophane, in cases of 12, 24
and 96. Recall #F-287-8.
CODE All product with an expiration date not greater
than March 8, 1998.
MANUFACTURER Select Bakery, Inc., Rockwell, North Carolina.
RECALLED BY Manufacturer, by letter dated January 23, 1998.
Completed recall resulted from sample analysis and
follow-up by the Georgia Department of
Agriculture.
DISTRIBUTION Georgia, North Carolina, South Carolina,
Tennessee.
QUANTITY 53,040 individually wrapped brownies were
distributed.
REASON Product contains undeclared walnuts.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Brunswick Anchovies Flat Fillets in olive oil, net
weight 56 g, 2 ounces. Recall #F-283-8.
CODE Cans are marked with a code identifying the date
of production. The same code appears on the bottom
of each tray. Cans are overwrapped thus obscuring
the code. UPC code is available (UPC 66613-25904).
Can codes are as follows: 200197, 250297, 030397,
160497, 170497, 180497, 190497, 210497, 220497,
230497, 240497, 250497, 260497, 280497, 290497,
300497, 100497, 140497, 150497 & 160497.
MANUFACTURER HEMA, Frionorte, S.A. Arica, Chile.
RECALLED BY Connors Brunswick, Inc., Portland, Maine, by
telephone on December 19, 1997, followed by fax.
Firm-initiated recall complete.
DISTRIBUTION Florida, Colorado, California, Tennessee,
Illinois, Texas, North Carolina, Arkansas.
QUANTITY Approximately 15,000 trays (18 cans per tray) were
distributed; firm estimated that 8-10,000 trays
remained on market at time of recall initiation.
REASON The product has excessive levels of histamine.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Mr. Pibb and Diet Coke carbonated beverages:
a) Mr. Pibb carbonated beverage in 6 and 12 packs;
b) Diet Coke carbonated beverages cans in 6, 12,
20 and 24 packs.
Recall #F-280/281-8.
CODE a) FEB0998FWA & AUG1098FWA packaged 24 cans per
case; b) FEB0998FWA, all codes are followed by the
military time of production.
MANUFACTURER Coca-Cola Enterprises, Fort Worth, Texas.
RECALLED BY Manufacturer, by letter sent by e-mail on December
2, 1997. Firm-initiated recall complete.
DISTRIBUTION Arkansas, Louisiana, Texas.
QUANTITY a) 25,439 cases 6-packs and 4,328 cases of 12
packs; b) 7,265 cases of 6-packs, 15,680 cases of
12-packs, and 8,138 cases of 20 packs and 12,944
cases of 24-packs were distributed; firm estimated
none remained on market at time of recall
initiation.
REASON Products are adulterated due to the presence of
chlorine.
_______________
PRODUCT Malt Beverage (Malta India), in 7 fluid ounce
glass bottles. Recall #F-282-8.
CODE Lot #2867.
MANUFACTURER Cerveceria India, Inc., Mayaguez, Puerto Rico.
RECALLED BY Manufacturer, by telephone on November 20, 1997
and December 1, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY 4,500 cases (24 bottles per case) were
distributed.
REASON Product has an off taste.
_______________
PRODUCT Cool Blue Raspberry Gatorade Thirst Quencher, in
32 fluid ounce bottles. Recall #F-288-8.
CODE Bottle cap code: CT12631A831/"TT:TT", where
"TT:TT" is equal to the military time 22:20
through 01:55 Case code: 12-32OZ PLASTIC CB RASP
33820 52000 JAN-31-98 M 3 "TT:TT" "XXXXX", where
"TT:TT" is the military time as described above
and "XXXXX" is the consecutive case code 00001
through 07023.
MANUFACTURER Quaker Oats Company, Mountaintop, Pennsylvania.
RECALLED BY Quaker Oats Company, Chicago, Illinois, by
memorandum dated February 20, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Hampshire, Connecticut, Vermont,
Massachusetts, New York, Virginia, Maryland,
Maine, and New Jersey.
QUANTITY 2,270 cases (12 bottles per case) were
distributed. Firm estimated that 40 percent of
product remained on market at time of recall
initiation.
REASON The product is unfit for food due to spoilage
caused by Byssochlamys fulva (mold).
_______________
PRODUCT Various Hostess snack cakes, all package sizes and
configurations of the following products:
a) Hostess HoHo's Chocolate Cake Rolled with
Creamy Filling
b) Hostess Twinkies Golden Sponge Cake with Creamy
Filling
c) Hostess Lights Low Fat Twinkies Golden Sponge
Cake with Creamy Filling
d) Hostess Cupcakes Chocolate Cake with Creamy
Filling
e) Hostess Lights Low Fat Cupcakes Chocolate Cake
with Cream Filling
f) Hostess Lights Low Fat Brownies Chocolate Iced
Fudge Brownies
g) Hostess Chocolicious Moist Chocolate Cake with
Chocolate Icing and Creamy Filling
h) Hostess Original Oat Bran Muffins
I) Hostess Valentines Frosted Yellow Cake with
Creamy Filling
j) Hostess Hoppers with Super Sprinkles Frosted
Yellow Cakes with Creamy Filling
k) Hostess Shortcake, 4 Dessert Cups
l) Hostess Fruit Pie Real Fruit Filling - Apple
m) Hostess Fruit Pie Real Fruit Filling - Cherry
n) Hostess Fruit Pie Real Fruit Filling -
Blueberry
o) Hostess Fruit Pie Real Fruit Filling - Peach
p) Hostess Fruit Pie Real Fruit Filling - Lemon
q) Hostess Frosted Honey Bun
r) Dolly Madison Bakery Cupcakes Creme-Filled
Devils Food. F-292/309-8.
CODE Affected products have an Expiration/Sell By/Last
Sale Date of JAN 22 through FEB 06 except the
HoHo's which have dates of JAN 29 through FEB 13,
all products have "57" as the plant indicator
code, which is the first two digits of the code
beneath the date on the cello packages, and as the
fourth and fifth digits of the code on boxes.
MANUFACTURER Interstate Brands Corporation, Schiller Park,
Illinois.
RECALLED BY Interstate Brands Corporation, Kansas City,
Missouri, by memorandum dated January 27, 1998,
and by press release. Firm-initiated recall
complete.
DISTRIBUTION Arkansas, Illinois, Indiana, Iowa, Kansas,
Kentucky, Louisiana, Maryland, Michigan,
Minnesota, Mississippi, Missouri, Nebraska, Ohio,
Oklahoma, Pennsylvania, South Dakota, Tennessee,
Texas, West Virginia and Wisconsin.
QUANTITY 1,052,466 packages were distributed; firm
estimates none remain on market.
REASON At the time the products were being manufactured,
asbestos was improperly removed from the plant,
allowing asbestos fibers into the plant
environment.
_______________
PRODUCT Michaels 100% Natural Popcorn:
a) Natural Butter flavored popcorn, 3/7 oz. Bag;
b) Natural White Cheddar Popcorn, 1 1/4 oz. Bag;
c) Natural Cheddar Cheese Popcorn, ยด oz. Bag.
Recall #F-310/312-8.
CODE All codes less than or equal to 7056.
MANUFACTURER Michael's Popcorn Company, also known as MPC
Marketing, Forney, Texas.
RECALLED BY Manufacturer, by letter dated April 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY a) 327,700 units; b) 1,426,368 units; c) 2,798,520
units were distributed.
REASON Product is misbranded - Labeling claim,
"Enrichment with Vitamin C", is false and
misleading, since the product contains no Vitamin
C.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
============
_______________
PRODUCT Propranolol HCL Extended-release Capsules,
indicated in the management of hypertension, Rx.
Brand name BetachronTM, under the following
labels: TEVA, URL, Shein, Parmed, Qualitest,
Rugby, Geneva, Moore, Major, Zenith Goldline:
a) Propranolol HCL 60 mg Extended Release (ER)
Capsules, 100 count bottles, NDC # 0258-3609-01;
b) Propranolol HCL 80 mg ER Capsules, 100 count
bottles, NDC # 0258-3610-01.
c) Propranolol HCL 120 mg ER Capsules, 100 count
bottles, NDC # 0258-3611-01.
d) Propranolol HCL 160 mg ER capsules, 100 count
bottles, NDC # 0258-3612-01.
Recall #D-100/103-8.
CODE 60 mg strength: (20 lots)
6C083 (3/98), 6C085 (3/98), 6C087 (3/98), 6D001
(3/98), 6D003 (3/98), 6D005 (3/98), 6D007 (4/98),
6E004 (5/98), 6E005 (5/98), 6F022 (5/98), 6F023
(5/98), 6G001 (5/98), 6G003 (5/98), 6G004 (5/98),
6G005 (5/98), 6G006 (6/98), 6G019 (6/98), 6G020
(6/98), 6G021 (6/98) & 6G022 (6/98).
80 mg strength: (6 lots)
6D068 (3/98), 6E007 (4/98), 6E007A (4/98), 6F005
(7/98), 6F006 (7/98) & 6H011 (7/98).
120 mg strength: (9 lots)
6C089 (3/98), 6C090 (3/98), 6D069 (3/98), 6E008
(4/98), 6E008A (4/98), 6F007 (6/98), 6H015 (6/98),
6H016 (6/98) and 6F008 (6/98).
160 mg strength: (7 lots)
6C091 (3/98), 6C092 (4/98), 6E009 (4/98), 6E009A
(4/98), 6F009 (5/98), 6F010 (7/98), and 6H017
(7/98).
MANUFACTURER Inwood Laboratories, Inc., (a subsidiary of Forest
Laboratories, Inc.), Inwood, New York.
RECALLED BY Manufacturer, by letter on March 4, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 294,016 bottles were distributed as follows:
Total 60 mg bottles distributed : 88,052
Total 80 mg bottles distributed : 90,220
Total 120 mg bottles distributed: 77,755
Total 160 mg bottles distributed: 37,989.
REASON Dissolution failure.
_______________
PRODUCT MGP Hyoscyamine Oral Drops, hyoscyamine sulfate
0.125 mg/mL; Rx oral liquid used as adjunctive
therapy in the treatment of peptic ulcers,
treatment of infant colic, et al. packaged in
15 mL bottle with 0.25 mL dropper. NDC
#60432-103-15. Recall #D-104-8.
CODE Lot numbers: 21387A, 21400A, 21466A, 21466C.
MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove,
Illinois.
RECALLED BY Manufacturer, by letter dated February 24, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Indiana, Pennsylvania, California, North
Carolina, Illinois, Florida, Ohio, Tennessee,
Missouri, South Dakota, Utah, Kentucky, New York,
Vermont, North Dakota, Michigan.
QUANTITY 21,500 units were distributed; firm estimated that
25 percent of product remained on market at time
of recall initiation.
REASON Mislabeling - Labeling indicates each dropperful
contains 0.125 mg drug based on a 1 mL dropper,
however these lots are packaged with 0.25 mL
dropper.
_______________
PRODUCT Procainamide Hydrochloride Extended Release
Tablets, USP, 500 mg, in 100 tablet bottles,
indicated for treatment of documented arrhythmias,
under the Schein Pharmaceutical label.
NDC #0364-0716-01. Recall #D-107-8.
CODE Lot #D6A0205 EXP 2/98.
MANUFACTURER Danbury Pharmacal, Inc., a subsidiary of Schein
Pharmaceutical, Danbury, Connecticut.
RECALLED BY Manufacturer, by letter faxed on March 2, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Georgia, Idaho,
Illinois, Ohio, Massachusetts, Minnesota, New
Mexico, New Jersey, Pennsylvania, Tennessee,
Kentucky, Virginia, Indiana, West Virginia.
QUANTITY 1,955 bottles were distributed.
REASON Dissolution failure at 4th hour interval (24 month
stability test).
_______________
PRODUCT Tisit Blue Gel Lice Treatment (Pyrethrins
0.3%/Piperonyl Butoxide 3.0%), in 1 ounce tubes,
OTC pediculicide. Recall #D-108-8.
CODE Lot numbers: 50301, 60301, 70302.
MANUFACTURER Pfeiffer Pharmaceuticals, Inc., also known as SSS
Company, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter dated on or about January
12, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,668 tubes were distributed.
REASON Subpotent for Pyrethrins (one of the two active
ingredients).
_______________
PRODUCT Compressed Oxygen, USP, Rx, in D, E, and M6 high
pressure cylinders. Recall #D-111-8.
CODE Lot numbers: lots 80341, 80342, 80343, 80344,
80351, 80361, 80362, and 80401.
MANUFACTURER Alick's Home Medical Equipment, Inc., Elkart,
Indiana.
RECALLED BY Manufacturer, by telephone between February 12 and
26, 1998. Firm-initiated recall complete.
DISTRIBUTION Indiana and Michigan.
QUANTITY 128 cylinders were distributed.
REASON Current good manufacturing practice (CGMP)
deviations - Failure to maintain working vacuum
gauge for proper cylinder purging.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Prevpac Triple Therapy (lansopazole capsules 30
mg/Amoxicillin capsules 500 mg/Clarithromycin
tablets 500 mg), Rx, used for the treatment of
duodenal ulcers associated with H. Pylori. NDA
50-757; NDC 0300-3702-01 on commercial box of 14
daily patient packs (blister cards), NDC
0300-3702-10 on professional sample daily patient
pack, NDC 0300-3702-11 on commercial single daily
patient pack; NDC 0300-3702-00 on professional
sample box of 14 daily patient packs; 14 daily
patient packs per package, 8 packages per case.
Recall #D-105-8.
CODE Lot #35 001 2Z EXP 08/99.
MANUFACTURER Anderson Packaging, Rockford, Illinois (contract
packager).
RECALLED BY Tapp Pharmaceuticals, Inc., Deerfield, Illinois,
by letters dated January 30, 1998, and February 2,
1998. Firm-initiated recall ongoing.
DISTRIBUTION West Virginia, California, Oregon, Illinois,
Tennessee, New York, North Carolina, New Mexico,
Missouri, Colorado, Indiana, Texas, Minnesota,
Louisiana, Maryland, Massachusetts, Alabama,
Idaho, Connecticut, Georgia, Mississippi.
QUANTITY 1,434 cases were distributed
REASON Mislabeling - Some product labeled as
"professional samples, not for sale" were released
for sale.
_______________
PRODUCT Triamcinolone Acetonide Lotion USP, 0.1%, in 60 ml
bottles, Rx a topical corticosteroid used as
anti-inflammatory and antipruritic agents, under
the Thames, Zenith Goldline, and Qualitest labels.
NDC numbers: 49158-211-32, 0182-1777-68,
0603-7855-49. Recall #D-106-8.
CODE Lot #M283 EXP 2/2002.
MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma, New
York.
RECALLED BY Manufacturer, by telephone on March 2-3, 1998,
followed by letter on March 4, 1998. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, California, Louisiana
Kentucky, Florida, Oregon, Virginia, Alabama.
QUANTITY 2,559 bottles were distributed.
REASON Unapproved raw material source used in product's
manufacturing.
_______________
PRODUCT Elta Swiss Skin Cream in 16 ounce and 28 ounce
plastic containers. Recall #D-109-8.
CODE Lot numbers: 7606 (16 oz), 7607 (28 oz).
MANUFACTURER Swiss American Products, Inc., Dallas, Texas.
RECALLED BY Manufacturer, by letters dated January 12, 1998,
and February 15, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 58 16-ounce containers and 168 28-ounce containers
were distributed; firm estimated that 20 16-ounce
and 25 28-ounce containers remained on market at
time of recall initiation.
REASON Short weight fill (lot 7607 only) and unapproved
drug claims. (Note: Both lots bore unapproved
drug claims, labeling issued for correction,
product itself not recalled (lot 7606)).
_______________
PRODUCT API Diphenhist Capsules (Diphenhydramine HCL), 25
mg, in 100 unit bottles, allergy medicine
antihistamine. Recall #D-110-8.
CODE Lot #3600208 EXP 11/99.
MANUFACTURER York Pharmaceuticals, Inc., Kansas City, Kansas.
RECALLED BY Manufacturer, by telephone on March 5, 1998, and
by letter faxed on March 6, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Tennessee, Texas, New York.
QUANTITY 2,040 bottles were distributed.
REASON Mislabeling - Caplet product labeled as
containing capsules.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT Source Plasma. Recall #B-557-8.
CODE Unit #FT02086644.
MANUFACTURER Serologicals, Inc., Clarkston, Georgia.
RECALLED BY Manufacturer, by letter dated August 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody to
the immunodeficiency virus type 1 (anti-HIV-1),
was distributed after the donor subsequently
tested repeatedly reactive for anti-HIV-1, Western
blot indeterminate.
_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Fresh Frozen Plasma
d) Cryoprecipitated AHF
e) Red Blood Cells, for further manufacture
f) Fresh Frozen Plasma, for further manufacture;
g) Recovered Plasma.
Recall #B-702/708-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER Inland Northwest Blood Center, Spokane,
Washington.
RECALLED BY Manufacturer, by letter dated July 26, 1997,
September 15, 24, and 25, 1997, and December 16,
17, and 18, 1997. Firm-initiated recall complete.
DISTRIBUTION Florida, Washington state, California, Alaska,
Idaho.
QUANTITY a) 37 units; b) 3 units; c) 10 units; d) 2 units;
e) 1 unit; f) 8 units; g) 4 units were
distributed.
REASON Blood products tested negative for the antibody to
the hepatitis B core antigen (anti-HBc), but were
collected from donors who previously tested
repeatedly reactive for anti-HBc on two separate
occasions.
_______________
PRODUCT Platelets, Pheresis. Recall #B-711-8.
CODE Unit #49P37122.
MANUFACTURER American Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone on December 22, 1997,
and by letter dated December 26, 1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product had a platelet yield above the
acceptable limit.
_______________
PRODUCT Source Plasma. Recall #B-712-8.
CODE Unit numbers: L0023979, L0024253, L0024424,
L0024653, L0024424.
MANUFACTURER Sera Tec Biologicals Limited Partnership, Loraine,
Ohio.
RECALLED BY Manufacturer, by fax on December 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 5 units were distributed.
REASON Blood products were collected from a donor who had
been incarcerated.
_______________
PRODUCT Source Plasma. Recall #B-713-8.
CODE Unit numbers: L0024886 and L0024986.
MANUFACTURER Sera Tec Biologicals Limited Partnership,
Loraine, Ohio.
RECALLED BY Manufacturer, by fax on December 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who had
been incarcerated.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-714/715-8.
CODE Unit numbers: 22387-1487 and 22390-8415.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Manufacturer, by letter dated March 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nevada.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as endemic
for malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-716-8.
CODE Unit #0161163.
MANUFACTURER The Blood Center of New Jersey, East Orange,
New Jersey.
RECALLED BY Manufacturer, by telephone on June 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was not refrigerated within eight
hours of Whole Blood collection.
_______________
PRODUCT Red Blood Cells. Recall #B-717-8.
CODE Unit #53FL57585.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated February 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered as endemic for
malaria.
_______________
PRODUCT a) Red Blood Cells b) Platelets.
Recall #B-718/719-8.
CODE Unit numbers: a) 53GJ86749 and 53FL54658
b) 53FL54658.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated February 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY a) 2 units; b) 1 unit was distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-720/721-8.
CODE Unit numbers: 22382-9065, 22383-8850.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Manufacturer, by letters dated June 3, 1996, and
March 19, 1997. Firm-initiated recall complete.
DISTRIBUTION Mississippi and Nevada.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor who had
been deferred because of travel to an area
designated as endemic for malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-722-8.
CODE Unit #28109-0681.
MANUFACTURER United Blood Services, San Angelo, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on January 22, 1998, and by letter on
February 20, 1998. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported travel to an area designated as endemic
for malaria.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-726-8.
CODE Unit #Q66274.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc.,
Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by telephone on December 6, 1996,
and by letter dated January 27, 1997. Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
PLA1 antibody.
_______________
PRODUCT a) Red Blood Cells; b) Platelets, Pooled.
Recall #B-727/728-8.
CODE Unit numbers: a) 932078; b) P62623.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on February 11, 1998,
and by letter dated February 17, 1998. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products corresponded to Fresh Frozen Plasma
which were returned because of confirmed fibrin
clots.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-731-8.
CODE Unit #03GH23766.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on February 2, 1998.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood
Cells that were positive for propionibacterium
acne.
_______________
PRODUCT Platelets, Pheresis. Recall #B-734-8.
CODE Unit numbers: 22389-6680-01, 22389-6680-02,
22390-1223-01, 22390-1223-02.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Manufacturer, by letter dated January 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nevada.
QUANTITY 4 units were distributed.
REASON Blood products 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, Western blot negative.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-709-8.
CODE Unit 28108-9659.
MANUFACTURER United Blood Services, San Angelo, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on December 12, 1997, and by letter
dated January 20, 1998. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole
Blood identified as a difficult draw.
______________
PRODUCT a) Red Blood Cells; b) Platelets, Pooled.
Recall #B-724/725-8.
CODE Unit numbers: a) 6298591, 6298592
b) P62560, 62557.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on February 3, 1998,
and by letter dated February 5, 1998.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from donors who
exceeded the donation acceptance criteria for body
temperature.
_______________
PRODUCT Platelets. Recall #B-733-8.
CODE Unit #22388-2941.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Manufacturer, by letter dated November 6, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole
Blood designated as a difficult collection.
_______________
PRODUCT Platelets. Recall #B-735-8.
CODE Unit #22393-0508.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Manufacturer, by telephone on May 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole
Blood for which no phlebotomy end time was
recorded.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
==========
_______________
PRODUCT IVAC Medsystem III Administration Sets:
a) Model 28034 IVAC Vented/Unvented 2 "Y" Site; b)
Model 28053 IVAC Vented/Unvented Low Sorbing
Tubing Set No "Y" Site Set.
Recall #Z-039/040-8.
CODE Lot numbers: a) 707459, 708427; b) 707414,
707435, 708410.
MANUFACTURER Alaris Medical Systems, Inc., Creedmoor, North
Carolina.
RECALLED BY Alaris Medical Systems, Inc., San Diego,
California, by letter on October 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Puerto Rico.
QUANTITY 14,500 unit cases (50 per case) of Lot #707456,
14,800 cases (50 per case) of Lot 708426, 1,200
cases (20 per case) of Lot 707414; 3,000 cases (20
per case) of lot 707435, and 10,500 cases (20 per
case) of Lot 708410 were distributed; firm
believes there are none of the affected devices
left in distribution.
REASON Devices were mis-assembled. The tubing sections
were reversed which could result in medication not
being delivered and/or blood being drawn from the
patients I.V. site.
_______________
PRODUCT Hewlett Packard Model M1026A Anesthetic Gas
Analyzer (AGM) which include an 02 sensor, used to
measure the anesthetic and respiratory gases of a
pataient under anesthesia.
Recall #Z-415-8.
CODE Serial numbers with Prefix 3716A*** and 3727A***.
MANUFACTURER Hewlett Packard GmbH, Boeblingen, Germany.
RECALLED BY Hewlett Packard, Andover, Massachusetts, by June
5, 1998. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,284 units were distributed.
REASON The units may display an inaccurate oxygen reading
due to software problem.
_______________
UPDATE Recall Z-358/359-8, MCA and NOVA Hemodialyzers,
which appeared in the March 11, 1998 Enforcement
Report listed an incorrect lot number for Z-358-8.
It listed "855970821" but it should read
"855970821A" for the MCA 200 Catalog No. 201-855.
Also the firm added an additional lot number
"855970814A" for recall Number Z-358-8. MCA200
Catalog Number 201-855.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ===========
_______________
PRODUCT Tylan 40 Sulfa Type A Medicated Article,
in 50 pound bags, (tylosin/sulfamethazine).
Recall #V-019-8.
CODE Lot #633A57 EXP 3/99.
MANUFACTURER Consolidated Nutrition, L.C., Hagerstown, Indiana
(shipper).
RECALLED BY Consolidated Nutrition, L.C., Fort Wayne, Indiana,
by telephone on November 18, 1997. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY 3 bags were distributed.
REASON The three customers did not hold a feed mill license
which enabled them to purchase Category II Type A
medicated articles. A Category II Type A medicated
article - Tylan 40 Sulfa-G - was shipped instead of
Tylan 40 which is a Category I Type A medicated
article.
END OF ENFORCEMENT REPORT FOR MARCH 25, 1998. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
![[FDA HOME PAGE]](https://webarchive.library.unt.edu/eot2008/20090119125459im_/http://www.fda.gov/icon/iconhome.gif)