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 27, 1996
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Drinking water under the following labels:
(a) Crisp 'n Clear Premium Drinking Water, in
20 ounce, 1 liter and 2 liter plastic bottles;
(b) Natural Springs Drinking Water, in 1
gallon, 2-1/2 gallon, and 5 gallon plastic
containers. Recall #F-043-7.
CODE (a) All lots in 20 ounce, 1 liter and 2 liter
plastic bottles produced in July, August and
September 1996; (b) All 1 gallon 2-1/2 gallon
and 5 gallon containers bottled in July,
August and September 1996.
MANUFACTURER Marion Pepsi-Cola Bottling Company, Marion,
Illinois.
RECALLED BY Manufacturer, by press release on September
27, 1996, followed by internal bulletins dated
September 27, 1996, and October 2, 1996, and
telephone on October 7-12, 1996. Firm-
initiated recall complete.
DISTRIBUTION Missouri, Illinois, Arkansas, Kentucky,
Tennessee.
QUANTITY (a) 403,608 20-ounce bottles and 42,945 1-
liter bottles; (b) 67,789 gallon, 3,505 2-1/2-
gallon and 980 5-gallon containers were
distributed.
REASON Product is adulterated due to the presence of
coliforms.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Solopak Sodium Chloride Injection USP, 0.9%,
preservative free, packaged in 2 ml, 3 ml, and
10 ml pre-filled syringes, used for diluting
or dissolving compatible parenteral
medications. Recall #D-039-7.
CODE Lot numbers: 96E002B, 96E004B, 96D015B.
MANUFACTURER SoloPak Medical Products, Franklin Park,
Illinois.
RECALLED BY SoloPak Medical Products, Elk Grove Village,
Illinois, by letter dated October 25, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Wisconsin, Tennessee, Texas,
Illinois, North Carolina, New Jersey, Florida,
Oklahoma, Louisiana, New York, California,
Pennsylvania, Michigan.
QUANTITY 47,520 syringes were distributed; firm
estimated that 48 percent of the syringes
remained on market at time of recall
initiation.
REASON Lack of adequate assurance of sterility.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT E-Z-EM brand barium sulfate suspensions, Rx,
contained in 64 fluid ounce HDPE jugs:
(a) Liquid Polibar Plus; (b) Liquid E-Z-Paque;
(c) E-Z-AC. Recall #D-040/042-7.
CODE (a) Catalog #L168, Lot numbers: 1B8693A,
1B8693B, 1B8693C, 1B8694A, 1B8694B, 1B8694C,
1B8695A, 1B8695B and 1B8695C. All lots expire
1/97; (b) Catalog #L186, Lot numbers: 4B8690,
4B8691, 4B8692 (expire 4/97), 5B9050, 5B9051
and 5B9052 (expire 5/97); (c) Catalog #L178,
Lot numbers: 1B8669A, 1B8669B, 1B8669C (expire
1/97), 2B8670A, 2B8670B, 2B8670C (expire
2/97), 2B8671A, 2B8671B, and 2B8671C (expire
2/97).
MANUFACTURER Therapex, Division of E-Z-EM Canada Inc.,
Providence of Quebec, Canada.
-2-RECALLED BY E-Z-EM, Inc., Westbury, New York
(distributor), by telephone on October 9,
1996, followed by letter october 22, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Volume of product in commerce:
(a) Liquid Polibar Plus, Catalog #L168
1B8693A: 140 units
1B8693B: 149 units
1B8693C: 98 units
1B8694A: 146 units
1B8694B: 142 units
1B8694C: 111 units
1B8695A: 144 units
1B8695B: 157 units
1B8695C: 109 units
(b) Liquid E-Z-Paque, Catalog #L186
4B8690: 435 units
4B8691: 434 units
4B8692: 426 units
5B9050: 428 units
5B9051: 426 units
5B9052: 426 units.
(c) E-Z-AC, Catalog #L178
1B8669A: 146 units
1B8669B: 146 units
1B8669C: 111 units
2B8670A: 151 units
2B8670B: 140 units
2B8670C: 10 units
2B8671A: 148 units
2B8671B: 29 units
2B8671C: 60 units.
REASON Lots fail specifications for total solids and
assay; lots are also clumping and are
difficult to resuspend.
_______________
PRODUCT Phentermine HCl Capsules, USP, 30 mg
(Blue/Clear), in HDPE bottles of 1,000, Rx
product indicated in the management of
exogenous obesity. Recall #D-043-7.
CODE Lot No. 6H163 EXP 8/00
Lot No. 6H164 EXP 8/00
Lot No. 6H165 EXP 8/00.
MANUFACTURER Eon Labs Manufacturing, Inc., Laurelton, New
York.
RECALLED BY Manufacturer, by letter on October 28, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
-3-QUANTITY The following quantities were distributed per
lot:
6H163 - 2,395 bottles
6H164 - 2,458 bottles
6H165 - 2,447 bottles.
REASON Some lots are labeled with incorrect
expiration -- A four-year expiration period
was assigned rather than a two-year period.
_______________
PRODUCT Betuline Lotion, in 2 ounce bottles, topical
methyl salicylate, OTC drug indicated for
temporary relief from minor aches and pains.
Recall #D-044-7.
CODE Lot #55-060 EXP 04/97.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale,
Michigan.
RECALLED BY Manufacturer, by letter on September 27, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Indiana, Kansas, Michigan, Missouri,
New York, North Carolina, Ohio, Pennsylvania.
QUANTITY 17,640 bottles were distributed.
REASON Potency is not assured through expiration date
-- One stability lot is subpotent for methyl
Salicylate.
_______________
PRODUCT Dermaline Skin-Bleaching Cream, packed in 1
ounce, 2 ounce and 4 ounce plastic jars, a
non-prescription skin cream. Recall #D-045-7.
CODE IND #13505.
MANUFACTURER Leivon Cosmetics, Inc., Santo Domingo,
Dominican Republic.
RECALLED BY Castillo Distributor, Inc., Little Ferry, New
Jersey, by letter on October 29, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION New York, New Jersey.
QUANTITY Approximately 8 cases (144 8-ounce jars per
case); 7 cases (144 2-ounce jars per case);
719 cases (48 4-ounce jars per case) were
distributed; firm estimated that little or no
product remained on market at time of recall
initiation.
REASON FDA analysis found that product does not
contain labeled active ingredient,
hydroquinone.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c)
Platelets; (d) Fresh Frozen Plasma; (e)
Recovered Plasma. Recall #B-485/489-6.
-4-CODE Unit numbers: (a) 6005664; (b) 1335802,
1837281, 7710774, 1446158, 8125231;
(c) 1335802, 1837281, 7710774, 1446158,
8125231; (d) 1335802, 7710774, 8125231; (e)
1837281, 1446158.
MANUFACTURER LifeSource Blood Services, Glenview, Illinois.
RECALLED BY Manufacturer, by letters dated December 18,
19, 20, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY (a) 1 unit; (b) 5 units; (c) 5 units; (d) 3
units; (e) 2 units.
REASON Blood product, which tested initially reactive
for HIV-1, EIA repeat negative and Western
Blot indeterminate; donor was subsequently not
deferred and products were distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c)
Platelets; (d) Fresh Frozen Plasma; (e)
Cryoprecipitate AHF; (f) Source Leukocytes;
(g) Platelets, further manufacturing; (h)
Recovered Plasma. Recall #B-523/530-6.
CODE Unit numbers: 31T26238, 31T28580, 31T34357,
31T39341, 31T45097, 31T46677, 31T50570,
31T55355, 31T57431, 31T59725, 31T63742,
31T68772, 31T71919, 31T74551, 31T76570,
31T82531, 31T88406, 31T92445, 31T94597,
31T97707, 31N40940, 31T05137, 31V20471,
31T15917, 31T18879, 31T20853.
MANUFACTURER American Red Cross, Buffalo, New York.
RECALLED BY American Red Cross, Rochester, New York;
(American Red Cross National Headquarters,
Rosslyn, Virginia (Recovered Plasma), by
letter on various dates in February 1996.
Firm-initiated recall complete.
DISTRIBUTION New York, Pennsylvania, California, Georgia,
Maryland, Missouri, South Carolina, Tennessee,
Switzerland.
QUANTITY (a) 1 unit; (b) 25 units; (c) 19 units; (d) 8
units; (e) 7 units; (f) 1 unit; (g) 2 units;
(h) 17 units were distributed.
REASON Blood products, which tested non-reactive to
anti-HIV-1, but collected from a donor who
initially tested IR for anti-HIV-1, no repeat
anti-HIV testing was performed; donor was
subsequently allowed to be reentered
improperly, and products were distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red
Blood Cells, Deglycerolized; (d) Platelets;
(e) Platelets, Pheresis; (f) Fresh Frozen
-5- Plasma; (g) Single Donor Plasma Liquid; (h)
Cryoprecipitated AHF; (i) Recovered Plasma.
Recall #B-534/542-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1191 for individual unit numbers recalled.
MANUFACTURER The American National Red Cross, Arlington,
Virginia.
RECALLED BY Manufacturer, by letters from 1988 through
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 11,286 units of various blood
products were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1) and the hepatitis B
surface antigen (HBsAg) but were collected
from donors who previously tested repeatedly
reactive for anti-HIV-1 or HBsAg and had
confirmatory testing inappropriately repeated
or indeterminate Western blots incorrectly
interpreted as negative.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall B-545/546-6.
CODE Unit #40GN10981.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated February 5,
1996. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit of each component.
REASON Blood products tested initially reactive for
HBsAg and then tested into compliance.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-640/642-6.
CODE Unit #38F01212.
MANUFACTURER American Red Cross, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by telephone on or about January
23, 1995. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit of each component were distributed.
REASON Blood products were collected from a donor who
tested repeat reactive for HBsAg.
_______________
PRODUCT Recovered Plasma. Recall #B-664-6.
CODE Unit numbers: 06GE14760, 06LR82215,
06FR20153, 06GE17351, 06LR80684, 06LV75749,
06LT56872, 06GE14791, 06LP42293, 06FK51763,
06GK12084, 06LS82447.
-6-MANUFACTURER American Red Cross, Los Angeles.
RECALLED BY Manufacturer, by letters dated August 12 and
30, 1993, and November 24, 1993. Firm-
initiated recall complete.
DISTRIBUTION New Jersey, New York, The Netherlands.
QUANTITY 12 units were distributed.
REASON Blood products tested repeat reactive for HIV.
_______________
PRODUCT Red Blood Cells. Recall #B-706-6.
CODE Unit numbers: X34424, L24375, L46697.
MANUFACTURER Blood Bank of San Bernardino and Riverside
Counties, San Bernardino, California.
RECALLED BY Manufacturer, by letter dated July 26, 1993.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 3 units were distributed.
REASON Blood products tested negative for all
infectious diseases were collected from a
donor who previously tested IR for anti-HIV-1,
and was never properly reentered.
_______________
PRODUCT (a) Albuminar-25; (b) Albuminar-20; (c)
Albuminar-5; (d) Monoclate-P; (e) Plasma Plex.
Recall #B-026/030-7.
CODE (a-c & e) All in-date lots; (d) Lot #P72304.
MANUFACTURER Centeon L.L.C., Kankakee, Illinois.
RECALLED BY Centeon L.L.C., A company of Armour and
Behring. King of Prussia, Pennsylvania, by
telephone on September 20, 1996, and by
letters on September 23 and 24, 1996, and
October 4, 1996. Firm-initiated recall
ongoing. See also FDA talk paper T96-67,
October 4, 1996.
DISTRIBUTION Nationwide and international.
QUANTITY 18,508 - 50 ml vials and 1,677 - 500 ml vials
of 5%, and 70,922 - 50 ml vials and 52,135 -
100 ml vials of 25% Albuminar in the dropped
lot category were distributed. The firm
estimates that 30% of the vials remain on the
market; 1,595 vials of Monoclate-P were
distributed, with the firm estimating that 250
vials remain on the market.
The amount of Albuminar and Plasma Plex
distributed is not available at this time.
The firm estimates that 30% of the distributed
product remains on the market.
REASON Biological products that are sensitive to
environmental contamination may not have been
processed according to current Good
Manufacturing Practices.
-7-_______________
PRODUCT Red Blood Cells. Recall #B-066-7.
CODE Unit #0657919.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo,
Texas.
RECALLED BY Manufacturer, by telephone on February 6,
1996, followed by letters dated February 8 and
9, 1996. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
immigrated from a malarial endemic area.
_______________
PRODUCT Platelets. Recall #B-078-7.
CODE Unit numbers: 36P20707 and 36P26113.
MANUFACTURER American Red Cross, Columbia, South Carolina.
RECALLED BY Manufacturer, by telephone and by letter dated
May 10, 1995. Firm-initiated recall complete.
DISTRIBUTION Georgia and South Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
exposed to hepatitis.
_______________
PRODUCT Platelets, pheresis. Recall #B-085-7.
CODE Unit #36Q43009.
MANUFACTURER American Red Cross Blood Services, Columbia,
South Carolina.
RECALLED BY Manufacturer, by telephone on November 24,
1995. Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
was taking the drug Proscar at the time of
donation.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-086/087-7.
CODE Unit numbers: (a) 1222126, 1222133, 1222138,
1706175, 3127667, 3127668, 4109854; (b)
1706175.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on May 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY (a) 7 units; (b) 1 unit.
REASON Blood products corresponded to a unit of
Pooled Platelets which was positive for
Staphylococcus aureus.
-8-_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-090/091-7.
CODE Unit #23031-8103.
MANUFACTURER United Blood Services, Billings, Montana.
RECALLED BY Manufacturer, by letter August 3, 1994. Firm-
initiated recall complete.
DISTRIBUTION Montana.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor
whose health history screening was
inadequately performed.
_______________
PRODUCT Platelets. Recall #B-092-7.
CODE Unit #L25247.
MANUFACTURER H.C.S.C. Blood Center, Bethlehem,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on August 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product was collected from a donor whose
health history screening was inadequately
performed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-093/094-7.
CODE Unit #23130-6011.
MANUFACTURER United Blood Services, Billings, Montana.
RECALLED BY Manufacturer, by letter dated May 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
reported a history of body piercing two months
prior to donation.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Recovered Plasma. Recall #B-095/099-7.
CODE Unit numbers: (a) 30G86549, 30Y37362,
30X40720, 30X54667, 30H88208, 30J82030,
30Y66071, 30Y66790, 30Y72047, 30FX32492; (b)
30X54667, 30FX32492; (c) 30X54667, 30J82030,
(d) 30Y66790; (e) 30G86549, 30Y37362,
30X40720, 30H88208, 30Y66071, 30Y66790,
30FX32492;
MANUFACTURER American Red Cross Blood Services; Ashley,
Pennsylvania.
-9-RECALLED BY Manufacturer, by letter dated December 6,
1995. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY (a) 10 units; (b) 2 units; (c) 2 units; (d) 1
unit; (e) 7 units were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1) were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Cryoprecipitated AHF; (d) Recovered Plasma.
Recall #B-100/103-7.
CODE Unit numbers: 30F61116, 30F62204.
MANUFACTURER American Red Cross Blood Services, Ashley,
Pennsylvania.
RECALLED BY Manufacturer, by letters dated December 27 and
29, 1995. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania and New York.
QUANTITY 2 units of each component were distributed.
REASON Blood products tested negative for 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 (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-104/105-7.
CODE Unit numbers: 21GM44257 and 21GM46348.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letters of February 16 and
21, 1996. Firm-initiated recall complete.
DISTRIBUTION California, Washington state.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor who
was taking the drug Proscar.
_______________
PRODUCT Platelets. Recall #B-107-7.
CODE Unit numbers: J07085 J07086 J07088 J07090
J07091 J07092 J07094 J07095 J07096 J07101
J07102 J07103.
MANUFACTURER H.C.S.C. Blood Center, t/a Miller Memorial
Blood Center, Bethlehem, Pennsylvania.
RECALLED BY Manufacturer, by letters dated April 3, 1996,
and June 24, 1996. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY 12 units were distributed.
-10-REASON Blood products were stored below specified
temperature range.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-547/548-6.
CODE Unit #40GN11000.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated February 5,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested initially reactive for
HBsAg and then tested into compliance.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall B-584/585-6.
CODE Unit #40GV34620.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated April 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly
reactive for the hepatitis B surface antigen
(HBsAg), and then were subjected to additional
retesting, were distributed.
_______________
PRODUCT (a) Platelets, Pheresis; (b) Source Plasma.
Recall #B-587/588-6.
CODE Unit numbers: (a) 40Z02027, 40Z02064; (b)
40P03137.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated February 27,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY (a) 2 units; (b) 1 unit was distributed.
REASON Blood products which tested repeatedly
reactive for HBsAg, were subjected to
additional retesting, or tested negative for
HBsAg, were collected from a donor who
previously tested repeatedly reactive for
HBsAg.
_______________
PRODUCT Recovered Plasma. Recall #B-589-6.
CODE Unit #40GR43986.
-11-MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by questionable plasma inquiry
dated April 10, 1996. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the hepatitis B surface antigen (HBsAg) and
was subjected to additional retesting.
_______________
PRODUCT Platelets, Pheresis. Recall #B-675-6.
CODE Unit numbers 07M24460 and 07M24461.
MANUFACTURER American Red Cross, Tucson, Arizona.
RECALLED BY Manufacturer, by letter dated April 23, 1993.
Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 2 units were distributed.
REASON Blood products were incorrectly tested for
HBsAg.
_______________
PRODUCT Platelets. Recall #B-075-7.
CODE Unit #53T33841.
MANUFACTURER American Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone on or about
February 9, 1996, followed by letter on
February 14, 1996. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product had an incorrect ratio of blood
to anticoagulant.
_______________
PRODUCT Red Blood Cells. Recall #B-076-7.
CODE Unit numbers 53FH53336, 53FH53350.
MANUFACTURER American Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone on March 4, 1996,
and by letter dated March 18, 1996. Firm-
initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 2 units were distributed.
REASON Blood products were collected from donors
whose hematocrit was not determined in donor
suitability.
_______________
PRODUCT Red Blood Cells. Recall #B-077-7.
CODE Unit numbers: 17178-8186, 17178-8187.
MANUFACTURER United Blood Services, McAllen, Texas.
-12-RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by
letter on April 16, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units were distributed.
REASON Red blood cells remained at room temperature
for an unknown amount of time.
_______________
PRODUCT Red Blood Cells. Recall #B-083-7.
CODE Unit #017FH34709 (split unit).
MANUFACTURER American Red Cross, St. Paul, Minnesota.
RECALLED BY Manufacturer, by telephone on November 8,
1995. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product was incorrectly tested for
syphilis.
_______________
PRODUCT Red Blood Cells. Recall #B-084-7.
CODE Unit #0347266.
MANUFACTURER Blood Bank of Delaware, Inc., Newark,
Delaware.
RECALLED BY Manufacturer, by telephone on April 6, 1995.
Firm-initiated recall complete.
DISTRIBUTION Delaware.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT Platelets. Recall #B-106-7.
CODE Unit numbers: 0333461, 0353701, 0353703,
0353705, 0353706
MANUFACTURER Blood Bank of Delaware, Inc., Newark,
Delaware.
RECALLED BY Manufacturer, by telephone on June 10, 1995.
Firm-initiated recall complete.
DISTRIBUTION Delaware.
QUANTITY 5 units were distributed.
REASON Blood products were not stored under
continuous agitation.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Ti-Fit (Titanium Stem) Total Hip System,
Femoral Stem, Implantable Orthopedic Devices,
which have not been implanted, under the
following Product Numbers and Lot Numbers:
Domestic Catalogue Numbers/Description
-13- (a) 12-4301/Size 1 Stem, 115 mm Length,
Collared
12-4302/Size 2 Stem, 120 mm Length, Collared
12-4303/Size 3 Stem, 130 mm Length, Collared
12-4304/Size 4 Stem, 140 mm Length, Collared
12-4305/Size 5 Stem, 145 mm Length, Collared
12-4306/Size 6 Stem, 150 mm Length, Collared
12-4307/Size 7 Stem, 155 mm Length, Collared
12-4308/Size 8 Stem, 160 mm Length, Collared
12-4309/Size 9 Stem, 170 mm Length, Collared
916470/Size 2 Stem, 170 mm Length, Collared
916507/Size 1 Stem, 165 mm Length, Collared
(b) 12-4331/Size 1 Stem, 115 mm Length,
Collarless
12-4332/Size 2 Stem, 120 mm Length, Collarless
12-4333/Size 3 Stem, 130 mm Length, Collarless
12-4334/Size 4 Stem, 140 mm Length, Collarless
12-4335/Size 5 Stem, 145 mm Length, Collarless
12-4336/Size 6 Stem, 150 mm Length, Collarless
12-4337/Size 7 Stem, 155 mm Length, Collarless
12-4338/Size 8 Stem, 160 mm Length, Collarless
12-4339/Size 9 Stem, 170 mm Length, Collarless
Foreign Catalog Numbers/Description
(c) 52-4301/Size 1 Stem, 115 mm Length,
Collared
52-4302/Size 2 Stem, 120 mm Length, Collared
52-4303/Size 3 Stem, 130 mm Length, Collared
52-4304/Size 4 Stem, 140 mm Length, Collared
52-4305/Size 5 Stem, 145 mm Length, Collared
52-4306/Size 6 Stem, 150 mm Length, Collared
52-4307/Size 7 Stem, 155 mm Length, Collared
52-4308/Size 8 Stem, 160 mm Length, Collared
52-4309/Size 9 Stem, 170 mm Length, Collared
(d) 52-4331/Size 1 Stem, 115 mm Length,
Collarless
52-4332/Size 2 Stem, 120 mm Length, Collarless
52-4333/Size 3 Stem, 130 mm Length, Collarless
52-4334/Size 4 Stem, 140 mm Length, Collarless
52-4335/Size 5 Stem, 145 mm Length, Collarless
52-4336/Size 6 Stem, 150 mm Length, Collarless
52-4337/Size 7 Stem, 155 mm Length, Collarless
52-4338/Size 8 Stem, 160 mm Length, Collarless
52-4339/Size 9 Stem, 170 mm Length, Collarless
(e) 71971403/Custom made product
71971404/Custom made product
71971405/Custom made product
71971406/Custom made product
71971407/Custom made product
914334/Custom made product.
Recall #Z-135/139-7.
CODES The following lots, all of which were
manufactured prior to October 1994 and shipped
to domestic accounts, are subject to recall:
-14- Seven (7) digit Lot Numbers beginning with the
following:
1U; 2U; 3U; 4U; 1W; 2W; 3W; 4W; 1X; 2X; 3X;
4X; 1Y; 2Y; 3Y; 4Y; 1Z; 2Z; 3Z; 4Z; 1A; 2A;
3A; 4A; 1B; 2B; 3B; 4B; 1C; 2C; 3C; 4C; 1D;
and 2D.
Ten (10) digit Lot Numbers beginning with the
following:
405; 406; 407; 408; and 409
The following lots, all of which were shipped
to foreign accounts, are subject to recall:
1. All lot numbers beginning with the letter
"T" that have only eight (8) digits,
indicating production before 1989; and,
2. All lot numbers beginning with the letter
"T", which have nine (9) or ten (10) digits
and where the sixth digit (which indicates the
year) is smaller than "5"; and,
3. Lots with the sixth digit as a "5" and
beginning with the following digits:
T00465, T00475, T00495, T00505, T00545,
T00745, T01145, T01165, T01245, T02215,
T03665, T03675, T03895, T04795, T04835,
T04845, T04855, T04865, T05725, T05735,
T07875, and T07885 and,
4. Lots with the sixth digit as a "6" and
beginning with the following digits:
T00226, T00236, T00246, T00256, T00266,
T00276, T00286, T00296, T00306, T00316,
T00336, T00346, T00356, T00366, T00376,
T00386, T00396, T01436, T01466, T01496,
T01506, T01516, T03326, T03356, T03436,
T03476, T03976, T06396, and T06406.
MANUFACTURER Smith & Nephew Richards, Inc., Smith & Nephew
Orthopedics, Memphis, Tennessee.
RECALLED BY Manufacturer, by letter on September 26, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,200 systems were distributed.
REASON Laser etching may cause the femoral stems to
fracture in use, requiring revision surgery to
replace the broken hip implant.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Vitros 250 and 950 Reference Fluids, used as a
reference fluid for potentiometric assays on
the Vitros (formerly Ektachem) 950 Chemistry
System and Vitros (formerly Ektachem) 250
Analyzer: (a) Vitros 250, Catalog #176 5304;
(b) Vitros 950, Catalog #805 7812.
Recall #Z-143/144-7.
-15-CODE Lot numbers: (a) M2057; (b) K1423, M1460,
P1492.
MANUFACTURER Johnson & Johnson Clinical Diagnostics,
Rochester, New York.
RECALLED BY Johnson & Johnson Clinical Diagnostics,
Rochester, New York, by letter dated September
30, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 1,952 boxes (30 units per box); (b) 3,833
boxes (30 units per box) were distributed.
REASON A portion of these lots had a diluted
electrolyte concentration that could result in
a shift in the sodium and chloride results.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ========
_______________
PRODUCT Tribrissen 480 Tablets, in 100 and 200 tablet
bottles, Rx veterinary synthetic
antibacterial. Recall #V-019-7.
CODE Lot numbers: 002972, 003092, 003181.
MANUFACTURER Mallinckrodt Veterinary, Inc., Bray, Ireland.
RECALLED BY Mallinckrodt Veterinary, Inc., Mundelein,
Illinois, by letter dated September 3, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 702 bottles were distributed.
REASON The bottle labels for both sizes contained a
typographical error. Trimethoprim was listed
at 80g strength instead of 80 mg strength.
_______________
PRODUCT TM-50 (oxytetracycline) Type A Medicated
Article, in 50 pound bags. Recall #V-020-7.
CODE Lot numbers FPX9X25 and FP10X25.
MANUFACTURER Farmland Industries, Inc., Eagle Grove, Iowa.
RECALLED BY Farmland Industries, Inc., Kansas City,
Missouri, by telephone on August 9, 12-13,
1996, followed by letter on September 16,
1996. Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 160 bags were distributed.
REASON Product failed 12 month stability testing.
-16-
END OF ENFORCEMENT REPORT FOR NOVEMBER 27, 1996. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
![[FDA HOME PAGE]](/icon/iconhome.gif)