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.
October 15, 1997
97-42
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Albertson's Ice Cream:
a) Albertson's Brownie Sinsation Light Ice Cream;
b) Albertson's
Mocha-Mocha Light Ice Cream; c) Albertson's Chunky
Chocolate Ice Cream. Recall #F-027/029-8.
CODE a) Expiration date of 11/21/97,
b) Expiration date of 11/21/97,
c) Expiration date of 01-15-98.
MANUFACTURER Alta Dena Certified Dairy, Inc., City of Industry,
California.
RECALLED BY Manufacturer, by telephone on September 9, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California and Arizona.
QUANTITY 11,110 half-gallon units were distributed.
REASON Products contain undeclared peanut protein.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT a) Mehadir Smoked Rainbow Trout; b) Mehadir Smoked
Rainbow Trout Peppered.
Recall #F-004/005-8.
CODE None.
MANUFACTURER Salmolux Inc., Federal Way, Washington.
RECALLED BY Mehadrin Dairy Corporation, Brooklyn, New York
(distributor), by letter April 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Undetermined.
QUANTITY a) 2,857 packages; b) 1,275 packages were
distributed.
REASON Product contains sodium nitrite, and there is
no food additive regulation authorizing the use
of sodium nitrite in Smoked Rainbow Trout.
_______________
PRODUCT Gelatin 21 ounces, manufactured for Fiesta Mart
& H-E-B:
a) Strawberry-Lime Gelatin manufactured for
Fiesta Mart
b) Sugar Free Cherry-Lime Gelatin manufactured
for H-E-B. Recall #F-006/007-8.
CODE DEC 15 1997 and DEC 30 1997
MANUFACTURER Bela Corporation, San Antonio, Texas.
RECALLED BY Manufacturer, by telephone on September 3, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Texas.
QUANTITY a) 504 cases; b) 2,184 cases were distributed.
REASON The product contains undeclared FD&C Yellow No.5.
_______________
UPDATE Recall #F-814-7, Betty Crocker Brand Red Sugar
in 3 ounce canisters, product number 71103,
codes D724, E707, E708 and E713A, which appeared
in the September 24, 1997, Enforcement Report IS
NOT A RECALL BUT RATHER A "STOCK RECOVERY".
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT Hair Removal Cream labeled "The Art of Beauty
Epil-Stop Hair Removal Cream, 4 oz."
Recall #F-026-8.
CODE C250, C252, C253, C260, C263, C264, and C267
- Lot numbers are stamped on the bottom of the
jar - all lots have an expiration date of 8/99.
MANUFACTURER International Chemical Corporation, Amherst,
New York.
RECALLED BY Manufacturer, by undated letters sent by
September 13, 1997.
State of California Poison Control Office issued
press release on September 4, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 20,000 units were distributed.
-2-
REASON Product is adulterated in that it has high pH
levels which may cause skin irritation and
burning.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
II
===========
_______________
PRODUCT Triaminic Night Time Maximum Strength, Nasal
Decongestant,
Cough Suppressant, Antihistamine, Grape Flavor,
OTC, in 4 fluid ounce plastic bottles. Recall
#D-008-8.
CODE Lot #22905.
MANUFACTURER Novartis Consumer Health, Inc., Lincoln, Nebraska.
RECALLED BY Novartis Consumer Health, Inc., Summit, New
Jersey, by telephone on September 23, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nebraska and Pennsylvania.
QUANTITY 31,938 bottles were distributed.
REASON Possible compressor oil contamination.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Hycamtin Injection (Topotecan HCl), in 4 mg/5 ml
vials, packaged in units of 5, an anti-neoplastic
for the treatment of ovarian cancer.
Recall #D-001-8.
CODE Lot #2016H01 EXP 10/31/97.
MANUFACTURER Smith Kline Beecham Pharmaceuticals, Conshohocken,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated May 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that between 10-15 units remained
on market at time of recall initiation.
REASON Product exceeded degradation limits at 9 month
stability testing and displayed discoloration.
_______________
PRODUCT Infant's Simethicone Drops, in 1 fluid ounce
units, OTC, for relief of gas symptoms,
antiflatulent, Made in the USA for Qualitest
Products, Inc..
Recall #D-003-8.
CODE Lot No. 005B7A, EXP 2/99.
MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville,
Alabama.
RECALLED BY Manufacturer, by letters dated August 4
and 21, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama.
QUANTITY 4,548 cartons were distributed.
-3-
REASON Product released without tamper evident neck band.
_______________
PRODUCT Clonidine HCL Tablet USP, Rx: a) 0.1mg; b) 0.2mg;
c) 0.3mg, a single ingredient tablet, packaged in
100 and 1000 tablet bottles.
Recall #D-004/006-8.
CODE Lot numbers: a) (100's) 85680, 83006, 88372
(1000's) 82497, 83006, 85680, 89883
b)(100's) 87679, 87930, 88598, 88847
(1000's) 87679, 87930, 88598, 88847
c)(100's) 87784, 87785, 87931, 88848, 89887.
MANUFACTURER Geneva Pharmaceuticals, Inc. Broomfield, Colorado.
RECALLED BY Manufacturer, by letter on September 10-11, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 5,300,000 tablets; b) 2,300,000 tablets;
c) 7,000,000 tablets were distributed.
REASON Product is subpotent at 24 month stability testing
(2 lots) and/or an atypical decrease in potency
after release (12 lots).
_______________
PRODUCT Oxygen U.S.P. in M-6 and E high pressure cylinders
dispensed by prescription. Recall #D-007-8.
CODE 12179601, 03129701, 03139701, 04199701, 04239701,
04259701, 05169701, 05289701, 06119701, 06139701,
07019701, 07189701, 07219701, 07229701, 08139701,
08149701 and 09099701.
MANUFACTURER Lamberson's Home Care, Inc., Duluth, Georgia.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
ongoing.
DISTRIBUTION Georgia.
QUANTITY 20 E cylinders and 10 m-6 cylinders were
distributed.
REASON Assay records indicated subpotency.
_______________
PRODUCT Trazodone HCl Tablets, USP, 50 mg, unit dose
packaged as 10 cards of 10 unit dose tablets per
shelf carton, Rx antidepressant.
Recall #D-009-8.
CODE Lot #7F837 EXP 3/99.
MANUFACTURER Purepac Pharmaceutical Company, Elizabeth, New
Jersey.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois,
by letter dated September 25, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
-4-
QUANTITY 8,481 unit cartons were distributed.
REASON Some shelf cartons may be labeled as containing
propranolol HCl Tablets 40 mg. (The unit dose
and product insert labeling is correct).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma.
Recall #B-1026/1028-7.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 594-1191
for individual unit numbers recalled.
MANUFACTURER United Blood Services, Fort Smith, Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated July 3, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Arkansas, Alabama, Louisiana, Mississippi,
Oklahoma, Texas.
QUANTITY a) 241 units; b) 188 units; c) 261 units were
distributed.
REASON Blood Products were collected from donors who
may have been exposed to one or more tick-borne
pathogens prior to their donation of blood.
_______________
PRODUCT Red Blood Cells. Recall #B-1310-7.
CODE Unit numbers: R02833, R16013.
MANUFACTURER Marsh Regional Blood Center, Kingsport, Tennessee.
RECALLED BY Manufacturer, by letter sent on February 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION Tennessee and Virginia.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
with a history of skin cancer.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1338/1339-7.
CODE Unit #28KG32486.
MANUFACTURER American Red Cross Blood Services, Savannah,
Georgia.
RECALLED BY Manufacturer, by telephone on April 28, 1997,
followed by letter on May 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
taking the drug Proscar.
-5-
_______________
PRODUCT Red Blood Cells. Recall #B-1353-7.
CODE Unit numbers: 40FY19073, 40LY00503.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on July 4, 1997,
followed by letters on July 10 and 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois and New Jersey.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
who reported travel to an area designated as
endemic for malaria.
_______________
PRODUCT a) HIV-1/HIV-2 EIA Test Kits;
b) HBsAg EIA 2.0 Test Kits.
Recall #B-1487/1488-7.
CODE Lot numbers: a) 087PR1-10, 092PR1-05;
b) 091PM1-50.
MANUFACTURER Genetic Systems Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by telephone and fax between April
17, 1997, and May 14, 1997. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Kentucky, North Dakota, New Jersey,
Ohio, Tennessee, Texas.
QUANTITY 71 kits were distributed.
REASON Genetic Systems in-vitro diagnostic kits contained
unprocessed microtiter well plates and were
distributed.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma.
Recall #B-1500/1502-7.
CODE Unit numbers: 5053574, 5059137.
MANUFACTURER LifeSource Blood Services, Glenview, Illinois.
RECALLED BY Manufacturer, by letters dated August 6 and 8,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor taking
the drug Proscar.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1514/1515-7.
CODE Unit #17029-1371.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated June 11, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas.
-6-
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
was previously deferred for self-exclusion.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-001/002-8.
CODE Unit #03GJ42006.
MANUFACTURER American Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on July 23, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
taking the drug Proscar.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-003/004-8.
CODE Unit numbers: 20FM00696 and 20FM03227.
MANUFACTURER American Red Cross Blood Services, Boise, Idaho.
RECALLED BY Manufacturer, by letter dated May 5, 1997.
Firm-initiated recall complete.
DISTRIBUTION Montana.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor with
a history of cancer.
_______________
PRODUCT Red Blood Cells. Recall #B-005-8.
CODE Unit #21GY31210.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated August 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
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 Source Plasma. Recall #B-006-8.
CODE Unit #K46027.
MANUFACTURER Marion Plasma Company, Inc., Salem, Oregon.
RECALLED BY Manufacturer, by fax on March 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
who previously confirmed positive for syphilis.
-7-
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-007/008-8.
CODE Unit #28108-6496.
MANUFACTURER United Blood Services, San Angelo, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on July 25,1997, and by letter dated
August 20, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
who had been incarcerated.
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma; d) Recovered Plasma.
Recall #B-009/012-8.
CODE Unit numbers: a) 17023-1636, 17030-9520;
b) 17030-9520; c) 17030-9520; d) 17023-1636.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems,Inc., Scottsdale, Arizona, by
letter dated June 11, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas and North Carolina.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit was
distributed.
REASON Blood products were collected from a donor who
was deferred for a history of hepatitis, liver
disease, or a positive test for hepatitis.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-013/014-8.
CODE Unit numbers: a) 4723946, 4750957, 4776435;
b) 4750957.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by fax and letters
dated January 22, 1997, or February 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY a) 3 units; b) 1 unit was distribution.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-015-8.
CODE Unit #KQ29853.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on June 6, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
-8-
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported high risk behavior, was distributed
after receipt of this information.
_______________
PRODUCT Platelets. Recall #B-016-8.
CODE Unit #4884179.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by telephone on May 6, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
who reported accidental needlesticks.
_______________
PRODUCT Red Blood Cells. Recall #B-017-8.
CODE Unit #12GH81086.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by telephone on July 24, 1997,
and by letter on July 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported travel to an area designated as
endemic for malaria.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT a) Platelets; b) Recovered Plasma.
Recall #B-1311/1312-7.
CODE Unit numbers: R02833, R16013.
MANUFACTURER Marsh Regional Blood Center, Kingsport, Tennessee.
RECALLED BY Manufacturer, by letter on February 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION California and Maryland.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor with
a history of skin cancer.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=========
_______________
PRODUCT Althin Drake Willock System 1000 Dialysis Delivery
System, used to provide dialysate at the
prescribed temperature and ionic concentration to
be used for hemodialysis treatment.
Recall #Z-709-7.
-9-
CODE Serial numbers: 1027-8613 (non-inclusive).
MANUFACTURER Althin Medical, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by letter issued during the week
of May 26, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION International.
QUANTITY 751 units were distributed.
REASON Blood pump stop alarm may not occur if the
blood pump head is jammed.
_______________
PRODUCT Althin Drake Willock System 1000 Dialysis
Delivery System, used to provide dialysate at
the prescribed temperature and ionic
concentration to be used for hemodialysis
treatment. Recall #Z-710-7.
CODE All units distributed until May 22, 1997.
MANUFACTURER Althin Medical, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by issuing a product safety
mailing between April 18 and 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION International.
QUANTITY Approximately 8,800 units were distributed.
REASON Potential for air in the blood line.
_______________
PRODUCT a) Hyperion Hydrophilic Wound Gel, 1 ounce
foil pouch, Product No. 6010, Hyperion Hydrophilic
Wound Dressing 2 X 2 Gauze, Product No. 6022;
b) Hyperion Hydrophilic Wound Dressing 4 X 4
Gauze, Product No. 6044. The gel is placed on an
open wound and the Wound dressing is placed over
the gel to aid in the healing of peptic ulcers
(stages I-IV), stasis ulcers, 1st and 2nd degree
burns, cuts and minor irritations of the skin.
Recall #Z-892/893-7.
CODE All lot numbers labeled as "sterile" are under
recall.
MANUFACTURER Hyperion Medical, Orlando, Florida.
RECALLED BY Manufacturer, by letter on August 5, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 876 units were distributed.
REASON Lack of adequate validation to assure sterility.
_______________
PRODUCT Reclining Geriatric Chairs, Models 520, 521,
525, 526, 130, a mobile (with lockable casters)
adjustable reclining chair used with geriatric
patients in an institutional setting (nursing
homes). Recall #Z-899/903-7.
-10-
CODE For models 130 and 150, serial numbers 103393
to 107200; for model #521, serial numbers 101602
to 103009; for model #525 serial number 100965
to 101575; and for model #526 serial numbers
100099 to 100356.
MANUFACTURER:Winco, Inc., Ocala, Florida.
RECALLED BY Manufacturer, by letter on August 6, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 3,000 units may still be in use.
REASON Plastic seat bracket may break causing patient
fall.
_______________
PRODUCT Bartels Clostridium difficile Toxin A Enzyme
Immunoassay, in-vitro diagnostic product.
Recall #Z-009-8.
CODE Catalog No. B1029-69, Lot Nos. 7E425, 7E426,
7F227, 7F228, 7F229, 7F350, 7F351, 7F352,
7F353, and 7G113.
MANUFACTURER Bartels, Inc., Issaquah, Washington.
RECALLED BY Manufacturer, by letter dated August 11, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 364 were distributed.
REASON Device gives a higher than normal rate of
indeterminate and positive results because of
cross-reactivity between the conjugate and the
specimen treatment buffer.
_______________
PRODUCT Portable Oxygen Monitor, Model No. TED 200-T.
Recall #Z-010-8.
CODE Lot numbers: 158792, 158793, 158794, 158795,
158796, 157899, 158800, 158803, 158804, 158805,
158806, 158807, 158809, 158810, 158811, 158813,
158814, 158815, 158816, 158817, 158829, 158830,
and 158841.
MANUFACTURER Teledyne Analytical Instruments, City of Industry,
California.
RECALLED BY Manufacturer, by telephone and/or fax on June 27,
1996, followed by fax, and letters mailed to each
account on June 28, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and the United Kingdom.
QUANTITY 23 units were distributed.
REASON Metalized paint chips flaking into instrument
may cause a short circuit.
-11-
END OF ENFORCEMENT REPORT FOR OCTOBER 15, 1997. BLANK PAGES
MAY FOLLOW.
####
End of Enforcement Report for
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