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.
January 14, 1998 98-02
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Ice Cream: a) Dreyer's brand Cookies'N Cream
Ice Cream Bars; b) Cascadian Farm brand
Organic Brownie Bar Vanilla Ice Cream and
Chocolate Brownie; c) Safeway Select brand
Coffee Almond Ice Cream Bars.
Recall #F-217/219-8.
CODE a) 071835 and 071895; b) 072005; c) 072315.
MANUFACTURER Americana Foods, Dallas, Texas.
RECALLED BY Manufacturer, by telephone beginning October
15, 1997. Firm-initiated recall ongoing.
DISTRIBUTION California, Illinois, Texas, New York,
Georgia, Florida, Ohio, Arkansas, Kansas,
Maryland, Oregon, Washington state.
QUANTITY 29,814 cases were distributed.
REASON Products may be contaminated with Listeria
Monocytogenes.
_______________
PRODUCT Golden Lion brand Dry Sweet Mongo (Mango), in
7 ounce plastic bags, imported from China.
Recall #F-220-8.
CODE None.
MANUFACTURER Taishan City Huafeng Food Company, China.
RECALLED BY Blooming Imports, Inc., Brooklyn, New York, by
letter dated March 20, 1997, followed by
telephone. Completed recall resulted from
sample analysis and followup by the New York
Department of Agriculture and Markets.
DISTRIBUTION New York and New Jersey.
QUANTITY 50 cases (50 packages per case) were
distributed.
REASON Product contains undeclared sulfites and
undeclared tartrazine (certifiable as FD&C
Yellow No. 5).
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
UPDATE The correct recall number for Chile Flavored
Corn Stixs (Mexsnax Corn Churritos de Maiz) 5
and 7 ounce sizes is F-186-8. This recall was
published in the December 17, 1997 Enforcement
Report as F-140-8.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
II ============
_______________
PRODUCT Thyrolar 2 Tablets (Levothyroxine 100
mcg/Liothyronine 25 mcg), in 100 tablet
bottles, Rx, used as a synthetic thyroid
replacement therapy. NDC #0456-0055-01.
Recall #D-058-8.
CODE Lot #1975 EXP 12/98.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati,
Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis,
Missouri, by letter on November 24, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,044 bottles were distributed.
REASON Mislabeling - One bottle labeled as containing
Thyrolar 2 was found to contain Thyrolar 1
Tablets.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Royal Med brand (a) Enteric Coated Aspirin
Tablets, 325 mg, in 100 tablet bottles; b)
Acetaminophen Tablets, 325 mg, in 100 tablet
bottles, OTC products used for the temporary
relief of minor aches, pains, and headaches,
and to reduce fever. Recall #D-060/061-8.
CODE Lot #101G45 EXP 5/99.
MANUFACTURER Geri-Care Pharmaceutical Corporation,
Brooklyn, New York.
RECALLED BY Manufacturer, by letter dated December 16,
1997, followed by telephone. Firm-initiated
recall ongoing.
DISTRIBUTION Minnesota, California, Florida Georgia,
Illinois, Massachusetts, Ohio, Pennsylvania,
Texas, Washington state.
QUANTITY a) 384 bottles; b) 2,821 bottles were
distributed.
REASON Mislabeling - Some bottles labeled as enteric
coated aspirin contain acetaminophen.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Source Plasma. Recall #B-284-8.
CODE Unit numbers: 78917552, 78734883.
MANUFACTURER NABI BioMedical Center, Spokane, Washington.
RECALLED BY NABI, Boca Raton, Florida, by letter dated
April 21, 1997. Firm-initiated recall
complete.
DISTRIBUTION Korea.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
who tested EIA positive for anti-HCV.
_______________
PRODUCT Red Blood Cells. Recall #B-316-8.
CODE Unit #N89142.
MANUFACTURER Lifeblood/Mid-South Regional Blood Center,
Memphis, Tennessee.
RECALLED BY Manufacturer, by letter on February 14, 1996.
Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of Hashimoto Disease.
_______________
PRODUCT Platelets, Pheresis. Recall #B-392-8.
CODE Unit #55V06957.
MANUFACTURER American Red Cross Blood Services, Little
Rock, Arkansas.
RECALLED BY Manufacturer, by telephone on November 4,
19997, and by letter dated November 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that
compromises the sterility of the unit.
_______________
PRODUCT a) Red Blood Cells; b) Platelets, Pheresis.
Recall #B-409/410-8.
CODE Unit numbers: a) 4166898, 4166920, 4166946
b) 4166893, 4166896, 4166897, 4166904,
4166905, 4166913, 4166917, 4166919, 4166934,
4166947, 4166949, 4166958, 4166964, 4166973,
4166991, 4166997.
MANUFACTURER Central Texas Regional Blood & Tissue Center,
Austin, Texas.
RECALLED BY Manufacturer, by letter dated September 12,
1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY a) 3 units; b) 16 units.
REASON Blood products, incorrectly tested for
anti-HBc, were distributed for transfusion.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
c) Recovered Plasma. Recall #B-411/413-8.
CODE Unit numbers: a) 18208-6018 and 18211-3292
b) 18208-6018; c) 18211-3292.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated May 16, 1997. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Wyoming, Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit.
REASON Blood products were collected from a donor
with a history of hepatitis A.
_______________
PRODUCT a) Red Blood Cells; b) Platelets, Pheresis.
Recall #B-417/418-8.
CODE Unit numbers: a) 3320001, 3320012, LC60203,
LC60216; b) 0305545A, 0305545B, 0305544B.
MANUFACTURER Inland Northwest Blood Center, Spokane,
Washington.
RECALLED BY Manufacturer, by letter dated September 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Washington state and Idaho.
QUANTITY a) 4 units; b) 3 units.
REASON Blood products, for which documentation of
irradiation was incomplete, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-419-8.
CODE Unit #49S71897.
MANUFACTURER American Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letter dated September 22.
1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
diagnosed with Sarcoidosis.
_______________
PRODUCT Recovered Plasma. Recall #B-422-8.
CODE Unit #53GL92860.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated September 25,
1997. Firm-initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of hepatitis.
_______________
PRODUCT a) Red Blood Cells, Leukocytes Removed
b) Cryoprecipitated AHF
c) Plasma. Recall #B-423/425-8.
CODE Unit #53FH64207.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on September 25,
1997, and by letter dated October 14, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
had body piercing within twelve months of
donation and engaged in high risk behavior.
_______________
PRODUCT a) Red Blood Cells. Recall #B-426-8.
CODE Unit #53R53939.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on September 17,
1997, and by letter dated September 22, 1997.
Firm-initiated recall comlete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor
whose body temperature was determined to have
been inaccurately documented.
_______________
PRODUCT a) Whole Blood; b) Red Blood Cells
c) Platelets; d) Pooled Platelets
e) Recovered Plasma. Recall #B-428/432-8.
CODE Unit numbers: a) LX45872
b) R99750, LW46794, LW51845, Q70573,
LN02558, LN02569, LG94129, LS07668, Q70715
c) T43173; d) FP72530 (includes Platelets,
unit LS07668), and FP72556 (includes
Platelets, unit Q70715)
d) LN02610, Q70715, and FP72556.
MANUFACTURER The Blood Center of Southeastern Wisconsin,
Inc. Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by telephone starting April 29,
1997. Firm-initiated recall complete.
DISTRIBUTION Wisconsin, California, New Jersey,
Switzerland.
QUANTITY a) 1 unit; b) 9 units; c) 1 unit;
d) 2 units; e) 3 units.
REASON Blood products, which tested either: 1)
repeatedly reactive for the HIV-1 p24 antigen;
2) repeatedly reactive for the antibody to the
hepatitis B core antigen (anti-HBc); 3)
repeatedly reactive for the antibody to the
hepatitis C virus encoded antigen (anti-HCV);
4) repeatedly reactive for the antibody to the
human T-lymphotropic virus type I
(anti-HTLV-I); 5) had an elevated ALT; or 6)
tested repeatedly reactive for anti-HBc, HCV,
and had an elevated ALT.
_______________
PRODUCT Red Blood Cells. Recall #B-435-8.
CODE Unit #H11629.
MANUFACTURER Northern Illinois Blood Bank, Rockford,
Illinois.
RECALLED BY Manufacturer, by letter dated October 30,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
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 a) Red Blood Cells;
b) Cryoprecipitated AHF.
Recall #B-436/437-8.
CODE Unit #V08035.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letter dated December 19,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois and Florida.
QUANTITY 1 unit of each component was 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
indeterminate.
_______________
PRODUCT Platelets, Pheresis. Recall #B-441-8.
CODE Unit #3197571.
MANUFACTURER Gulf Coast Regional Blood Center,
Houston, Texas.
RECALLED BY Manufacturer, by letter dated July 31,1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of cancer.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-420-8.
CODE Unit #49S71897.
MANUFACTURER American Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letter dated September 22,
1997. Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
having been diagnosed with Sarcoidosis.
_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Fresh Frozen Plasma.
Recall #B-414/416-8.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance 301)
827-6220 for individual unit numbers recalled.
MANUFACTURER Texoma Regional Blood Center, Sherman, Texas.
RECALLED BY Manufacturer, by letter dated August 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas, Florida, California, Massachusetts.
QUANTITY a) 34 units; b) 22 units; c) 12 units.
REASON Blood products were prepared greater
than 8 hours after collection of the Whole
Blood units.
_______________
PRODUCT Buffy Coat. Recall #B-421-8.
CODE Unit #3141899.
MANUFACTURER Gulf Coast Regional Blood Center, Houston,
Texas.
RECALLED BY Manufacturer, by letter dated June 6, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
tested PK-TP reactive for syphilis.
_______________
PRODUCT a) Recovered Plasma. Recall #B-427-8.
CODE Unit #53R53939.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter on September 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
body temperature was determined to have been
inaccurately documented.
_______________
PRODUCT Recovered Plasma. Recall #B-433-8.
CODE Unit numbers: LS07668 and FP72530.
MANUFACTURER The Blood Center of Southeastern Wisconsin,
Inc. Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by telephone starting April 29,
1997. Firm-initiated recall complete.
DISTRIBUTION California, New Jersey, Switzerland.
QUANTITY 2 units were distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the human T-lymphotropic virus
type I (anti-HTLV-1), Western blot negative.
_______________
PRODUCT Red Blood Cells. Recall #B-434-8.
CODE Unit numbers: 29447-0299, 29447-1599.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on November 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.
_______________
PRODUCT a) Autologous Red Blood Cells; b) Autologous
Liquid Plasma.
Recall #B-438/439-8.
CODE Unit #H21429.
MANUFACTURER Northern Illinois Blood Bank, Rockford,
Illinois.
RECALLED BY Manufacturer, by telephone on September 22,
1997, and by letter dated October 30, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products, which tested repeat reactive
for syphilis, were distributed without
Biohazard labels.
_______________
PRODUCT Red Blood Cells. Recall #B-440-8.
CODE Unit #1754585.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone on November 5,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested Jk(b-) was distributed
labeled as Jk(a-).
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT CA-300 Face Mask, Adult Medium, single use, an
accessory to the Aerotech I Aerosol Unit for
the Administration Technetium Tc 99m
(radioactive agent) for lung imaging.
Recall #Z-251-8.
CODE Lot #0287300.
MANUFACTURER Engineered Medical Systems (EMS),
Indianapolis, Indiana.
RECALLED BY CIS-US, Inc., Bedford, Massachusetts, by
letter dated October 14, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Sweden.
QUANTITY 1,054 masks were distributed.
REASON Some of the masks may have a seal defect where
the plastic mold joins the apex at the plastic
nosepiece, resulting in a small hole.
_______________
PRODUCT Microventricular Pressure Monitoring Kits:
a) Model 110-4H; b) 110-4HC.
Recall #Z-252/253-8.
CODE Sterile lot codes 07-25-97, 08-01-97, and
08-22-97.
MANUFACTURER Camino NeuroCare Group, San Diego, California
(device); Allied Swiss, Oceanside, California
(component).
RECALLED BY NeuroCare Group. San Diego, California, by
telephone on September 24, 1997, followed by
letter dated September 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia, Illinois, Florida, Michigan,
Missouri, Arkansas, Nevada, California,
Alaska, Georgia, New York, Maryland, Ohio,
Idaho, Oregon, Canada.
QUANTITY 134 units were distributed.
REASON The plastic bolt cap which secures the
catheter to the stainless steel bolt does not
have threads.
_______________
PRODUCT Ultrasound Transmission Gel, in 8 fluid ounce
containers, used to provide an efficient sound
coupling medium for ultrasound transmission.
Recall #Z-254-8.
CODE Part #82-299, Lot #53428 EXP 8/98.
MANUFACTURER Aplicare, Inc. (Previously known as Redi
Products, Inc., Pritchard, West Virginia.
RECALLED BY Manufacturer, by verbally contacting all
customers on November 21, 1997, followed by
letter dated November 24, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 64 cases were distributed.
REASON There was mold growing between the nozzle and
the nozzle cap of the applicator.
_______________
PRODUCT Model Epilaser System, used in dermatology.
Recall #Z-255-8.
CODE None.
MANUFACTURER Palomar Medical Products, Inc., Lexington,
Massachusetts.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on December 22, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 89 units were distributed.
REASON The safety shutter hung open, potentially
exposing users and patients to unnecessary
laser radiation.
_______________
PRODUCT Radiation Protective Devices:
a) Thyroid Shield;
b) Thyroid Flare;
c) Maternity Shield;
d) Aprons (One piece, two piece, half and
mini); e) Vest; f) Kilt; g) Apron Sleeve;
h) Lead Drape;
i) Fluoroscopic Spot Film Shield;
j) Table Mounted Radiation Shield (Lead vinyl
Shields only);
k) Port Shield/Port Shield X-tra and
replacement shields.
Recall #Z-259/269-8.
CODE None.
MANUFACTURER AADCO Medical, Inc., Randolph, Vermont.
RECALLED BY Manufacturer, by letter December 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Brazil, Hong Kong
QUANTITY 700 units were distributed.
REASON The radiation protection devices contain lead
contaminated with small amounts of radioactive
substances.
_______________
PRODUCT Signature 1385A-04 (Custom) Perfusion Pack,
made specifically for Enloe Memorial Hospital,
Chico, California, and is a perfusion set for
heart bypass surgery.
Recall #Z-258-8.
CODE Signature lot numbers CP97H20P and CP97I30M
are affected. Lot CP97H20P contains Bard
H-130 Over Pressure Safety Valves from lot
43CHV108, and lot CP97I30M contains valves
from Bard lot 43CHV111.
MANUFACTURER Avecor Cardiovascular, Inc., Minneapolis,
Minnesota.
RECALLED BY Manufacturer, by letter faxed on November 11,
1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 63 units were distributed
REASON Valve can become occluded preventing blood
flow through valve.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT dsDNA IgG/M Enzyme-Linked Immunosorbent Assay
(ELISA), for the detection of antibodies in
human serum to dsDNA antigen and as an aid in
diagnosis of systemic lupus erythematosus.
For in vitro diagnostic use, 96 determinations
per kit, labeled as follows: Wampole
Laboratories, Product #427670 (domestic) and
Clark Laboratories, Product #2327670
(International). Recall #Z-250-8.
CODE Lot No. 041.
MANUFACTURER Trinity Biotech (formerly Clark Laboratories,
Inc.), Jamestown, New York.
RECALLED BY Manufacturer, by telephone and by letter dated
December 2, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION New Jersey, South Africa, Australia.
QUANTITY 276 kits were distributed.
REASON The absorbance of the positive control falls
below its stated range on the vial label.
_______________
PRODUCT OPTIMA FW (Polymacon) Visibility Tinted
Contact Lenses, 6-Packs & Value Packs, -3.5
8.7mm BC. Recall #Z-256-8.
CODE Lot 7120C1AA EXP 04/2000.
MANUFACTURER Bausch & Lomb, Inc., Rochester, New York.
RECALLED BY Manufacturer, by letter dated October 20,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,604 lensses were distributed.
REASON Some of the blister packs may contain lenses
with the incorrect refractive power of -1.25D.
_______________
PRODUCT Restore 3.75 mm X 15 mm RD Threaded RBM
Implant w/Mount, Catalog #R9050-38-15, a
dental implant used as a basis for a
replacement tooth. Recall #Z-257-8.
CODE Lot number 75981021.
MANUFACTURER Lifecore Biomedical, Inc., Chaska, Minnesota.
RECALLED BY Manufacturer, by telephone on December 17,
1997. Firm-initiated recall complete.
DISTRIBUTION California, Montana, Nevada, New York, Japan.
QUANTITY 32 implants were distributed.
REASON The patient chart label, which was placed on
the cap of each outer vial holding the
product, mis-states the size of the implant as
being 3.75 mm X 7 mm. The correct size is
3.75 mm X 15 mm. The device label on the side
of the outer product vial, and the secondary
label on the inner vial are both correct.
_______________
PRODUCT Bartels Epstein-Barr Virus IgG Enzyme
Immunoassay, intended for the qualitative
detection of IgG antibody to the viral capsid
antigen (VCA) of Epstein-Barr Virus in human
serum by the enzyme-linked immunosorbent assay
(ELISA) method. Recall #Z-270-8.
CODE Lot #2101.
MANUFACTURER Gull Laboratories, Salt Lake City, Utah.
RECALLED BY Bartels, Inc., the Diagnostics Division of
Intracel Corporation, Issaquah, Washington, by
letter on December 16, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION California, Delaware, Iowa, Ohio,
Pennsylvania, Puerto Rico, Texas, Washington
state.
QUANTITY 91 kits were distributed.
REASON The conjugate is losing stability resulting in
absorbance values for the reference and
positive control that are lower than the
limits specified in the product insert.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I ============
_______________
PRODUCT Medicated Sheep feed:
a) Nutrena 41% Lamb Concentrate Medicated
b) Nutrena Lamb Kwik 2 Concentrate Medicated
c) Nutrena Lamb-Care Creep Feed Medicated
d) Bulk Walnut Grove Lamb 33%/BOV Medicated
Feed to Growing and Finishing Lambs - Bulk
Feed
e) Nutrena Pipestone Lamb Pellet Medicated.
Recall #V-001/005-8.
CODE Lot numbers: a) Y7T-213 & Y7T-155
b) Y7T-205, Y7T202 Y7T-154 and Y7T-178
c) Y7T-232; d) Bulk Feed; e) Y7T-136.
MANUFACTURER Cargill, Inc., Animal Nutrition Division,
Sioux City, Iowa.
RECALLED BY Manufacturer, by telephone on October 3,
1997. Firm-initiated recall complete.
DISTRIBUTION a) Iowa, South Dakota, Nebraska
b) South Dakota; c) South Dakota and Iowa
d) Iowa; e) Minnesota.
QUANTITY a) 707 50-pound bags, and 10,120 pounds
b) 365 50-pound bags; c) 81 6-pound bags
d) 2 26-ton batches; e) 78 50-pound bags were
distributed.
REASON The medicated sheep feeds contained high
levels of copper.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ==========
_______________
PRODUCT Albon (sulfadimethoxine) Bolus for the
treatment of shipping fever complex and
bacterial pneumonia. Recall #V-007-8.
CODE Lot #148285070 EXP 6-02.
MANUFACTURER Pfizer, Inc., Animal Health Group,
Lincoln, Nebraska.
RECALLED BY Manufacturer, by letter on November 6, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, Kentucky, Tennessee, Mississippi,
Louisiana,Oklahoma, Arkansas, Wisconsin,
Missouri, Ohio, Colorado and South Dakota.
QUANTITY 290 bottles (50 boluses per bottle)
were distributed.
REASON The product developed mold.
_______________
PRODUCT Purina Catfish Chow Dense Culture Ro Medicated
(sulfadimethoxine and ormetoprim) for the
control of Enteric Septicemia infections of
catfish. Recall #V-008-8.
CODE P316-G2 and P376-F8.
MANUFACTURER Purina Mills, Inc., St. Louis, Missouri.
RECALLED BY Manufacturer, by either letter or telephone
on August 19, 1997. Firm-initiated recall
complete.
DISTRIBUTION Mississippi, Georgia, Alabama, North Carolina.
QUANTITY 599 50-pound bags were distributed.
REASON Product was subpotent - 33% of label
guarantee of sulfadimethoxine and ormetoprim.
_______________
PRODUCT Fermenta Veterinary Products Neurosyn
(primidone) for the control of convulsions in
dogs. Private Labels: Vetus Animal Health
Primitabs; Butler Primidone; Vedco Primidone
Tablets; WV Primidone Tablets.
Recall #V-009-8.
CODE 057ZP05 and 057ZP06 - EXP May 2000.
MANUFACTURER Boehringer Ingelheim Animal Health, Inc.,
Elwood, Kansas.
RECALLED BY Boehringer Ingelheim Animal Health, Inc., St.
Joseph, Missouri, by letters on October 8 and
23, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Texas, Florida, Illinois, Georgia, Nevada,
Washington state, Missouri, Ohio.
QUANTITY 840/1,000 tablet bottles (lot # 057ZP05) and
4,896/100 tablet bottles (lot # 057ZP06).
REASON Product failed dissolution testing.
END OF ENFORCEMENT REPORT FOR JANUARY 14, 1998. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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