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.
February 25, 1998 98-08
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Potato Salad, in 10 pound bulk containers, 3
pound tubs, 1.5 pound tubs, and 1 pound tubs,
under the Sandridge and Meijers labels.
Recall #F-258-8.
CODE Retail containers coded with "USE BY" dates of
"JAN 4 BA", "JAN 4 BB", and "JAN 4" and bulk
containers with "USE BY" date of "1 4 BX".
MANUFACTURER Sandridge Gourmet Salads, Medina, Ohio.
RECALLED BY Manufacturer, by press release on December 24,
1997, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, Wisconsin, Minnesota, Michigan,
Ohio, Kentucky, New York, Colorado, Indiana.
QUANTITY 15,614 pounds were distributed.
REASON The potato salad may be contaminated with
Listeria monocytogenes.
_______________
PRODUCT Market Basket Brand, Fresh Baked Pies:
a) Apple Pie (8 inch and 10 inch sizes)
b) Blueberry Pie (8 inch and 10 inch sizes)
c) Lattice Top Cherry Pie (8 inch size)
d) Lattice Top Peach Pie (8 inch size)
e) Lattice Top Pineapple Pie (8 inch size)
f) Pecan Pie (8 inch and 10 inch sizes)
g) Lemon Pie (8 inch size)
h) Strawberry Rhubarb Pie (8 inch size)
I) No Sugar Added Apple Pie (six inch size)
j) No Sugar Added Pumpkin Pie
k) No Sugar Added Strawberry Rhubarb Pie.
Recall #F-259/269-8.
CODE All product distributed prior to
January 12, 1998.
MANUFACTURER DeMoulas Supermarket Inc., Market Basket
Supermarket, Tewksbury, Massachusetts.
RECALLED BY Manufacturer, by telephone on January 12,
1998, and by press release on January 16,
1998. Firm-initiated recall (correction)
complete.
DISTRIBUTION Massachusetts and New Hampshire.
QUANTITY Undetermined.
REASON The products contain undeclared eggs.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
=============
_______________
PRODUCT Entuss-D Jr (Hydrocodone Bitartrate 2.5
mg/Pseudoephedrine Hydrochloride 30 mg),
Pediatric Expectorant Antitussive and Nasal
Decongestant, Rx, in 4 fluid ounce bottles.
NDC #59441-439-04. Recall #D-078-8.
CODE Lot #J960855A EXP 10/98.
MANUFACTURER Mikart, Inc., Atlanta, Georgia (contract
manufacturer).
RECALLED BY Roberts Pharmaceutical Corporation, Eatontown,
New Jersey (responsible firm), by press
release on January 30, 1998, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Eastern United States.
QUANTITY 538 bottles were distributed.
REASON Misbranding - Incorrect label dosage
instructions for adults which may lead to an
overdose situation.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============
_______________
PRODUCT Levothroid Tablets (Levothyroxine Sodium
Tablets, USP), 75 mcg, in 100 count bottles,
Rx, for replacement or substitution therapy
for diminished or absent thyroid function.
NDC #0456-0322-01. Recall #D-066-8.
CODE Lot #99618.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati,
Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., subsidiary of
Forest Laboratories, Inc., St. Louis,
Missouri, by letter dated January 16, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,382 bottles were distributed.
REASON Low tablet weights (subpotent).
_______________
PRODUCT Oxygen, USP, compressed medical gas packed in
size D, E, and M6 high pressure cylinders.
Recall #D-067-8.
CODE Lot numbers 018015 and 018019.
MANUFACTURER Richards Medical, Inc., New Philadelphia,
Ohio.
RECALLED BY Manufacturer, by telephone on January 20,
1998. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 7 cylinders were distributed.
REASON Good manufacturing practice deviation -
Failure to assay for strength prior to
distribution.
_______________
PRODUCT Lorcet 10/650 tablets (Hydrocodone Bitartrate
10 mg/Acetaminophen 650 mg), in 500 tablet
bottles, Rx, for the relief of severe pain.
Recall #D-070-8.
CODE Lot #F970490A.
MANUFACTURER Mikart, Inc., Atlanta, Georgia.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis,
Missouri (private label distributor), by
letter on November 25, 1997. Firm-initiated
recall complete.
DISTRIBUTION Missouri, Florida, Ohio.
QUANTITY 1,976 bottles were distributed, firm estimated
that 317 bottles remained on market at time of
recall initiation.
REASON Metal fragment found in one tablet.
_______________
PRODUCT Cedax (ceftibuten for oral suspension), 120 ml
(when reconstituted) 90 mg/5 ml).
NDC #0085-0777-02. Recall #D-075-8.
CODE Lot #7710411 EXP 8/99.
MANUFACTURER Schering Corporation, Miami Lakes, Florida.
Recalled by Schering Laboratories, Schering Plough
Corporation, Kenilworth, New Jersey, by letter
dated January 14, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,252 bottles were distributed.
REASON Subpotency due to low fill.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Caffeine and Sodium Benzoate Injection, USP,
0.5 g/2 ml, Rx sterile solution for
intramuscular or slow intravenous
administration to treat respiratory depression
associated with overdosage with CNS depressant
drugs. NDC #11098-505-02. Recall #D-057-8.
CODE Lot #101406.
MANUFACTURER Taylor Pharmaceuticals, Decatur, Illinois.
RECALLED BY Manufacturer, by letter dated November 25,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 366 cartons were distributed; firm estimated
that 33 percent of product remained on market
at time of recall initiation.
REASON Mislabeling - The ampule label and shelf
carton fail to list the strength of the
caffeine and sodium benzoate. Also, the shelf
carton lists the ampule size as 2 ml on the
principle display panel and 1 ml the end flap.
_______________
PRODUCT Hydroxyzine Hydrochloride Syrup, USP, in 16
ounce and 1 gallon containers, for symptomatic
relief of anxiety and tension, under the
Alpharma, Schein, Barre, and Rugby labels.
Recall #D-068-8.
CODE Lot numbers: RA6017, RA6018, RF6315, RJ6429,
RL6634, RP6815, RS6895, RC7179, RD7245,
RD7246, RH7425, RK7583, RL7683.
MANUFACTURER Alpharma, U.S. Pharmaceuticals Division,
Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated January 15,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 132,206 units remained in
commerce at time of recall initiation.
REASON Subpotent.
_______________
PRODUCT Microcrystalline Cellulose, NF (Avicel), in 50
kg drums, boxes and/or bags, a critical
excipient and influences the flow of the
active ingredient and excipeints during
tableting and encapsulation. It also aids in
compaction during compression.
Recall #D-069-8.
CODE Lot #1711.
MANUFACTURER FMC Corporation, Newark, Delaware.
RECALLED BY Manufacturer, verbally, and by fax on or about
April 28, 1997. Firm-initiated recall
complete.
DISTRIBUTION Colorado, Puerto Rico, Texas.
QUANTITY 92 drums were distributed; firm estimates none
remains on market.
REASON Product failed pH and conductivity testing.
_______________
PRODUCT a) Acetylcysteine Solution, USP 20% (200
mg/ml) 30 ml vials, packaged in units of 3,
Rx, Mucolytic; for bronchial indications such
as asthma and tuberculosis. NDC #0517-7630-03
b) Concentrated Sodium Chloride Injection,
USP, 23.4% (234 mg/ml) in 30 ml single dose
vials, Rx, additive in parenteral fluid
therapy for use in patients who have problems
with Sodium electrolytic intake or excretion.
NDC #0517-2930-23. Recall #D-071/072-8.
CODE Lot numbers: a) 7855 EXP 5/99; b) 7846 EXP
11/99.
MANUFACTURER American Regent Laboratories, Inc., Shirley,
New York.
RECALLED BY Manufacturer, by fax on January 6, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 44,097 vials; b) 163,375 vials were
distributed; firm estimated that a) 75-80
percent; b) 80 percent of the product remained
on market at time of recall initiation.
REASON Mispackaging - Correctly labeled concentrated
sodium chloride injection vials placed into
intermediate cartons labeled as Acetylcysteine
Solution.
_______________
PRODUCT Scopolamine Hydrobromide Injection, USP, 0.4
mg/ml in 1 ml multiple dose vials.
Recall #D-073-8.
CODE Lot #360116 EXP 2/28/99.
MANUFACTURER Fujisawa USA, Inc., Grand Island, New York.
RECALLED BY Fujisawa USA, Inc., Deerfield, Illinois, by
letter issued dated January 26, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 137,650 vials were distributed.
REASON Subpotent (stability).
_______________
PRODUCT EC-Naprosyn (Naproxen) Enteric Coated,
Delayed-Release Tablets, 375 mg, unit dose
pouches, 10 pouches/carton, Professional
Samples, Rx non-steroidal anti-inflammatory
drug (NSAID) with analgesic and anti-pyretic
properties. NDC #13-41-03255-0396.
Recall #D-074-8.
CODE Lot #B1398 EXP 1/99.
MANUFACTURER Syntex Puerto Rico, Humacao, Puerto Rico.
RECALLED BY Roche Laboratories, Nutley, New Jersey
(responsible firm), by telephone on May 29,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 120,000 cartons were distributed.
REASON Mislabeling - Carton label incorrectly
declares contents as 500 mg not 375 mg.
_______________
PRODUCT Epinephrine Injection, USP 1:1000 (1mg/ml), 1
mL ampule, sterile, Rx, intramuscular or
subcutaneous liquid injection, preservative
free. Packaged in boxes of 25 x 1 mL ampules.
A sympathetic, vaso-constricting, ommetic drug
commonly used to relieve respiratory distress
due to bronchospasm, to provide rapid relief
of hypersensitivity reactions to drugs and
other allergens, and to prolong action of
infiltration anesthetics. May restore cardiac
rhythm. NDC# 0517-1071-25. Recall #D-076-8.
CODE Lot Numbers: 6487 EXP 1/98, 6654 EXP 2/98,
6862 EXP 5/98, 7278 EXP 10/98, 7414 EXP 11/98,
7415 EXP 11/98, 7424 EXP 11/98, 7471 EXP
12/98, 7659 EXP 2/99, 7728 EXP 3/99, 7783 EXP
4/99, 6738 EXP 3/98, 6972 EXP 6/98, 7040 EXP
7/98 7126 EXP 8/98.
MANUFACTURER American Regent Laboratories, Inc., Shirley,
New York.
RECALLED BY Manufacturer, by letter on January 23, 1998,
followed by telephone. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 715,575 ampules were distributed.
REASON Discoloration - Product fails color and
clarity specifications.
_______________
PRODUCT ARTH-Rx (Methyl Nicotinate 0.5% Capsaicin
0.025%) Topical Analgesic Lotion, in 3 ounce
units, for the temporary relief of minor aches
and pains of muscles and joints.
Recall #D-077-8.
CODE All lots on the market.
MANUFACTURER Phillips Pharmatech Labs, Inc., Largo, Florida
(responsible firm).
RECALLED BY Phillips Gulf Corporation, Largo, Florida, by
letter dated December 12, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION North Carolina, Florida, Georgia, Texas,
Pennsylvania, New York, Illinois, California.
QUANTITY 12,456 bottles were distributed.
REASON Product fails to bear an expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT Source Plasma. Recall #B-062-8.
CODE Unit #KP45234.
MANUFACTURER Plasma Biological Services, Inc., Memphis,
Tennessee.
RECALLED BY Manufacturer, by telephone on August 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the hepatitis C virus encoded
antigen (anti-HCV).
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-558/559-8.
CODE Unit #17180-8438.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated October 7, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported previously testing positive for
Hepatitis C.
_______________
PRODUCT a) Whole Blood
b) Red Blood Cells
c) Platelets
d) Cryoprecipitated AHF
e) Plasma
f) Recovered Plasma. Recall #B-562/567-8.
CODE Unit numbers: a) 042G33422, 042G95948
b) 042M10357, 42Q55415, 42K80462, 42Y51968,
42Q44818
c) 42Q55415; d) 42K80462; e) 42Q44818
f) 042M10357, 42Q55415, 42K80462, 42Y51968.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters dated December 31,
1996, June 10, 1997, and January 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio, California, New York.
QUANTITY a) 2 units; b)5 units; c) 1 unit; d) 1 unit;
e) 1 unit; f) 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
donors who previously tested repeatedly
reactive for anti-HIV-1, unlicensed Western
blot negative.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-569/570-8.
CODE Unit #12FZ30058.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on March 1, 1996,
followed by letter dated March 4, 1996, and by
fax on March 4, 1996. Firm-initiated recall
complete.
DISTRIBUTION North Carolina and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-572/573-8.
CODE Unit #12LS24601.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letters dated November 24 and
25, 1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT Red Blood Cells. Recall #B-574-8.
CODE Unit #12G14466.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on November 30,
1997, followed by letter dated December 5,
1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at room temperature
for greater than 30 minutes.
_______________
PRODUCT Red Blood Cells. Recall #B-575-8.
CODE Unit #03GS25269.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated November 26,
1997. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-578/579-8.
CODE Unit #7827927.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated December 18,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-580/581-8.
CODE Unit numbers: a) 29444-4047, 29446-4195
b) 29446-4195.
MANUFACTURER United Blood Services, Chicago, Illinois
RECALLED BY Manufacturer, by letters dated December 16,
1997, and February 2, 1998. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
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 Red Blood Cells. Recall #B-585-8.
CODE Unit #V46600.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letter dated December 10,
1997. Firm-initiated recall completed.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product, which tested negative for
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but collected from a
donor who previously tested repeat reactive
for anti-HIV-1, Western Blot negative and was
incorrectly reentered.
_______________
PRODUCT Red Blood Cells. Recall #B-586-8.
CODE Unit #V45569.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letter dated December 10,
1997. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for antibody to
the human immunodeficiency virus type 1
(anti-HIV-1), but collected from a donor who
previously tested repeat reactive for
anti-HIV-1, Western Blot negative and was
incorrectly reentered.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Platelets, Pheresis. Recall #B-571-8.
CODE Unit #12FL02334.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on May 16, 1996,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
health history screening was incomplete.
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-576-8.
CODE Unit #03GM39865.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on December 12,
1997, followed by letter dated December 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood with an extended collection time.
_______________
PRODUCT Red Blood Cells. Recall #B-577-8.
CODE Unit #03KE07823.
MANUFACTURER American Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on October 17,
1997, and by letter dated October 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
provided incomplete medical history.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II ==========
_______________
PRODUCT Isolate Sperm Separation Media, intended for
use as a human sperm separation medium for
intra-uterine insemination (IUI):
a) Catalog #99257
b) Catalog #99258
c) Catalog #99264 (2x50 mL)
#99264 (12x16 mL)
d) Catalog #99275 Lot #9927570906.
Recall #Z-314/317-8.
CODE a) Lot #9925770911; b) Lot #9925870911
c) Lot #9926471016 (2x50 mL);
Lot #9926471017 (12x16 mL)
d) Lot #9927570906.
MANUFACTURER Irvine Scientific, Santa Ana, California.
RECALLED BY Manufacturer, by telephone and letter on
December 22, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Arizona, California, Connecticut, Illinois,
Indiana, Michigan, Nebraska, New York,
Pennsylvania, Rhode Island, Texas, Washington
state.
QUANTITY a) 40 bottles; b) 93 boxes; c) 27 boxes;
d) 39 bottles were distributed.
REASON Products were found to be contaminated with
fungus.
_______________
PRODUCT a) Renasol Liquid Bicarbonate Concentrate
BC-1-L Part B in one gallon (3.78 liter)
bottles;
b) Naturalyte 9000 Liquid Bicarbonate
Concentrate in one gallon (3.78 liter)
bottles, product catalog number 08-9990-6, a
bicarbonate dialysis concentrate, which is
mixed with an acid concentrate and water to
produce dialysate for hemodialysis.
Recall #Z-318/319-8.
CODE a) Part B: Lot 03J702, MFD 09 97, EXP 03 99
b) Lot 67K707, MFD 10 97, EXP 04 99.
MANUFACTURER Minntech Corporation, Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone on January 16,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,416 cases (4 gallons per case) were
distributed.
REASON Concentrate contains mold.
_______________
PRODUCT Implants for Retinal Detachment Surgery:
a) Circling Band 240-Style 2.5 5/Box, Catalog
No. E5381 700; b) Non Sterile Band, Catalog
No. NSE5381-700, c) Silicone Strip 219-Style
Grv 4.5 5/Box, Catalog No. E5381 710,
d) Non Sterile Silicone Strip, Catalog No.
NSE5381-710. Recall #Z-320/323-8.
CODE Lot numbers: a) MH72550; b) 97246; MH73580;
d) 97246.
MANUFACTURER Vesta, Inc., Franklin, Wisconsin.
RECALLED BY Storz Instrument Company, St. Louis, Missouri,
by letter dated January 6, 1998, and by fax on
January 7 and 13, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY a) 2,085 implants; b) 200 implants; c) 235
implants; d) 5 implants were distributed.
REASON The products do not meet the firms
requirements for elongation and may exhibit
cracks or may break when stretched.
_______________
PRODUCT Maxima Forte Oxygenator: a) Model MAX-FTC;
b) Model MAX-FTE. Recall #Z-329/330-8.
CODE All lots.
MANUFACTURER Medtronic, Inc., Anaheim, California.
RECALLED BY Manufacturer, by letter July 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 9,600 units were distributed.
REASON There is a possibility that the devices heat
exchanger may leak, which may cause blood loss
during transfusion.
_______________
PRODUCT Bear Cub Infant Pressure Infant Ventilator,
Model 750vs. Recall #Z-333-8.
CODE All serial numbers.
MANUFACTURER Dale Electronics, Tempe, Arizona (component
supplier).
RECALLED BY Allied Healthcare Products, Inc., Ventilation
Products Division, Riverside, California, by
fax beginning on March 10, 1997, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 338 units were distributed.
REASON The potentiometer may become unstable making
setting the controls difficult or impossible.
_______________
UPDATE Recall Z-039/040-8, Horizon/Horizon Nxt
Modular Infusion Pumps which appeared in the
November 19, 1997 Enforcement Report is being
rescinded. Completion of B. Braun McGaw's
investigation determined that the devices were
not defective, but that the test method used
was causing the erroneous results. On
November 16.1997 the firm notified all users
that the pumps performed within spec. The
recall numbers will be reassigned.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
============
_______________
PRODUCT Sheep Starter/Grower BT Pellets Medicated, in
50 pound bags, for prevention of coccidiosis
in sheep. Recall #V-006-8.
CODE Lot #SP27063.
MANUFACTURER MFA, Inc., Springfield, Missouri.
RECALLED BY MFA, Inc., Columbia, Missouri, on or about
December 20, 1997. Firm-initiated recall
complete.
DISTRIBUTION Missouri.
QUANTITY 88 bags were distributed.
REASON Product was superpotent in lasalocid due to
sequencing after a high lasalocid-containing
feed.
END OF ENFORCEMENT REPORT FOR FEBRUARY 18, 1998. BLANK PAGES
MAY FOLLOW.
End of Enforcement Report for
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