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.
ENFORCE
12/11/1990
FDA Enforcement for the week of December 12, 1990
FDA ENFORCEMENT REPORT
FOR DECEMBER 12, 1990
December 12, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
-1-
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Recovered Plasma. Recall #B-049-1.
Code: Unit #KD9223.
Manufacturer: King's Daughter Hospital Blood Bank, Temple, Texas.
Recalled by: Manufacturer, by letter September 27, 1990.
Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 1 unit.
Reason: Recovered Plasma, which tested initially reactive for
hepatitis B surface antigen (HBsAg), was distributed.
----
Class III -
Product: Recovered Plasma. Recall #B-050-1.
Code: Unit #KD9230.
Manufacturer: King's Daughter Hospital Blood Bank, Temple, Texas.
Recalled by: Manufacturer, by letter September 27, 1990.
Firm-initiated recall complete.
Distribution: Florida.
Quantity: 1 unit.
Reason: Recovered Plasma, which tested initially reactive for
hepatitis B surface antigen (HBsAg), was distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Software Release 2.75 and 2.75a used with Modulex brand
Radiation Treatment Planning (RTP) System Models 1000,
2000 and 3000.
Recall #Z-073/074-1.
Code: Software disk packs and cartridges are not individually
coded. They are identified as Release 2.75.
Manufacturer: Computerized Medical Systems, Inc. (CMS), Maryland
Heights, Missouri.
Recalled by: Manufacturer, by telephone followed by letters of April 18,
1990 and October 22, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Germany, Spain, Japan, Hong Kong, Peru, Uruguay.
Quantity: Unknown.
Reason: Errors may can result in patients receiving significant
overdosage or underdosage of radiation.
----
-2-
Class II -
Product: Softip Diagnostic Cardiology Catheters:
(a) Schneider 7 French High Flow Pigtail Catheter,
125 degree, 145 degree and 155 degree Pigtail;
(b) 7 French High Flow Straight Pigtail;
(c) Three-Catheter Kits with Dilator and without Dilator
containing 7 French High Flow Pigtail Catheters;
(d) Brachial (Sones Techniques) 8 French High Torque
Catheter. Recall #Z-039/042-1.
Code: Model No. Lot No.
K17-102 FKW003301, KUB900801, KUB901101, KUB902701,
KUB902801
K17-103 KUC900901, KUC901301, KUC903001
K17-104 FKW003300, KUD900601, KUD900801, KUD900901,
KUD901002, KUD901101, KUD901401
K17-132 KUL900401, KUL900501
K17-133 KUK900401,
K18-024 FZG884801, FZG885201, FZG900801, FZG902901,
300717, 302526
K18-025 FZH884901, FZH885201, FZH885202, FZH890201
FZH890701, FZH891101, FZH900801, 104142
302118
K37-104 MDN902801, MDN902802
SWO-1087-1 FKW001954
SWO-1087-2 FKW001955
SWO-1087-3 FKW001956
SWO-1087-4 FKW001957
SWO-1087-5 FKW001958
SWO-1087-6 FKW001959
SWO-1500-1 VNA902502
SWO-1500-2 VNA902403
SWO-1500-3 VNA902404
SWO-1503 VNA902405.
Manufacturer: Schneider (USA), Inc., Plymouth, Minnesota.
Recalled by: Manufacturer, by telephone September 14, 1990 followed by
letter September 17, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Japan, Australia, The Netherlands, Canada,
Argentina.
Quantity: 8,250 units were distributed.
Reason: The distal plastic stem which is 3-4" in length may crack
when straightened.
----
Product: Bovie Model CSV Electrosurgical Units. Recall #Z-098-1.
Code: All serial numbers manufactured since January 1989 until
August 1990.
-3-
Manufacturer: MDT Diagnostic Company, North Charleston, South Carolina.
Recalled by: Manufacturer, by letter September 14, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Turkey, Hong Kong, Canada, Japan, Korea, Ireland,
Taiwan, Thailand, Portugal, Poland.
Quantity: 229 units were distributed.
Reason: The circuit sentry module/feature may fail to provide an
alarm in the event of an interruption of the return path
circuitry from the patient dispersive pad to the
electrosurgical unit.
----
Product: Trach Suction Kit, Model No. 11140, a breathing system
suction kit used in a hospital setting for emergency use
to clear mucus and other obstructions of the trachea of
patients in respiratory distress. Recall #Z-106-1.
Code: General Medical Item #190057 (85-9150).
Manufacturer: Assembled Products Center, General Medical Manufacturing
Corporation, Des Moines, Iowa.
Recalled by: General Medical Manufacturing Corporation, Richmond,
Virginia, by telephone May 14, 1990. Firm-initiated
recall ongoing.
Distribution: Kentucky, California, Texas, Iowa, Wisconsin, Illinois.
Quantity: 600 kits were distributed; firm estimates none remains
on market.
Reason: Flattening of the tube which could result in reduced
suction or no suction.
----
Product: Saxon Wet Lubricated Condoms, in plastic film and packed
in boxes of 3. Boxes of 3 packed in boxes of 1/2 gross.
Recall #Z-111-1.
Code: Lot 12I05.
Manufacturer: Safetex Corporation, Colonial Heights, Virginia.
Recalled by: Manufacturer, by telephone and letter November 9, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 200 gross were distributed.
Reason: Condoms failed FDA leak test.
----
Class III -
VETERINARY PRODUCTS
Class I -
NONE
-4-
Class II -
Product: 48 parenteral veterinary products:
A. AMP-200, 50-ml vials, Rx, for intramuscular administration, aids in the
restoration of proper muscle function and helps relieve pain, swelling and
tenderness associated with myostitis, bursitis, and tendonitis. The product is
marketed under the following names and labels:
(1) AMP-200 - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) AMP-200 - CHAMPION PHARMACEUTICAL PRODUCTS, INC.,
PHOENIX, AZ
(3) AD-200 - A & G PHARMACEUTICALS, CLARKSBURG, NJ
(4) ADENOSINE-200 - VICTOR MEDICAL CO., IRVINE, CA
B. Ammonium Sulfate Injection, 0.75%/ml, 30-ml vials, Rx, administration by
local infiltration or nerve block, for use as a local analgesic. The product
is marketed under the following names and labels:
(1) AMMONIUM SULFATE INJECTION, A&G PHARMACEUTICALS, CLARKBURG, NJ
(2) AMBLOC INJECTION, CHAMPION PHARMACEUTICAL PRODUCTS, INC.,
PHOENIX, AZ
C. Calcium Gluconate 23%, 500-ml vials, OTC, intramuscular or subcutaneous
administration, for use as an aid in the treatment of hypocalcemia (parturient
paresis, milk fever) in cattle. The product is marketed under the following
names and labels:
(1) CALCIUM GLUCONATE 23% - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) CALCIUM GLUCONATE 23% - PREMIER FARMTECH, KANSAS CITY, MO
(3) CALCIUM GLUCONATE 23% SOLUTION - RX VETERINARY PRODUCTS,
PORTERVILLE, CA
(4) CALCIUM GLUCONATE 23% - HENRY SCHEIN, INC., PORT WASHINGTON, NY
(5) CALCIUM GLUCONATE 23% SOLUTION - DURVET, INC., BLUE SPRINGS, MO
(6) CALCIUM GLUCONATE 23% SOLUTION - AGRI LABORATORIES, LTD., ST.
JOSEPH, MO
(7) CALCIUM GLUCONATE 23% - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH,
MO
(8) CALCIUM GLUCONATE 23% SOLUTION - UNIVERSAL COOPERATIVES, INC.,
MINNEAPOLIS, MN
(9) HI-CAL 23% - IBA INC., MILLBURY, MA
(10) CAL-GLUCO - UCKELE ANIMAL HEALTH CORPORATION, BLISSFIELD, MI
(11) CAL-NATE 1069 - THE BUTLER COMPANY, COLUMBUS, OH
D. CAL Glycerol Injectable, 250-ml vials, Rx, intravenous administration, for
use in cattle, sheep, and swine that are exhibiting deficiencies or imbalance
of calcium (such as milk fever). The product is marketed under Champion
Pharmaceutical Products, Inc., Phoenix, AZ.
E. Calphite Injection, 500-ml vials, Rx and OTC, intravenous administration,
for use as an aid in the treatment of hypocalcemia (parturient paresis, milk
fever), hypomagnesemia (grass tetany), and other conditions associated with
calcium, phosphorus and magnesium deficiencies in cattle, sheep, swine and
horses. The product is marketed under the following names and labels:
(1) CALPHITE INJECTION - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) CALPHITE REINFORCED INJECTION - VETERINARY LABORATORIES, INC.
(3) CMP WITH DEXTROSE - L AND M PHARMACEUTICALS, DALLAS, TX
(4) CMP PLUS - L AND M PHARMACEUTICALS, DALLAS, TX
(5) CAL-PHOS #2 - VEDCO, INC., ST. JOSEPH, MO
(6) CAL-PHOS #2 INJECTION - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
-5-
(7) CAL PHOS #2 WITH POTASSIUM INJECTION - PHOENIX PHARMACEUTICAL,
INC.,
ST. JOSEPH, MO
(8) CAL-PHOS IMPROVED - AGRI LABORATORIES, LTD., ST. JOSEPH, MO
(9) CAL-DEX-MPK - UNIVERSAL COOPERATIVES, INC., MINNEAPOLIS, MN
(10) CAL-DEX-PLUS - RX VETERINARY PRODUCTS, PORTERVILLE, CA
(11) CAL-DEX-PLUS - VETERINARY LABORATORIES, INC.
(12) CALDEX SOLUTION - VEDCO, INC., ST. JOSEPH, MO
(13) CAL-D-MAG-PK - UCKELE ANIMAL HEALTH CORPORATION, BLISSFIELD, MI
(14) C-M-P-K - L AND M PHARMACEUTICALS, DALLAS, TX
(15) C-M-P-K INJECTION - L AND M PHARMACEUTICALS, DALLAS, TX
(16) C-M-P-K INJECTION - DURVET, INC., BLUE SPRINGS, MO
(17) C-M-P-K INJECTION - PRO LAB LTD., ST. JOSEPH, MO
(18) C-M-P-K INJECTION - VETERINARY LABORATORIES, INC.
(19) CMPK SOLUTION - VEDCO, INC., ST. JOSEPH, MO
(20) CMPK - RX VETERINARY PRODUCTS, PORTERVILLE, CA
(21) CMPK - AGRI LABORATORIES, ST. JOSEPH, MO
(22) CAL-MPK 1234 - THE BUTLER COMPANY, COLUMBUS, OH
(23) CALCIPHOS - RX VETERINARY PRODUCTS, PORTERVILLE, CA
F. Carbochol, in 30-ml vials, Rx, subcutaneous administration, for the
treatment of colic and impactions of the intestinal tract in horses, and Rumen
Atony and impaction in cattle. The product is marketed under the following
names and labels:
(1) CARBOCHOL - THE BUTLER COMPANY, COLUMBUS, OH
(2) PERISTAL SOLUTION - VET LABS LIMITED, INC., LENEXA, KS
G. Lactated Ringer's in 5% Dextrose, 1000-ml vials, Rx, intravenous
administration, for replacement of acute fluid and electrolyte losses and for
correction of mild acidosis. The product is marketed under the following
names and labels:
(1) LACTATED RINGERS IN 5% DEXTROSE - VEDCO, INC., ST. JOSEPH, MO
(2) DEXTROSE 5% IN LACTATED RINGER'S - VIRBAC, INC., LENEXA, KS
H. Lactated Ringer's Solution, 1000-ml vials, Rx, intravenous or subcutaneous
administration, for use in conditions associated with fluid and electrolyte
loss where a balanced, isotonic replacement solution is indicated, such as
dehydration, shock, vomiting and diarrhea in cattle, horses, sheep, swine,
dogs and cats. The product is marketed under the following names and labels:
(1) LACTATED RINGER'S SOLUTION - VETERINARY LABORATORIES, INC., LENEXA,
KS
(2) LACTATED RINGER'S SOLUTION - DURVET, INC., BLUE SPRINGS, MO
(3) LACTATED RINGER'S SOLUTION - EQUINE PRODUCTS OF AMERICA, INC.,
FT. COLLINS, CO
(4) LACTATED RINGER'S SOLUTION - RX VETERINARY PRODUCTS, PORTERVILLE,
CA
(5) LACTATED RINGER'S SOLUTION - L AND M PHARMACEUTICALS, DALLAS, TX
(6) LACTATED RINGER'S SOLUTION - A & G PHARMACEUTICALS, CLARKSBURG, NJ
(7) LACTATED RINGER'S SOLUTION - CHAMPION PHARMACEUTICAL PRODUCTS,
INC.,
PHOENIX, AZ
(8) LACTATED RINGER'S INJECTION - VEDCO, INC., ST. JOSEPH, MO
(9) LACTATED RINGER'S INJECTION - VIRBAC, INC., LENEXA, KS
(10) LACTATED RINGERS INJECTION - THE BUTLER COMPANY, COLUMBUS, OH
I. Lactated Ringer's Concentrate, 250-ml vials, Rx, intravenous or
subcutaneous administration, for electrolyte replacement therapy. The product
is marketed under Ceva Laboratories, Inc., Overland Park, KS, label.
-6-
J. Dextrose 50% Injection, 500-ml vials, Rx and OTC, intravenous
administration, for use as a fluid and nutrient replenisher; provides an
immediate source of energy in conditions associated with carbohydrate
insufficiency; and useful for rapid but temporary symptomatic treatment of
ketosis (acetonemia) in cattle and other hypoglycemic conditions in cattle,
horses, sheep, swine, dogs and cats. The product is marketed under the
following names and labels:
(1) DEXTROSE 50% INJECTION - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) DEXTROSE 50% INJECTION - VICTOR MEDICAL CO., IRVINE, CA
(3) DEXTROSE 50% INJECTION - PREMIER FARMTECH, KANSAS CITY, MO
(4) DEXTROSE SOLUTION 50% - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH,
MO
(5) DEXTROSE SOLUTION 50% - L AND M PHARMACEUTICALS, DALLAS, TX
(6) DEXTROSE SOLUTION 50% - THE BUTLER COMPANY, COLUMBUS, OH
(7) DEXTROSE SOLUTION 50% - UNIVERSAL COOPERATIVES, INC., MINNEAPOLIS,
MN
(8) DEXTROSE SOLUTION 50% - UCKELE ANIMAL HEALTH CORP., BLISSFIELD, MI
(9) DEXTROSE 50% SOLUTION - VEDCO, INC., ST. JOSEPH, MO
(10) DEXTROSE 50% - RX VETERINARY PRODUCTS, PORTERVILLE, CA
(11) DEXTROSE 50% - J. A. WEBSTER, INC., STERLING, MA
(12) DEXTROSE 50% - IBA, INC., MILLBURY, MA
(13) DEXTROSE 50% - AGRI LABORATORIES, LTD., ST. JOSEPH, MO
(14) DEXTROSE 50% - DURVET, INC., BLUE SPRINGS, MO
K. Dextrose-F Sterile Solution, 500-ml vials, OTC, intravenous administration,
for use as an aid in the treatment of uncomplicated primary ketosis in cattle.
The product is marketed under Agri Laboratories, Ltd., St. Joseph, MO.
L. Dexolyte Solution, 500-ml and 1000-ml vials, Rx, intravenous or
intraperitoneal administration, for use in conditions associated with fluid
and electrolyte loss, such as dehydration, shock, vomiting and diarrhea,
particularly when an immediate source of energy is also indicated. The
product is marketed under the following names and labels:
(1) DEXOLYTE SOLUTION - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) DEXOLYTE SOLUTION - VET LABS LIMITED, INC., LENEXA, KS
(3) DEXOLYTE SOLUTION - A & G PHARMACEUTICALS, CLARKSBURG, NJ
(4) ELECTRO-JECT - UCKELE ANIMAL HEALTH CORPORATION, BLISSFIELD, MI
(5) ELECTROLYTE INJECTABLE WITH DEXTROSE - DURVET, INC., BLUE SPRING,
MO
(6) ELECTROLYTE SOLUTION WITH DEXTROSE - PHOENIX PHARMACEUTICALS,
ST. JOSEPH,
MO
(7) ELECTROLYTE SOLUTION WITH DEXTROSE - PRO LABS LTD., ST. JOSEPH, MO
(8) ELECTROLYTE SOLUTION WITH DEXTROSE - LEXTRON, INC., GREELEY, CO
(9) ELECTROLYTE SOLUTION WITH DEXTROSE - VEDCO, INC., ST. JOSEPH, MO
(10) ELECTROSOL SOLUTION - L AND M PHARMACEUTICALS, DALLAS, TX
(11) EQUI-LYTE SOLUTION - WESTERN MEDICAL SUPPLY INC., ARCADIA, CA
(12) EQUI-LYTE SOLUTION - EQUINE PRODUCTS OF AMERICA, INC., FT. COLLINS,
CO
(13) EQUILYTES-PLUS - VICTOR MEDICAL CO., IRVINE, CA
(14) POLYLITES II - THE BUTLER COMPANY, COLUMBUS, OH
(15) THERALYTE SOLUTION - CHAMPION PHARMACEUTICAL PRODUCTS, INC.,
PHOENIX, AZ
(16) SHIPPED UNLABELED TO STERIVET LABORATORIES, MISSISSAUGA,
ONTARIO, CANADA
M. Dextrose 5% in Water, 1000-ml vials, Rx, intravenous or subcutaneous
administration, for correction of fluid deficits and to re-establish and
improve renal function. The product is marketed under Virbac, Inc., Ft.
Worth, Tx, label.
-7-
N. Dextrose 2 1/2% in Saline 0.45%, 1000-ml vials, Rx, intravenous or
subcutaneous administration, for dehydration and to re-establish and improve
renal function. The product is marketed under Virbac, Inc., Ft. Worth, TX,
label.
O. Dextrose 2 1/2% in 1/2 strength Lactated Ringer's, 1000-ml vials, Rx,
intravenous or subcutaneous administration, for replacement of acute fluid and
electrolyte losses and for correcting mild acidosis. The product is marketed
under Virbac, Inc., Ft. Worth, TX, label.
P. Multilyte-R, 1000-ml vials, Rx, intravenous or subcutaneous administration,
for replacing acute losses of extracellular fluid and electrolytes and for
correcting moderate to severe acidosis. The product is marketed under
Virbac, Inc., Lenexa, KS, label.
Q. Solute-R 5L, 250-ml vials, Rx, intravenous or subcutaneous administration,
for replacing acute losses of extracellular fluid and electrolytes and for
correcting moderate to severe acidosis. The product is marketed under Virbac,
Inc., Lenexa, KS., label.
R. Glucolyte, 1000-ml vials, Rx, intravenous administration, for use in the
treatment of ketosis (acetonemia) and other hypoglycemic conditions in dairy
cattle and as an aid in conditions associated with electrolyte depletion. The
product is marketed under Vedco, Inc., St. Joseph, MO, label.
S. Multisol-R 3X, 100-ml vials, Rx, intravenous or subcutaneous
administration, for replacement electrolyte therapy. The product is marketed
under Ceva Laboratories, Inc., Overland Park, KS, label.
T. Dipyrone Injection 50%, 100-ml and 250-ml vials, Rx, intravenous,
intramuscular, or subcutaneous administration, for use as an antipyretic agent
in the management of intractable fever where other forms of therapy have been
ineffective. The product is marketed under the following names and labels:
(1) DIPYRONE INJECTION 50% - VETERINARY LABORATORIES, INC.,
LENEXA, KS
(2) DIPYRONE INJECTION 50% - EQUINE PRODUCTS OF AMERICA, INC., FT.
COLLINS, CO
(3) DIPYRONE INJECTION 50% - PRO LABS LTD., ST. JOSEPH, MO
(4) DIPYRONE INJECTION 50% - LEXTRON, INC., GREELEY, CO
(5) DIPYRONE INJECTION 50% - L AND M PHARMACEUTICALS, DALLAS, TX
(6) DIPYRONE INJECTION 50% - HENRY SCHEIN, INC., PORT WASHINGTON, NY
(7) DIPYRONE 50% INJECTION - VEDCO, INC., ST. JOSEPH, MO
(8) DIPYRONE 50% INJECTION - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH,
MO
(9) DIPYRONE 50% INJECTION - RX VETERINARY PRODUCTS, PORTERVILLE, CA
(10) DIPYRONE 500 MG INJECTION - VICTOR MEDICAL CO., IRVINE, CA
(11) DIPYRONE INJECTABLE - THE BUTLER COMPANY, COLUMBUS, OH
U. Gecolate, 1000-ml vial, Rx, intravenous administration, for use as a
skeletal muscle relaxant for horses. The product is marketed under Summit Hill
Laboratories, Navesink, NJ, label.
V. Iron hydrogenated Dextran Injection, 100-ml vials, OTC, intramuscular
administration, for the prevention and treatment of anemia due to iron
deficiency in baby pigs. The product is marketed under the following names
and labels:
-8-
(1) IRON HYDROGENATED DEXTRAN INJECTION - VETERINARY LABORTORIES,
INC., LENEXA,
KS.
(2) IRON HYDROGENATED DEXTRAN INJECTION - QUALITY PLUS ESSAR
CORPORATION, FT.
DODGE, IA
(3) IRON HYDROGENATED DEXTRAN INJECTION - PHOENIX PHARMACEUTICAL,
INC., ST.
JOSEPH, MO
(4) IRON HYDROGENATED DEXTRAN INJECTION - IBA, INC., MILLSBURY, MA
(5) IRON DEXTRAN - THE BUTLER COMPANY, COLUMBUS, OH
(6) IRON DEXTRAN - D.V.M SUPPLY, INC., SPENCER, IA
(7) IRON DEXTRAN COMPLEX INJECTION - RX VETERINARY PRODUCTS,
PORTERVILLE, CA
(8) IRON INJECTABLE - UNIVERSAL COOPERATIVES, INC., MINNEAPOLIS, MN
(9) IRON INJECTABLE - LAND O'LAKES, INC., FT. DODGE, IA
(10) INJECTABLE IRON - VEDCO, INC., ST. JOSEPH, MO
(11) INJECTABLE IRON - INTERNATIONAL MULTIFOODS, MINNEAPOLIS, MN
(12) INJECTABLE IRON DEXTRAN COMPLEX - KENT FEEDS, INC., MUSCATINE, IA
(13) DEXAN - CADCO, INC., DES MOINES, IA
(14) INJECT-A-IRON - SQUEALER FEEDS, HARLAN, IA
(15) FERRODEX 100 - AGRI LABORATORIES, LTD., ST. JOSEPH, MO
V. Injectable laxative, 100-ml vials, Rx, intramuscular or subcutaneous
administration, for the treatment of constipation, colic, intestinal
impactions, and Rumen Atony. The product is marketed under the following names
and labels:
(1) INJECTABLE LAXATIVE - VETERINARY LABORATORIES, INC.
(2) INJECTABLE LAXATIVE - UCKELE ANIMAL HEALTH DISTRIBUTING, INC.,
BLISSFIELD,
MI
(3) INJECTABLE LAXATIVE - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
(4) INJECTABLE LAXATIVE - LANGFORD, INC., GUELPH, ONTARIO, CANADA
(5) INJECTABLE LAXATIVE - VEDCO, INC., ST. JOSEPH, MO
(6) INJECTABLE LAXATIVE - RICHMOND VETERINARY SUPPLY, RICHMOND, VA
(7) LAXA-JEX - AMCO DRUG PRODUCTS CO., INC., NORTH OLMSTED, OH
(8) PERISTAL - VETERINARY LABORATORIES, INC.
W. Calcilyte K, 1000-ml vials, Rx, intravenous administration, for use as an
aid in treatment of hypocalcemic conditions in dairy cattle. The product is
marketed under Vedco, Inc., St. Joseph, MO, label.
X. Lactanase, 250-ml vials, Rx, intravenous administration, for use as a
mineral supplement for horses only. The product is marketed under Sterivet
Laboratories, Inc., Omaha, NE, label.
Y. Lidocaine Injectable, 100-ml vials, Rx, administration by infiltration,
nerve block, or epidural, for use as a potent local anesthetic for producing
epidural, nerve conduction and infiltration anesthesia. The product is
marketed under the following names and labels:
(1) LIDOCAINE INJECTABLE - VETERINARY LABORATORIES, INC.
(2) LIDOCAINE INJECTABLE - L AND M PHARMACEUTICALS, DALLAS, TEXAS
(3) LIDOCAINE 2% INJECTABLE - THE BUTLER COMPANY, COLUMBUS, OH
(4) LIDOCAINE INJECTABLE 2% - VEDCO, INC., ST. JOSEPH, MO
(5) LIDOCAINE INJECTABLE 2% - HENRY SCHEIN, INC., PORT WASHINGTON, NY
(6) LIDOCAINE HYDROCHLORIDE INJECTABLE 2% - PHOENIX PHARMACEUTICAL,
INC.,
ST. JOSEPH, MO
-9-
Z. Magnalyte, 1000-ml vials, Rx, intravenous administration, for use as an aid
in the treatment of hypomagnesemic conditions such as grass tetany associated
with magnesium deficiencies in cattle. The product is marketed under Vedco,
Inc., St. Joseph, MO, label.
AA. Mannitol 20%, 100-ml vials, Rx, intravenous administration, for use as
an osmotic diuretic in canine species. The product is marketed under the
following names and labels:
(1) MANNITOL 20% - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) MANNITOL INJECTION 20% - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH,
MO
BB. Saline Solution 0.9%, 100-ml, 250-ml, 500-ml, and 1000-ml vials, Rx and
OTC, intravenous or subcutaneous administration, for use in replacement therapy
of sodium, chloride and water which may become depleted in many diseases; for
use as a solvent or diluent for antibiotics and other pharmaceuticals and
biologicals; and for washing mucous membranes and other tissue surfaces.
This product is marketed under the following names and labels:
(1) SALINE SOLUTION 0.9% - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) SALINE SOLUTION 0.9% - CHAMPION PHARMACEUTICAL PRODUCTS, INC.,
PHOENIX, AZ
(3) SALINE SOLUTION 0.9% - LEXTRON, INC., GREELEY, CO
(4) SALINE SOLUTION 0.9% - L AND M PHARMACEUTICALS, DALLAS, TX
(5) SALINE SOLUTION 0.9% - J. A. WEBSTER, INC., STERLING, MA
(6) SALINE SOLUTION 0.9% - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
(7) SALINE SOLUTION 0.9% - A & G PHARMACEUTICALS, CLARKSBURG, NJ
(8) SALINE SOLUTION - IBA ANIMAL HEALTH DIV., MILLBURY, MA
(9) STERILE SALINE INJECTION - VICTOR MEDICAL CO., IRVINE, CA
(10) STERILE SALINE SOLUTION - HENRY SCHEIN, INC., PORT WASHINGTON, NY
(11) STERILE SALINE SOLUTION - DURVET, INC., BLUE SPRINGS, MO
(12) STERILE SALINE SOLUTION - RX VETERINARY PRODUCTS, PORTERVILLE, CA
(13) STERILE SALINE SOLUTION - UCKELE ANIMAL HEALTH CORP., BLISSFIELD,
MI
(14) NORMAL SALINE SOLUTION - EQUINE PRODUCTS OF AMERICA, INC., FT.
COLLINS,
CO
(15) NORMAL SALINE SOLUTION - VEDCO, INC., ST. JOSEPH, MO
(16) NORMAL SALINE SOLUTION - AGRI LABORATORIES, LTD., ST. JOSEPH, MO
(17) NORMAL SALINE SOLUTION - VIRBAC, INC., LENEXA, KS
(18) PHYSIOLOGICAL SALINE SOLUTION - THE BUTLER COMPANY, COLUMBUS,
OH
CC. Sodium Citrate Solution 2.5%, 250-ml vials, OTC, intravenous
administration, for use as an anticoagulant for preparing blood for
transfusion. The product is marketed under Veterinary Laboratories, Inc. and
L and M Pharmaceuticals, Dallas, TX., label.
DD. Sodium Iodide 20% Injection, 250-ml vials, Rx and OTC, intravenous
administration, for use as an aid in the treatment of actinomycosis (lumpy
jaw), actinobacillosis (wooden tongue) and necrotic stomatitis in cattle. The
product is marketed under the following names and labels:
(1) SODIUM IODIDE 20% INJECTION - VETERINARY LABORATORIES, INC., LENEXA,
KS
(2) SODIUM IODIDE 20% INJECTION - FARMLAND INDUSTRIES, KANSAS CITY, MO
(3) SODIUM IODIDE 20% INJECTION - L AND M PHARMACEUTICALS, DALLAS, TX
(4) SODIUM IODIDE 20% INJECTION - VICTOR MEDICAL CO., IRVINE, CA
(5) SODIUM IODIDE 20% INJECTION - VEDCO, INC., ST. JOSEPH, MO
(6) SODIUM IODIDE 20% INJECTION - AGRI LABORATORIES, LTD., ST. JOSEPH, MO
(7) SODIUM IODIDE 20% INJECTION - PHOENIX PHARMACEUTICAL, ST. JOSEPH,
MO
-10-
(8) SODIUM IODIDE INJECTION - EQUINE PRODUCTS OF AMERICA, FT. COLLINS,
CO
(9) SODIUM IODIDE 20% INJECTABLE SOLUTION - RX VETERINARY PRODUCTS,
PORTERVILLE, CA
(10) SODIUM IODIDE 20% - DURVET, INC., BLUE SPRINGS, MO
(11) SODIUM IODIDE SOLUTION 20% - THE BUTLER COMPANY, COLUMBUS, OH
(12) SODIUM IODIDE SOLUTION 20% - A & G PHARMACEUTICALS, CLARKSBURG,
NJ
(13) SODIUM IODIDE SOLUTION 20% - HENRY SCHEIN, INC., PORT WASHINGTON,
NY
(14) SODIUM IODIDE SOLUTION 20% - CHAMPION PHARMACEUTICAL PRODUCTS,
INC.,
PHOENIX, AZ
(15) SODIUM IODIDE SOLUTION 20% - UCKELE ANIMAL HEALTH DISTRIBUTING,
INC.,
BLISSFIELD, MI
EE. Sodium Pentobarbital Injection, 100-ml vials, Rx, intravenous
administration, for use as a general anesthetic, primarily in dogs and cats,
and for the symptomatic treatment of strychnine and other convulsant
poisonings. The product is marketed under the following names and labels:
(1) SODIUM PENTOBARBITAL INJECTION - VETERINARY LABORATORIES, INC.,
LENEXA, KS
(2) SODIUM PENTOBARBITAL INJECTION - BARBER VETERINARY SUPPLY CO.,
INC.,
RICHMOND, VA, AND FAYETTEVILLE, NJ
(3) SODIUM PENTOBARBITAL INJECTION - THE BUTLER COMPANY, COLUMBUS,
OH
(4) SOMNIFER - RICHMOND VETERINARY SUPPLY COMPANY, RICHMOND, VA
FF. Sodium Salicylate Injection 10%, 30-ml and 100-ml vials, Rx, intravenous
administration, for use as an analgesic and antipyretic agent in the management
of inflammatory disorders such as rheumatoid arthritis, muscle pain, and joint
pain. The product is marketed under the following names and labels:
(1) SODIUM SALICYLATE INJECTION 10% - VETERINARY LABORATORIES, INC.,
LENEXA, KS
(2) SODIUM SALICYLATE INJECTION 10% - A & G PHARMACEUTICALS,
CLARKSBURG, NJ
(3) SODIUM SALICYLATE INJECTION-10% - CHAMPION PHARMACEUTICAL
PRODUCTS, INC.,
PHOENIX, AZ
(4) SODIUM SALICYLATE INJECTION-100 MG - VICTOR MEDICAL CO., IRVINE, CA
(5) ASPRI-JECT INJECTION - VEDCO, INC., ST. JOSEPH, MO
GG. Sterile Water for Injection, 100-ml, 250-ml, and 500-ml vials, for use as
a diluent for the preparation of aqueous solutions. The product is marketed
under the following labels:
(1) VETERINARY LABORATORIES, INC., LENEXA, KS
(2) VICTOR MEDICAL CO., IRVINE, CA
(3) HENRY SCHEIN, INC., PORT WASHINGTON, NY
(4) J. A. WEBSTER, INC., STERLING, MA
(5) VEDCO, INC., ST. JOSEPH, MO
(6) PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
(7) RX VETERINARY PRODUCTS, PORTERVILLE, CA
(8) UCKELE ANIMAL HEALTH CORPORATION, BLISSFIELD, MI
(9) THE BUTLER COMPANY, COLUMBUS, OH
(10) VIRBAC, INC., LENEXA, KS
HH. Vitamin A D Injection, 100-ml, 250-ml, and 500-ml vials, OTC,
intramuscular administration, for use as a supplemental nutritive source of
vitamins A and D in cattle, sheep, and swine. The product is labeled under
the following names and labels:
(1) VITAMIN A D INJECTION - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) VITAMIN A D INJECTION - UNIVERSAL COOPERATIVES, INC., MINNEAPOLIS,
MN
(3) VITAMIN A D INJECTION - LEXTRON, INC., GREELEY, CO
-11-
(4) VITAMIN A D INJECTION - PREMIER FARMTECH, KANSAS CITY, MO
(5) VITAMIN AD INJECTION - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
(6) VITAMIN AD INJECTION - L AND M PHARMACEUTICALS, DALLAS, TX
(7) VITAMIN AD INJECTABLE - THE BUTLER COMPANY, COLUMBUS, OH
(8) VITAMIN A-D INJECTABLE - AGRI LABORATORIES, LTD., ST. JOSEPH, MO
(9) A-D INJECTION - DURVET, INC., BLUE SPRINGS, MO
(10) AD INJ-VITAMIN - RICHMOND VETERINARY SUPPLY CO., INC., RICHMOND, VA
(11) VITAMIN A & D - VEDCO, INC., ST. JOSEPH, MO
(12) VIT A & D 500 WITH VIT E - HENRY SCHEIN, INC., PORT WASHINGTON, NY
(13) VITAMIN A-D3 INJECTABLE - IBA, INC., MILLBURY, MA
(14) AD-5X INJECTABLE - UCKELE ANIMAL HEALTH DISTRIBUTING, BLISSFIELD,
MI
(15) VITA-JEC A & D "500" - RX VETERINARY PRODUCTS, PORTERVILLE, CA
II. Thiamine Hydrochloride Injection, 200 mg/ml and 250 mg/ml, 100-ml and
250-ml vials, Rx, intramuscular or subcutaneous administration, for use as a
supplemental nutritive source of thiamine (Vitamin B1) in cattle, horses,
sheep, swine, dogs and cats. The products are marketed under the following
names and labels:
200 mg/ml:
(1) THIAMINE HYDROCHLORIDE INJECTION - VETERINARY LABORATORIES, INC.,
LENEXA,
KS
(2) THIAMINE HYDROCHLORIDE INJECTION - VICTOR MEDICAL CO., IRVINE, CA
(3) THIAMINE HYDROCHLORIDE - VEDCO, INC., ST. JOSEPH, MO
(4) THIAMINE HCL - L AND M PHARMACEUTICALS, DALLAS, TX
250 mg/ml:
(1) THIAMINE-250 INJECTION - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) THIAMINE INJECTION - DURVET, INC., BLUE SPRINGS, MO
JJ. Vitamin C Injectable Solution, 100-ml and 250-ml vials, Rx and OTC,
intramuscular administration, for use as a nutritive supplement of Vitamin C
in cattle, horses, sheep, swine, dogs and cats. The product is marketed under
the following names and labels:
(1) VITAMIN C INJECTABLE SOLUTION - VETERINARY LABORATORIES, INC.,
LENEXA, KS
(2) VITAMIN C INJECTABLE SOLUTION - VET LABS LIMITED, INC., LENEXA, KS
(3) VITAMIN C INJECTABLE SOLUTION - AGRI LABORATORIES, LTD., ST. JOSEPH,
MO
(4) VITAMIN C INJECTABLE SOLUTION - A & G PHARMACEUTICALS,
CLARKSBURG, NJ
(5) VITAMIN C INJECTABLE SOLUTION - PHOENIX PHARMACEUTICAL, ST. JOSEPH,
MO
(6) VITAMIN C INJECTABLE SOLUTION - L AND M PHARMACEUTICALS, DALLAS,
TX
(7) VITAMIN C INJECTION - PHOENIX PHARMACEUTICAL, ST. JOSEPH, MO
(8) VITAMIN C INJECTABLE SOLUTION - VEDCO, INC., ST. JOSEPH, MO
(9) VITAMIN C - AGRI LABORATORIES, LTD., ST. JOSEPH, MO
(10) VITAMIN C - UNITED AGRI SERVICES, INC., MINNEAPOLIS, MN
(11) SODIUM ASCORBATE - DURVET, INC., BLUE SPRINGS, MO
(12) SODIUM ASCORBATE - RX VETERINARY PRODUCTS, PORTERVILLE, CA
(13) ASCORBIC ACID INJECTION - A & G PHARMACEUTICALS, CLARKSBURG, NJ
KK. Vitamin K1 Injection, 100-ml vials, Rx, intravenous, intramuscular, or
subcutaneous administration, for use in cattle, calves, horses, swine, sheep,
goats, dogs and cats to counter hypoprothrombinemia induced by ingestion of
Coumarin-based compounds or consumption of Bisydroxycoumarin found in spoiled
and moldy sweet clover. The products are marketed under the following names
and labels:
-12-
(1) VITAMIN K1 INJECTION - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) VITAMIN K1 INJECTION - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
(3) VITAMIN K1 INJECTION - THE BUTLER COMPANY, COLUMBUS, OH
(4) VEDA-K1 - VEDCO, INC., ST. JOSEPH, MO
(5) VITA-JEC VITAMIN K1 INJECTABLE - RX VETERINARY PRODUCTS,
PORTERVILLE, CA
LL. Injectable Tocopherol, 250-ml vial, OTC, intramuscular administration, for
use as an aid in the prevention and treatment of Vitamin E deficiencies. The
product is marketed under Stuart Products, Bedford, TX, label.
MM. Vitamin E Injectable, 100-ml vials, Rx and OTC, intramuscular
administration, for use as a supplemental nutritional source of vitamin E in
cattle, sheep, swine and dogs. The product is marketed under Veterinary
Laboratories, Inc. and Agri Laboratories, Ltd., St. Joseph, MO, labels.
NN. Injectable A-D-Tocopherol, 250-ml vial, Rx, intramuscular administration,
for use as a supplemental source of vitamins A, D, and E. The product is
marketed under Stuart Products, Bedford, TX, labels.
OO. Deca-Plex, 100-ml vials, Rx, intramuscular administration, for use as a
supplemental nutritional source of fat soluble and B complex vitamins. The
product is marketed under Veterinary Laboratories, Inc., Lenexa, KS, label.
PP. Vitamin B12 Injectable Solution; 1000 mcg/ml, 3000 mcg/ml, AND 5000
mcg/ml; 100-ml, 250-ml, and 500-ml vials; intravenous, intramuscular, or
subcutaneous administration, Rx, for use as an aid in the management of
Vitamin B12 deficiencies in cattle, swine, sheep, horses, dogs and cats.
The product is marketed under the following names and labels:
1000 mcg:
(1) VITAMIN B12 INJECTABLE SOLUTION - VETERINARY LABORTORIES, INC.,
LENEXA, KS
(2) VITAMIN B12 INJECTABLE SOLUTION - VEDCO, INC., ST. JOSEPH, MO
(3) VITAMIN B12 INJECTABLE SOLUTION - CHAMPION PHARMACEUTICAL
PRODUCTS, INC.,
PHOENIX, AZ
(4) VITAMIN B12 INJECTABLE SOLUTION - HENRY SCHEIN, PORT WASHINGTON,
NY
(5) VITAMIN B12 - L AND M PHARMACEUTICALS, DALLAS, TX
(6) VITAMIN B12 INJECTION - LEXTRON, GREELEY, CO
(7) VITAMIN B12 INJECTION - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
(8) VITAMIN B12 - 1000 INJECTION - EQUINE PRODUCTS OF AMERICA, INC., FT.
COLLINS, CO
(9) VITAMIN B-12 1000 INJECTION - A & G PHARMACEUTICALS, CLARKSBURG, NJ
(10) VITAMIN B12 CYANOCOBALAMIN INJECTION - AGRI LABORATORIES, LTD.,
ST.
JOSEPH, MO
(11) CYANOCOBALAMIN INJECTABLE SOLUTION - VICTOR MEDICAL CO., IRVINE,
CA
(12) CYANOCOBALAMIN INJECTION - ANTHONY PRODUCTS CO., ARCADIA, CA
(13) CYANOCOBALAMIN - THE BUTLER COMPANY, COLUMBUS, OH
3000 mcg:
(1) VITAMIN B12 INJECTION - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) VITAMIN B12 INJECTION - L AND M PHARMACEUTICALS, DALLAS, TX
(3) VITAMIN B12 INJECTION - WESTERN MEDICAL SUPPLY, INC., ARCADIA, CA
(4) VITAMIN B12 INJECTION - PRO LABS LTD., ST. JOSEPH, MO
(5) VITAMIN B12 INJECTABLE SOLUTION - CHAMPION PHARMACEUTICAL
PRODUCTS, INC.,
PHOENIX, AZ
-13-
(6) VITAMIN B12 - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
(7) VITAMIN B12 - VEDCO, INC., ST. JOSEPH, MO
(8) VITAMIN B12-3000 INJECTION - EQUINE PRODUCTS OF AMERICA, INC.,
FT. COLLINS, CO
(9) VITAMIN B-12 3000 INJECTION - A & G PHARMACEUTICALS, CLARKSBURG, NJ
(10) VITAMIN B12 INJECTION-3X - DURVET, INC., BLUE SPRINGS, MO
(11) VITA-JEC CYANO B12 INJECTABLE - RX VETERINARY PRODUCTS,
PORTERVILLE, CA
(12) CYANOCOBALAMIN INJECTION - ANTHONY PRODUCTS CO., ARCADIA, CA
(13) CYANOCOBALAMIN INJECTION - VICTOR MEDICAL CO., IRVINE, CA
(14) CYANOCOBALAMIN - THE BUTLER CO., COLUMBUS, OH
5000 mcg:
(1) VITAMIN B12 - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) VITAMIN B12 - VEDCO, INC., ST. JOSEPH, MO
(3) VITAMIN B12 - CHAMPION PHARMACEUTICAL PRODUCTS, INC., PHOENIX AZ
(4) VITAMIN B12 - A & G PHARMACEUTICALS, CLARKSBURG, NJ
(5) CYANOCOBALAMIN INJECTION - ANTHONY PRODUCTS CO., ARCADIA, CA
(6) CYANOCOBALAMIN - VICTOR MEDICAL CO., IRVINE, CA
QQ. Vita-Lyte Injection, 500-ml and 1000-ml vials, Rx, intravenous,
intraperitoneal, or subcutaneous administration, for use as a nutritive
supplement of B complex vitamins, electrolytes and dextrose in cattle, horses,
sheep, swine, dogs and cats. The product is marketed under the following
names and labels:
(1) VITA-LYTE INJECTION - VETERINARY LABORATORIES, INC., LENEXA, KS
(2) EQUI-PHAR VITA-LYTE - VEDCO, INC., ST. JOSEPH, MO
(3) EQUINE VITA-LYTE INJECTION - EQUINE PRODUCTS OF AMERICA, INC., FT.
COLLINS,
CO
(4) EQUI-B-LYTES INJECTION - VICTOR MEDICAL CO., IRVINE, CA
(5) AMINO BASE INJECTION - THE BUTLER COMPANY, COLUMBUS, OH
(6) MULTI-PLEX B INJECTION - CHAMPION PHARMACEUTICAL PRODUCTS,
PHOENIX, AZ
RR. High Potency Multi-B Complex Injectable; 100-ml, 250-ml, and 500-ml
vials; Rx and OTC, intramuscular or subcutaneous administration, for use as a
nutritive supplement of B complex vitamins. The product is marketed
under the following names and labels:
(1) HIGH POTENCY MULTI-B COMPLEX INJECTABLE - VETERINARY
LABORATORIES, INC.,
LENEXA, KS
(2) HIGH LEVEL VITAMIN-B COMPLEX/INJECTABLE - DURVET, INC., BLUE
SPRINGS, MO
(3) FORTIFIED VITAMIN B COMPLEX INJECTABLE - AGRI LABORATORIES LTD., ST.
JOSEPH, MO
(4) VITAMIN B COMPLEX INJECTION - EQUINE PRODUCTS OF AMERICA, INC., FT.
COLLINS, CO
(5) VITAMIN B COMPLEX FORTIFIED - PHOENIX PHARMACEUTICAL, ST. JOSEPH,
MO
(6) B-COMPLEX H.P. INJECTION - CHAMPION PHARMACEUTICAL PRODUCTS,
PHOENIX AZ
(7) VITA-B FORTE INJECTABLE - L AND M PHARMACEUTICALS, DALLAS, TX
(8) VITA-JEC VITAMIN-B COMPLEX INJECTABLE - RX VETERINARY PRODUCTS,
PORTERVILLE, CA
(9) FORTIFIED VITA-JEC B PLEX - RX VETERINARY PRODUCTS, PORTERVILLE, CA
(10) HI-PO B COMPLEX - THE BUTLER COMPANY, COLUMBUS, OH
-14-
SS. Vitamin B Complex Injectable; 100-ml, 250-ml, and 500-ml vials; Rx and
OTC, intramuscular administration, for use as a nutritive supplement of
B-complex vitamins. The product is marketed under the following names and
labels:
(1) VITAMIN B COMPLEX INJECTABLE - VETERINARY LABORATORIES, INC.,
LENEXA, KS
(2) VITAMIN B COMPLEX INJECTABLE - THE BUTLER COMPANY, COLUMBUS, OH
(3) VITAMIN B COMPLEX INJECTION - UCKELE ANIMAL HEALTH CORPORATION,
BLISSFIELD, MI
(4) VITAMIN B COMPLEX INJECTION - LEXTRON, INC., GREELEY, CO
(5) VITAMIN B-COMPLEX INJECTION - A & G PHARMACEUTICALS, CLARKSBURG,
NJ
(6) VITAMIN B COMPLEX INJECTABLE - AGRI LABORATORIES, LTD., ST. JOSEPH,
MO
(7) VITAMIN-B COMPLEX INJECTABLE - DURVET, INC., BLUE SPRINGS, MO
(8) VITAMIN B COMPLEX - VEDCO, INC., ST. JOSEPH, MO
(9) VITAMIN B COMPLEX - PHOENIX PHARMACEUTICAL, INC., ST. JOSEPH, MO
(10) VITAMIN-B COMPLEX - L AND M PHARMACEUTICALS, DALLAS, TX
(11) VITAMIN B COMPLEX FORTE - VEDCO, INC., ST. JOSEPH, MO
(12) VITA-B FORTE - VETERINARY LABORATORIES, INC., LENEXA, KS
(13) MULTI-B COMPLEX VITAMINS INJECTABLE - VETERINARY LABORATORIES,
INC.,
LENEXA, KS
(14) MULTI-B COMPLEX VITAMINS INJECTABLE - L AND M PHARMACEUTICALS,
INC.,
DALLAS, TX
(15) MULTI-B COMPLEX VITAMINS INJECTABLE - SOUTHEASTERN
LABORATORIES, INC.,
JACKSONVILLE, FL
(16) MULTI-B COMPLEX HIGH POTENCY - VET PRODUCTS CO., LENEXA, KS
(17) B-COMPLEX INJECTION - CHAMPION PHARMACEUTICAL PRODUCTS,
PHOENIX, AZ
(18) VITA-JEC B PLEX INJECTABLE - RX VETERINARY PRODUCTS, PORTERVILLE,
CA
TT. Estro IV Injection, 30-ml vials, Rx, intravenous or intramuscular
administration. The product is marketed under Champion Pharmaceutical
Products, Tempe, AZ, label.
UU. Yohimbine Hydrochloride, 5 mg/ml, 20-ml vials, Wildlife Laboratories,
Ft. Collins, CO. per their NADA. Recall #V-002/049-1.
Code: All lot numbers.
Manufacturer: Veterinary Laboratories, Inc., Lenexa, Kansas.
Recalled by: Manufacturer, by letter October 8, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Firm estimates little, if any, of the products remain
on the market.
Reason: Nonconformance with current manufacturing practice
regulations and subsequent failure of retrospective
autoclave validation.
----
Class III -
NONE
-15-