October 30, 2002
02-43
_____________________________
PRODUCT
Mini Fruit Jellies, all flavors,
in sizes 53 oz. jars; 10.5 oz. poly
bags. Brand name is "JoeLee" where
the "o" is a happy face.
a) Mango Flavor. Recall # F-016-3;
b) Lychee Flavor. Recall # F-017-3;
c) Assorted Flavor. Recall # F-018-3;
d) Grape Flavor. Recall # F-019-3;
e) Strawberry Flavor. Recall # F-020-3;
f) Peach Flavor. Recall # F-021-3;
g) Pineapple Flavor. Recall # F-022-3.
CODE
All products on the market at
the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Joaly Enterprise
Company, La Mirada, CA, by press
release and letters on January 7,
2002.
Manufacturer: Jojomo Enterprise Co.
Ltd., Chang-Hua, Taiwan. Firm initiated
recall is ongoing.
REASON
This type of candy is in violation
of section 402 (a)(3) of the Federal
Food, Drug, and Cosmetic Act in that
it is unfit for food due to the characteristics
that result in a serious choking
hazard.
VOLUME OF PRODUCT IN COMMERCE
138,804 cases in 2001.
DISTRIBUTION
AZ, CA, FL, NC, NV, NY and TX.
_____________________________
PRODUCT
Mini Gel Candies. The candies
were sold under the brand names New
Choice Mini Fruit Gels, Yummy Choice
Fruit Gel Snacks, and Sheng Hsiang
Jen (chinese label) Conjac Coconut
jell. The products were sold in the
following flavors:
a) Apples. Recall # F-023-3;
b) Grape. Recall # F-024-3;
c) Taro. Recall # F-025-3;
d) Lychee. Recall # F-026-3;
e) Peach. Recall # F-027-3;
f) Pineapple. Recall # F-028-3;
g) Mango. Recall # F-029-3;
h) Orange. Recall # F-030-3;
i) Lemon. Recall # F-031-3;
j) Strawberry. Recall # F-032-3;
k) Assorted. Recall # F-033-3.
The candies were sold in bags containing
18 units per bag and shipped 30 bags
per case. The candies were also sold
in plastic jars containing 88 units
per jar and shipped 6 jars per case.
CODE
All products on the market at
the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Santi and Sons,
Reading, PA., by press release on
July 23, 2002 followed by visit.
Manufacturer: Sheng Hsiang Jen Foods
Co. Ltd, Taiwan, Republic of China.
FDA initiated recall is complete.
REASON
This type of candy is in violation
of section 402 (a)(3) of the Federal
Food, Drug, and Cosmetic Act in that
it is unfit for food due to the characteristics
that result in a serious choking
hazard.
VOLUME OF PRODUCT IN COMMERCE
1642296 individual units.
DISTRIBUTION
PA and DE.
_____________________________
PRODUCT
Luokeng Fresh Bamboo Shoot packaged
in a vacuum packed, flexible plastic
bag, net wt. 17.05 ozs. Recall #
F-013-3.
CODE
All products on the market at
the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ADCO (USA) Inc.,
Brooklyn, NY, by letter dated October
2, 2001.
Manufacturer: Xinhui Foodstuffs Co.,
Xinhui City, China.
State initiated recall is complete.
REASON
The product appears to be a low-acid
food capable of supporting growth
of C. botulinum.
VOLUME OF PRODUCT IN COMMERCE
26 cases (30 - 17.5 oz. packages
per case).
DISTRIBUTION
NY.
_____________________________
PRODUCT
Alaska Supreme brand ice cream
in 1/2 gallon containers.
Flavors include:
a) Base Camp Coffee. Recall # F-034-3;
b) Chocolate. Recall # F-035-3.
CODE
All codes up to MAY 16 2003.
RECALLING FIRM/MANUFACTURER
Alaska Supreme Ice Cream Co.,
Anchorage, AK, by visit beginning
August 19, 2002. FDA initiated recall
is complete.
REASON
The products contained the undeclared
color FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
Approx. 52 gallons.
DISTRIBUTION
AK.
_____________________________
PRODUCT
Apple juice labeled in part "Minute
Maid APPLE JUICE***16 FL OZ*** PASTEURIZED***MANUFACTURED
UNDER THE AUTHORITY OF THE MINUTE
MAID COMPANY A DIVISION OF THE COCA-COLA
COMPANY, HOUSTON, TX 77252". Packaged
in 16-oz plastic bottles 24 per case.
Recall # F-014-3.
CODE
Product labeled with code JAN1303WTB2CAL
x (x=Military Times ranging from
1800-0105).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Minute Maid Company,
Houston, TX, by letter on March 15,
2002.
Manufacturer: Minute Maid, Waco,
TX. Firm initiated recall is complete.
REASON
Apple juice contains mold.
VOLUME OF PRODUCT IN COMMERCE
24,695 cases.
DISTRIBUTION
NM, TX, LA, AZ and OK.
_____________________________
PRODUCT
Fluocinonide Cream USP, 0.05%,
Rx only, 15g (0.53oz), 30g (1.1oz),
and 60g (2.2oz) tubes. Recall # D-029-3.
CODE
Lot#: L106046, L106047, L106048,
L108101, L108102, L108103, L110094,
L110095, L110096, L202079.
RECALLING FIRM/MANUFACTURER
Alpharma Uspd, Inc., Lincolnton,
NC, by letters on September 30, 2002.
Firm initiated recall is ongoing.
REASON
Product exceeded specification
for degradant level (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
63852 units, various sizes.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Select Brand®, Night-Time
Adult Cold Medicine, Original Flavor,
6 FL. OZ. (177 mL), clear plastic
triangular bottle. Recall # D-036-3.
CODE
051L1C, Exp 12/04.
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, Inc.,
Huntsville, AL, by letter dated August
20, 2002. Firm initiated recall is
ongoing.
REASON
Subpotent for one active ingredient-pseudoephedrine
hydrochloride-by manufacturer (6
month stability).
VOLUME OF PRODUCT IN COMMERCE
35,963 bottles.
DISTRIBUTION
AK.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced,
Recall # B-0066-3.
CODE
Unit number KC00846.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems,
Inc., Scottsdale, AZ, by letter dated
April 24, 2002.
Manufacturer: Tri-Counties Blood
Bank, Santa Barbara, CA.
Firm initiated recall is complete.
REASON
Blood product, collected from
an unsuitable donor based on travel
to an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced.
Recall # B-0067-3.
CODE
Unit number 06GH67260.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,
Southern California Region, Los Angeles,
CA, by letter dated February 15,
2002.
Firm initiated recall is complete.
REASON
Blood product, collected from
an unsuitable donor based on travel
to an area considered endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Counterfeit Procrit_ (Epoetin
alfa), labeled as 40000 unit/ml vials,
4 vials/box. Recall # B-0068-3.
CODE
Lot numbers P002641 and P002384.
RECALLING FIRM/MANUFACTURER
AmeriSourceBergen Corporation,
Orange, CA, by letter on June 12,
2002. Firm initiated recall is complete.
REASON
Counterfeit drug product, with
a concentration of active ingredient
less than labeled, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 lots.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced. Recall # B-0069-3;
b) Red Blood Cells, Leukocytes Reduced
Irradiated. Recall
B-0070-3.
CODE
a) Unit number 0664309;
b) Unit number 0664306.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers
of the Pacific, Irwin Center, San
Francisco, CA., by letter dated August
13, 2001.
Manufacturer: Blood Centers of the
Pacific, Peninsula/South Bay Center,
Burlingame, CA. Firm initiated recall
is complete.
REASON
Blood products, collected from
a donor whose hemoglobin test was
incorrectly documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-0072-3;
b) Cryoprecipitated AHF. Recall #
B-0073-3.
CODE
a) and b) Unit number FJ93945.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services,
Inc., dba Rhode Island Blood Center,
Providence, RI, by telephone on June
18, 2002.
Firm initiated recall is complete.
REASON
Blood products, that tested negative
for hepatitis, but were collected
from an ineligible donor due to a
subsequent disclosure of previous
positive hepatitis testing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
RI.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-0074-3;
b) Recovered Plasma, Recall # B-0075-3.
CODE
a) and b) Unit number 04KK60295.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,
New England Region, Dedham, MA, by
letters on July 22, 2002 and August
15, 2002. Firm initiated recall complete.
REASON
Blood products, that tested negative
for the antibody to hepatitis C virus
(anti-HCV), but were collected from
an ineligible donor based on the
disclosure of a previous positive
test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VT and CA.
_____________________________
PRODUCT
Fresh Frozen Plasma, Recall #
B-0076-3
CODE
Unit LX00037.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems,
Inc., Scottsdale, AZ, by telephone
on December 27, 2001.
Manufacturer: Tri-Counties Blood
Bank, Santa Barbara, CA.
Firm initiated recall is complete.
REASON
Blood product, collected from
a donor on Coumadin therapy, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced.
Recall # B-0065-3.
CODE
Units 29GW35656, 29GW35253.
RECALLING FIRM/MANUFACTURER
American Red Cross, Mid-Atlantic
Regional Blood Services, Norfolk,
VA, by letters dated April 22 and
May 22, 2002.
Firm initiated recall is complete.
REASON
Blood products, collected from
an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.
_____________________________
PRODUCT
Fresh Frozen Plasma, Recall #
B-0071-3
CODE
Unit numbers 0664309 and 0664306.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers
of the Pacific, Irwin Center, San
Francisco, CA, by letter dated August
13, 2001.
Manufacturer: Blood Centers of the
Pacific, Peninsula/South Bay Center,
Burlingame, CA. Firm initiated recall
is complete.
REASON
Blood products, collected from
a donor whose hemoglobin test was
incorrectly documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
____________________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced. Recall # B-0079-3;
b) Platelets Pheresis, Leukocytes
Reduced.
Recall # B-0080-3.
CODE
a) Unit numbers 012L70114 and
012L70118;
b) Unit numbers 012GW22709, 012GW22710,
012GW22711,
012GW22712, 012GW22714 (distributed
as two split units),
012GW22716, 012GW22717, 012GW22718,
012GW22719
(distributed as two split units),
012GW22720,
012GW22721, and 012GW22722.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,
Carolinas Region, Charlotte, NC,
by telephone on June 24 and 25, 2002
and by letter dated July 5, 2002.
Firm initiated recall is complete.
REASON
Blood products, incorrectly tested
for antibodies to hepatitis C virus
(anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
MO, NC and TN.
_____________________________
PRODUCT
Aesculap Ti Bone Screws, 4x56
mm. Recall # Z-0116-3.
CODE
Lot number 5634922.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aesculap, Inc.,
Center Valley, PA, by letters dated
June 14, 2002.
Manufacturer: Aesculap Ag & Co.
Kg. Tuttlingen, Donau, Germany. Firm
initiated recall is complete.
REASON
Smaller than specified core diameter
may lead to screw breakage during
and post-implantation.
VOLUME OF PRODUCT IN COMMERCE
55 units.
DISTRIBUTION
FL, NJ, and UT.
_____________________________
PRODUCT
a) Meridian Medical Systems (MMS)
brand Wye-Swivel, Plain;
Part/Model Number 020104347. Recall
# Z-0121-3;
b) Meridian Medical Systems (MMS)
brand Wye-Swivel, GSP;
Part/Model Number 020104348. Recall
# Z-0122-3.
CODE
a) Lots 347270402, 352940502,
355440502, 355630502,
357260502, 356960502, 35810602 and
357270502;
b) Lots 353390502, 356160502, 357290502
and 357280502.
RECALLING FIRM/MANUFACTURER
Meridian Medical Systems, Inc.,
Indianapolis, IN, by letter dated
September 18, 2002. Firm initiated
recall is complete.
REASON
Swivel leg may crack and leak
at connection with the body.
VOLUME OF PRODUCT IN COMMERCE
138,600 wyes.
DISTRIBUTION
Costa Rica.
_____________________________
PRODUCT
Fabius GS Anesthesia Gas Machine.
Recall # Z-0123-3.
CODE
Catalog number 4117110.
RECALLING FIRM/MANUFACTURER
Drager Medical, Telford, PA,
by letter on August 14, 2002.
Firm initiated recall is ongoing.
REASON
Intermittent leaks associated
with APL valve.
VOLUME OF PRODUCT IN COMMERCE
764 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
0.5cc 30G x 5/16 Walgreens brand
syringes (cases of 5 boxes of 100
or boxes of 100 each)and .5cc 29GA
x 1/2" (12.7mm) insulin syringe.
Recall # Z-0125-3/Z-0126-3.
CODE
Catalog No.; Walgreens: 676987,
BD's: 928854
Lot Codes:
8742; 8743; 8779; 8780; 8781; 8782;
8783;
8784; 8785; 8786; 8804; 8814; 8815;
8816.
Catalog No.: Walgreens: 677258, BD's
928851
Lot Codes:
8230; 8764; 8765; 8766; 8774; 8775;
8776;
8777; 8787; 8795; 8796; 8797; 8798;
8799;
8800; 8801; 8802; 8803; 8805; 8806;
8807;
8808; 8809; 8822.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson
& Co., Franklin Lakes, NJ, by
letter on September 6, 2002 and October
3, 2002.
Manufacturer: Boin Medica Co. Inc.,
Kumi City, Kyungbuk, Korea. Firm
initiated recall is ongoing.
REASON
Product has a recessed cannula
which makes it difficult to remove
the bubbles.
VOLUME OF PRODUCT IN COMMERCE
8,683,000 devices.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
SynchroMed EL Implantable Infusion
Pumps, Models 8626-10, 8626L-10,
8627-10, 8627L-10, 8626-18, 8626L-18,
8627-18, and 8627L-18. Recall # Z-0127-3/Z-0134-3.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Neurological
Division, Minneapolis, MN, by letter
dated September 2002. Firm initiated
recall is ongoing.
REASON
Inadequate directions for use.
VOLUME OF PRODUCT IN COMMERCE
55,000 pumps (about 46,000 in
the U.S. and 9,000 in foreign countries).
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
SABRE Bioabsorbable Polymer Sling
With Introducer, catalog numbers
93-1030 (1.0 cm x 3.0 cm sling) and
93-1575 (1.5 cm x 7.5 cm sling) and
SABRE Introducer, catalog number
93-1000. Recall # Z-0135-3.
CODE
All lot numbers of catalog numbers
93-1000, 93-1030 and 93-1575, distributed
prior to the recall, are affected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mentor Minnesota
Inc., Minneapolis, MN., by telephone
on September 27 and 28, 2002 and
by letter on September 27, 2002.
Manufacturer: Prosurg Inc., San Jose,
CA. Firm initiated recall is ongoing.
REASON
Holes observed in the sterile
packaging.
VOLUME OF PRODUCT IN COMMERCE
379 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Lorenz brand 99-7215-01 Low Profile
Center Drive 1.5X15mm Titanium Screw.
Sold one per package and 5 per package.
Recall # Z-0136-3/Z-137-3.
CODE
Lot Numbers 206770, 163140, 132960,
113440, 113450, 098740.
RECALLING FIRM/MANUFACTURER
Walter Lorenz Surgical, Inc.,
Jacksonville, FL, by telephone on
May 23, 2002 and by letter June 4
-7, 2002.
Firm initiated recall is complete.
REASON
Screws were not fully cleaned
per current SOP's before distribution.
VOLUME OF PRODUCT IN COMMERCE
193.
DISTRIBUTION
Nationwide and Canada, Germany
and Japan.
_____________________________
PRODUCT
Perry Baromedical Hyperbaric
Chambers- SIGMA MP Multiplace Hyperbaric
Oxygen Treatment Chambers. These
prescription devices are used in
hospitals and clinics to treat multiple
patients at a time for conditions
such as air or gas embolism, gas
gangrene, necrotizing soft tissue
infections and thermal burns. Recall
# Z-0139-3.
CODE
All codes/serial numbers involved.
RECALLING FIRM/MANUFACTURER
Perry Baromedical Corporation,
Riviera Beach, FL, by letter on June
11, 2001. FDA initiated recall is
ongoing.
REASON
Change testing of Fire Suppression
System to monthly.
VOLUME OF PRODUCT IN COMMERCE
18.
DISTRIBUTION
Nationwide and Canada.
_____________________________
PRODUCT
INTRALASE FS 600 C Laser System
(Model 1), Laser Keratome. Recall
# Z-0147-3.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
IntraLase Corporation, Irvine,
CA, by letter dated October 2, 2002.
FDA initiated recall is ongoing.
REASON
Design defect, wire breakage,
causes laser failure, interrupting
surgery.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
Nationwide and Mexico.
****CORRECTION****
The Enforcement report 02-42, for
10/23/02, Recall # Z-0110-03, Vistacon,
one of the lot numbers was listed
incorrectly. The Lot listed as "B000WJK(XXX
)" should be listed as "Lot B000WJP
(XXX )(-5.00D, 8.7 B.C.)".
_____________________________
PRODUCT
Palco Laboratories brand Pulse
Oximeter; Models: 100, 130, and Aero
(non-medical pulse oximeter)
a) For Model 100 Product Number is:
1001010.
Recall # Z-0118-3;
b) For Model 130, Product Number
is: 1001013.
Recall # Z-0119-3;
c) For AERO Model, Product Number
is: 1001012.
Recall # Z-0120-3.
CODE
For Serial Numbers:
a) Serial Numbers are:
1270000001 to 1270000382 (may contain
-01 at the end)
12700100001 to 12700100775;
b) Serial Numbers are:
1030000001 to 1030000055 (number
may contain -01
at the end);
c) Serial Numbers are:
1260000001 to 1260000026 (number
may contain -01
at the end)
12600100001 to 12600100045.
RECALLING FIRM/MANUFACTURER
Palco Laboratories, Inc., Santa
Cruz, CA, by letters on August 27,
2002. Firm initiated recall is ongoing.
REASON
A capacitor was loaded backwards
into the Pulse Oximeter.
VOLUME OF PRODUCT IN COMMERCE
1050 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Access 2 Immunoassay Systems
-- Systems Software
Versions 1.0; 1.1; 1.2; and 1.3.1.
Recall # Z-0124-3.
CODE
Product Name: Access 2 Software
Part Number: 973074
Lot Number |
Software Version |
---|---|
212702 |
1.3.1 |
212701 |
1.3.1 |
211403 |
1.3 |
210332 |
1.3 |
210331 |
1.3 |
108609 |
1.2 |
108104 |
1.2 |
107317 |
1.2 |
106682 |
1.2 |
106447 |
1.2 |
106146 |
1.1 |
105903 |
1.1 |
105270 |
1.1 |
104958 |
1.1 |
104485 |
1.1 |
103905 |
1.0 |
103436 |
1.0 |
103010 |
1.0. |
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea,
CA, by letters on June 12, 2002.
Firm initiated recall is ongoing.
REASON
Erroneous result flags can result
on printed reports and screen displays
in rare circumstances.
VOLUME OF PRODUCT IN COMMERCE
442.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Vortex Port-LP Access System
with Attachable Catheter. Recall
# Z-0138-3.
CODE
REF P12155, LOT 981201, 2003-12
EXPIRATION DATE.
RECALLING FIRM/MANUFACTURER
Recallinf Firm: Horizon Medical
Products, Inc., Manchester, GA, by
visit in January 2001.
Manufacturer: Norfolk Medical Products,
Inc., Skokie, IL.
Firm initiated recall is ongoing.
REASON
Mislabeling of Vortex Port-LP
Access System with Attachable Catheter.
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
AL, FL, IN, MK, NY, PA and TX.
_____________________________
PRODUCT
INTERLASE FS 600 C Laser System
(Model 1), Laser Keratome. Recall
# Z-0140-3.
CODE
All units.
RECALLING FIRM/MANUFACTURER
IntraLase Corp., Irvine, CA,
by letters dated October 2, 2002.
Firm initiated recall is ongoing.
REASON
Cooling system problem causes
machine to become inoperable.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
Nationwide and Mexico.
_____________________________
PRODUCT
"FrameLock" device, Product Number
960-808, intended for intra-operative
use with the LandmarX Image Guided
Surgery System as a device to regidly
mount a reference arc to a patient's
skull. The product has an open cannula
nut which is missing for the referenced
lot number. The kit is packaged in
a metal sterilization tray which
is wrapped in plastic. Recall # Z-0146-3.
CODE
Lot 23353200.
RECALLING FIRM/MANUFACTURER
Xomed, Inc., Jacksonville, FL,
by letter dated September 4, 2002.
Firm initiated recall is ongoing.
REASON
Framelock assemblies packed with
Open Cannula Nuts.
VOLUME OF PRODUCT IN COMMERCE
22.
DISTRIBUTION
Nationwide and France, the Netherlands
and Japan.
END OF ENFORCEMENT REPORT FOR OCTOBER 30, 2002
####
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