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
07/21/1993
Recalls and Field Corrections: Foods -- Class I -- 07/21/1993
July 21, 1993
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
=========================
_______________
PRODUCT Nutritional beverage powders, complete
supplementary foods for infants and
children, and meal replacement powdered
beverages manufactured at Maple Island
Inc.'s Wanamingo, Minnesota facility
between 11/4/92 and present as follows:
(a) Promil Supplementary Food for
Infants and Children;
(b) Enercal Plus Complete, total
nutritional beverage powder, natural
flavor;
(c) Enercal Plus Complete, total
nutritional beverage powder, vanilla
flavor;
(d) Enercal Complete Balanced
Nutritional Beverage Powder, natural
flavor;
(e) Enercal Complete Balanced
Nutritional Beverage Powder, Vanilla
Flavor;
(f) Enercal Complete Balanced
Nutritional Beverage Powder, Chocolate
flavor. Products were packaged in 400
gm, 450 gm, 900 gm, and 1000 gm cans
and in 54.2 gm, 57.2 gm, and 78.9 gm
sachets. Recall #F-509/514-3.
CODE Lot numbers: Thailand - Promil KG
T09NDA V11NDA A20SDA
C18SDA
T09NDB V11NDB A20SDB
C18SDB
T09NDC V11NDC A20SDC
C24SDC
T09NDD V11NDD A21SDA
C24SDD
T09NDE V11NDE A21SDB
C24SDE
T09NDF V14NDA A21SDC
C24SDF
T10NDA V14NDB A21SDD
C24SDG
T10NDB V14NDC A22SDA
C24SDH
T10NDC V16NDA A22SDB
C25SDA
T11NDA V16NDB A22SDC
C25SDB
T11NDB V21NDA A22SDD
C25SDC
T11NDC V21NDB A25SDA
C25SDD
T11NDD V21NDC A25SDB
C25SDE
T13NDA V21NDD A25SDC
D15SDA
T13NDB V21NDE A25SDD
D15SDB
V21NDF C16SDA
V21NDG C16SDB
V22NDA C16SDC
V22NDB C16SDD
V22NDC C17SDA
V22NDD C17SDC
V22NDE
V22NDF
V22NDG
Thailand - Promil 450 GM -- V07NDB,
C12SDA, V07NDC, C12SDB, V07NDD, C12SDC,
V07NDE, D22SDB, V08NDA, D22SDC, V16NDA,
V16NDB, C09SDA, C09SDB, C09SDC, C10SDA,
C10SDB, C10SDC, C11SDA, C11SDB, C11SDC.
Malaysia - Enercal:
Chocolate 400 GM -- T04NDC, T04NDE,
T04NDD;
900 GM -- T04NDA, T04NDB,
T04NDC;
T11NDG, T11NDH;
57.2 GM Sachet -- T05NCB
Vanilla 400 GM -- T05NDC, T05NDD;
54.5 GM -- T05NCA
Natural 400 GM -- T12NDC, T12NDD,
900 GM -- T11NDE, T11NDF,
T12NDA, T12NDB,
T12NDC
Plus Vanilla 78.9 GM. Sachet -- A21NCA,
A22NCA
Hong Kong - Enercal:
Chocolate 900 GM -- A04SDB,
Natural 400 GM -- V17NDE, V17NDF
900 GM -- V08NDC, V08NDB,
Plus Natural 400 GM -- V16NDD
Plus Vanilla 400 GM -- V17NDC, T05NDA,
T05NDB
Taiwan - Enercal:
Plus Natural 400 GM -- V16NDC, V16NDD
Plus Vanilla 400 GM -- T05NDB, V17NDC,
V17NDD, T05NDB
Vanilla 900 GM -- V15NDB, V15NDC,
V09NDB, V09NDA,
V15NDA, V08NDD
Singapore - Enercal:
Natural 400 GM -- V17NDF
Plus Natural 400 GM -- V16NDC
MANUFACTURER Maple Island, Inc., Wanamingo,
Minnesota.
RECALLED BY Wyeth-Ayerst International, Inc., St.
Davids, Pennsylvania, by letter July 1,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Taiwan, Malaysia, Singapore, Dominican
Republic, Hong Kong, Thailand.
QUANTITY 1096992 units were distributed.
REASON Products manufactured under conditions
in which they may have become
contaminated by salmonella.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
_______________
PRODUCT Medibase and Medibase-II meal
replacement drinks, Cambridge Food for
Life meal replacement drinks,
nutritional drink, and high fiber oat
cereal manufactured since November 4,
1992, at Maple Island, Inc.'s (MII)
Wanamingo, MN facility:
(a) MediBase-II Meal Replacement Drink
(MRD) Vanilla Flavored, 22.6 ounces;
(b) MediBase MRD Chocolate Flavored,
22.6 ounces;
(c) MediBase-II MRD Chocolate Flavored,
22.6 ounces;
(d) Cambridge Diet MRD French Vanilla
Flavored, 24.8 ounces;
(e) Cambridge Diet MRD Dutch Chocolate
Flavored, 24.8 ounces;
(f) Cambridge Diet MRD Strawberry
Flavored, 24.8 ounces;
(g) Cambridge Diet MRD Vanilla Shake
Flavored, 24.8 ounces;
(h) Cambridge Food for Life Nutritional
Drink (FLND) Vanilla Flavored, 21.4
ounces;
(i) Cambridge (FLND) Chocolate
Flavored, 21.4 ounces;
(j) Cambridge Food for Life Strawberry
Flavored Nutritional Drink, 21.4
ounces;
(k) Cambridge Food for Life Super Oats
Nutritional Hi-Fiber Cereal Mix, 26.15
ounces. Recall #F-515-525-3.
CODE Lot numbers: (a) V8W 03173; (b) FCW
04203; (c) C8W 12022;
(d) VNW 01193, (e) DCW 12022, DCW
01183, DCW 01193,
DCW 04203; (f) STW 01183; (g) VSW
04203; (h) FVW 12022,
FVW 01193, FVW2 01193; (i) FCW 12022,
FCW 01183, FCW 04203; (j) FSW 01183,
FSW 01192; (k) CLW 01193.
MANUFACTURER Maple Island, Inc., Wanamingo,
Minnesota.
RECALLED BY Dean Distributors, Burlingame,
California, by letter July 7, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 42,734 cans of Cambridge products and
597 cans of the Medi-Base products were
distributed.
REASON The products were manufactured under
conditions in which they may have
become contaminated by Salmonella.
_______________
PRODUCT Clements Star*Light Cake Donut Mix, in
50 pound paper bags. Recall #F-534-3.
CODE 528.
MANUFACTURER Clements Donut Flour Company, Conway,
Arkansas.
RECALLED BY Manufacturer, by visit, June 7, 1993.
Firm-initiated field correction
(relabeling) complete.
DISTRIBUTION Arkansas.
QUANTITY Firm estimates none remains on the
market.
REASON Product contains undeclared FD&C Yellow
No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
=======================
_______________
PRODUCT Groff's Thin & Crusty No Salt Potato
Chips, in 6 ounce bags. Recall #F-535-
3.
CODE All lots.
MANUFACTURER Groff's Snack Food Company, Inc.,
Bowmansville, Pennsylvania.
RECALLED BY Manufacturer, by letter May 25, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, New York, New
Jersey.
QUANTITY 30-75 cases (12 bags per case) were
distributed.
REASON Label states potatoes in peanut oil,
product is made with cottonseed oil.
_______________
PRODUCT Natural Mountain Spring Water from the
Allegheny Highland, in 16 ounce plastic
bottles. Recall #F-536-3.
CODE Lot #008BS31021.
MANUFACTURER A. Smith Bowman Distillery,
Fredericksburg, Virginia.
RECALLED BY Bath Spring Water, Inc., Arlington,
Virginia. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 1,296 cases (24 bottles per case) were
distributed.
REASON Product was contaminated with mold.
_______________
PRODUCT Teriyaki Sauce, in 1-gallon cans with
metal screw caps. Recall #F-538-3.
CODE 10/92 (date of production).
MANUFACTURER Eagle Spice and Extract Company, Inc.,
Brooklyn, New York.
RECALLED BY Manufacturer. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 420 cans were distributed.
REASON Product is contained in detinning cans.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT Lopid (Gemfibrozil) Tablets, 600 mg, in
bottles of 500, Rx preparation.
Recall #D-295-3.
CODE Lot #05013 EXP 12/94.
MANUFACTURER Warner Lambert, Inc., Vega Baja, Puerto
Rico.
RECALLED BY Parke Davis, Division of Warner Lambert
Company, Morris Plains, New Jersey, by
letter June 11, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,489 units were distributed.
REASON Some bottle labels lack the lot number
and expiration date.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT Laser Marking Systems: Script, Script
100, Signature, Signature 100,
industrial laser marking systems used
to engrave parts made of various
materials.
Recall #Z-585/588-3.
CODE Serial numbers: Undetermined.
MANUFACTURER Control Laser Systems, Orlando,
Florida.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan June 1, 1993.
Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 37 units.
REASON Defective solenoids.
_______________
PRODUCT Softscan Model 200 Laser product used
for the relief of pain. Recall #Z-632-
3.
CODE Model 200.
MANUFACTURER Mountain West Medical Industries, Inc.,
Broomfield, Colorado.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan June 21, 1993.
Firm-initiated field correction
ongoing.
DISTRIBUTION Colorado, Massachusetts, New York, New
Jersey, Georgia, Ohio, Michigan,
Wyoming, California.
QUANTITY 11 units.
REASON Manufacturer failed to provide each
purchaser a procedure and schedule for
calibration of the measurement system
and the user information did not
contain the required caution statement.
_______________
PRODUCT Nidek nd:YA Ophthalmic Laser System, a
medical laser product for use in
ophthalmology. Recall #Z-633-3.
CODE Model YC-300.
MANUFACTURER Nidek, Inc., Fremont, California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan June 12, 1993.
Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12 units.
REASON Manufacturer failed to provide each
purchaser a calibration procedure for
the laser products measurement system.
_______________
PRODUCT Models PAS 2500 and PAS 500 Series
Wafer Springs, industrial laser
products used in the manufacture of
integrated circuits. Recall #Z-
634/635-3.
CODE PAS 2500 and PAS 5000 Series.
MANUFACTURER ASM Lithography, Inc., Tempe, Arizona.
RECALLED BY Manufacturer. FDA approves the firm's
corrective action plan June 10, 1993.
Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 150 units.
REASON Noninterlocked protective housing
labels were not visible prior to
opening protective housing.
_______________
PRODUCT Intraocular Lenses (IOLs). Recall ##Z-
636-3.
CODE Model Number UPB350FNS, lot #0544.
Serial Numbers:
02717 02738 04554 04589 05572
02718 02739 04555 04590 02719
04477 04556 04591 02721 04478
04557 04592 02722 04479 04558
04594 02723 04480 04563
04595 02724 04481 04564 04597
02725 04482 04565 04598 02726
04483 04566 04600 02727 04484
04567 05551 02728 04485 04568
05552 02729 04486 04569 05557
02730 04487 04570 05559 02731
04542 04572 05560 02732 04544
04573 05561 02733 04545 04576
05563 02734 04546 04577 05564
02735 04548 04578 05565 02736
04549 04579 05568 02737 04553
04586 05571 Use Before Date: 12-95.
MANUFACTURER Ioptex Research, Inc., Irwindale,
California.
RECALLED BY Manufacturer, by letter dated November
3, 1992. Firm-initiated recall
complete.
DISTRIBUTION Arizona, California, Colorado,
Connecticut, Delaware, Florida,
Georgia, Kentucky, Louisiana,
Massachusetts, Maryland, New Jersey,
Nevada, New York, Oklahoma,
Pennsylvania, Rhode Island, Tennessee,
Texas, Australia.
QUANTITY 111 units were distributed.
REASON 81 lenses are potentially mislabeled.
Implantation of a lens could result in
refractive error.
_______________
PRODUCT Bio-Medicus Bio Cal 370 Series
Heater/Cooler, a thermal transfer
module designed to control patient
blood temperatures during
cardiopulmonary bypass procedures.
Recall #Z-641-3.
CODE All serial numbers.
MANUFACTURER Medtronic Bio-Medicus, Inc., Eden
Prairie, Minnesota.
RECALLED BY Manufacturer, by letter March 31, 1993.
Firm-initiated field corrections
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 430 units were distributed.
REASON The device is rendered inoperative due
to a time dependent failure mechanism
in the unit's Liquid Level Sensor Part
Number 66151. Time to failure (mean
time) is one year. Product labeling
does not include any reference to the
use of a back-up unit in the event of
Model 370 failure.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
====================== _______________
PRODUCT Deknatel Custom Procedure Pak, polydek
suture size 2-0.
Recall #Z-616-3.
CODE Catalog #V1259, lot numbers 02619 and
02642P.
MANUFACTURER Deknatel, Inc., Fall River,
Massachusetts.
RECALLED BY Manufacturer, by telephone and by
letter dated January 29, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Virginia.
QUANTITY 7 boxes (12 units per box) were
distributed.
REASON The inner primary labeling incorrectly
identified the needle inside.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS --
CLASS II ==========
_______________
PRODUCT (a) Penicillin G Procaine, Sterile
Aqueous Suspension (injectable), in 100
ml, 250 ml, and 500 ml multiple dose
vials, labeled under G.C. Hanford, and
as follows: Penicillin G Procaine
under the following labels: IBA, The
Butler Company, Smith Kline Beecham
Animal Health, Lextron; Aquacillion
under the VEDCO label; Pen-Aqueous
under the following labels: Durvet,
RXV Veterinary Products, PVP,
Professional Vet Pharmaceutical;
(b) Penicillin G Benzathine and
Penicillin G Procaine in Aqueous
Suspension, labeled under G.C. Hanford
and as follows: Crystiben under the
Solvay Animal Health label;
Dura-Pen under the Durvet and VEDCO
labels;
Duo-Pen under the RXV Veterinary
Products and Vet Tek labels; Long
Acting Penicillin under the Premier
Farmtech label; Twin-Pen under the Agri
Laboratories label;
Benza-Pen under the SmithKline Beecham
label;
Sterile Penicillin G Benzathine and
Penicillin G Procaine under the Lextron
label; and Flo-Cillin - Fort Dodge
Laboratories. Recall #V-034/035-3.
CODE Lot numbers: (a) H3278, H3280, H3361,
H3369, H3436, H3420, H3421, H3423,
H3438, H3444, H3446, H3481, H3486,
H3488,H3489, H3490, H3491, H3499,
H3500, H3501, H3502, H3504, H3522,
H3578, H3580, H3604, H3613, H3614,
H3618, H3659, H3660, H3661, H3662,
H4340. Note: Some lots may have
letter A or H suffix;
(b) H3404, H3417, H3435, H3451, H3492,
H3493, H3523, H3527, H3556, H3581,
H3603, H3605, H3656, H3657, H3696,
H3726, H3753, H3754, 2E44504, 2K44506.
MANUFACTURER G.C. Hanford Manufacturing Company,
Syracuse, New York.
RECALLED BY Manufacturer, by letter May 28, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 479,524 vials; (b) 238,674 vials
were distributed; firm estimates less
than 10% of product remains on the
market.
REASON Lack of assurance of sterility.
_______________
PRODUCT Penicillin products: (a) Combiotic,
Penicillin and Dihydrostreptomycin in
aqueous suspension, in 250 ml bottles,
OTC for intramuscular administration;
(b) Pen BP-48, Penicillin G Benzathine
and Penicillin G Procaine, in Aqueous
Suspension, 100 ml and 250 ml bottles,
OTC for subcutaneous administration;
(c) PFI-Pen G, Procaine Penicillin G in
Aqueous Suspension, 100 ml, 250 ml and
500 ml bottles, OTC, for inamuscular
administration. Recall #V-036/038-3.
CODE Lot numbers: (a) L21210 & L21250;
(b) 100 ml vials lots L22110 & L22300
250 ml vials lots L21190, L21200,
L21390, L22090, L22100, L22450, L22460,
L22520, L22540, L22930, L23010, L23080,
L23140, & L30590;
(c) 100 ml vials lots L22160 & L22330;
250 ml vials lots L21980, L22020,
L22040, L22370, L22380, L22390, L22440,
L22530, L22550;
500 ml vials lots L21950, L22170,
L22240, L22250, L30060, & L30070.
MANUFACTURER Hoechst A.G. Frankfurt, Germany (bulk
penicillin);
Pfizer, Inc., Animal Health Division,
Lee's Summit, Missouri (finished
product).
RECALLED BY Pfizer, Inc., Lee's Summit, Missouri,
by letter May 28, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 885,098 units were distributed.
REASON Bulk penicillin distributed lacks
assurance of sterility.
MEDICAL DEVICE SAFETY ALERTS
=============================================
_______________
PRODUCT Valleylab E252H Disposable
Handswitching Argon Pencil with
disposable holster, a sterile,
disposable device used for
electrosurgery. Safety Alert #N-055-3.
CODE Catalog #E2522H, all lot manufactured
since October 1991.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
ALERTED BY Manufacturer, by letter June 7, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 1,463 cases (10 units per case) were
distributed; firm estimates 500 cases
remain on the market.
REASON Under certain conditions, argon gas
leakage may occur at the base of the
nozzle which may be ionized by the RF
current forming an unintended arc,
posing a burn hazard to the patient or
surgeon.
CRIMINAL INFORMATION:
====================================================
_______________
AGAINST Biopharmaceutics, Inc., Bellport, New York.
CHARGES Biopharmaceutics pleaded guilty to a three-count felony
Information. The Information charged the firm with
submitting false statements to the Food and Drug
Administration in applications seeking approval to market
various prescription drug products. The firm admitted that
in various applications submitted to the FDA in 1988 and
1989, it knowingly submitted false information relating to
its research and development in manufacturing three
different prescription drugs. The three drugs in question
were Clindamycin Hydrochloride 150 mg. capsules, an
antibiotic used in the treatment of serious infections;
Carisoprodol with Aspirin tablets, a muscle relaxant and
analgesic; and Chlorzoxazone 500 mg. tablets, a skeletal,
muscle relaxant. The other two counts to which
Biopharmaceutics pleaded guilty related to similar false
statements made in support of the firm's other
applications. Biopharmaceutics was sentenced to pay a
$350,000 criminal fine.
FILED July 8, 1993; U.S. District Court for the District of
Maryland; Criminal No. HAR-93-0274; FDC #66120.
SEIZURES:
================================================================
_______________
PRODUCT Various aquaculture drug products (993-652-883).
CHARGES New animal drug - There are no approved applications in
effect with respect to the uses or intended uses.
Misbranded - The articles' labels fail to bear adequate
directions for use in fish.
FIRM Argent Chemical Laboratories, Inc., Leland, Mississippi,
and Beardon Brothers Catfish Farm, Isola, Mississippi.
FILED June 22, 1993; U.S. District Court for the Northern
District of Mississippi; Civil #4:93CV179-S-0; FDC #66717.
SEIZED June 23, 1993 - goods valued at approximately $2,500 (at
Argent), and June 25, 1993 - goods valued at approximately
$32,500 (at Beardon).
_______________
PRODUCT Frozen shrimp (93-575-037/040).
Charge Adulterated - The article consists in whole or in part of
decomposed shrimp.
FIRM Christian Salvesen Cold Storage, Mobile, Alabama.
FILED June 23, 1993; U.S. District Court for the Southern
District of Alabama, Southern Division; Civil
#93-0530-CB-C; FDC #66734.
SEIZED June 25, 1993 - goods valued at approximately $70,000.
-10-
END OF ENFORCEMENT REPORT FOR JULY 21, 1993. BLANK PAGES MAY FOLLOW.
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