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
12/22/1993

Recalls and Field Corrections: Foods -- Class II -- 12/22/1993

December 22, 1993 93-51

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Oysters harvested at Cabbage Reef or Grand Pass, Louisiana:
(a) Shellstock Oysters packed in burlap sacks; (b) Shucked
Oysters in plastic tubs, 1 gallon. Recall #F-140/141-4.
CODE Shellstock is dated as to date of harvest on affixed oyster
tag. Shucked stock is dted as to date product shucked.
All product dated from 9-8-93 through 11-16-93.
SHIPPER/ Bayou Caddy Fisheries, Inc., Lakeshore, Mississippi,
RECALLER by telephone and fax November 19 or 20, 1993. Firm-
initiated recall complete.
DISTRIBUTION Virginia, Alabama, Mississippi, Texas, Florida, Louisiana,
Georgia.
QUANTITY 45,599 sacks shellstock oysters and 350 gallons shucked
oyststers were distributed; firm estimates none remains on
the market.
REASON The oysters harvested at Cabbage Reef and Grand Pass have
been associated with at least 16 discrete outbreaks of
gastroenteritis.

_______________
PRODUCT Shucked Oysters, in 8-ounce plastic containers harvested at
Cabbage Reef or Grand Pass, Louisiana. Recall #F-142-4.
CODE All products are coded "Sell By" date of December 2, 1993.
SHIPPER/ Carlo's Oyster, Inc., Amite, Louisiana, by telephone and
RECALLER letter November 24, 1993. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 300 cases (12 units per case) were shipped within a
commingled lot of 785 cases of oysters harvested from other
areas.
REASON The oysters harvested at Cabbage Reef and Grand Pass have
been associated with at least 16 discrete outbreaks of
gastroenteritis.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Slo-Phyllin, (Theophylline) 250 mg extended release
capsules, unit dose and in bottles of 100 and 1,000, used as
a bronchodilator. Recall #D-051-4.
CODE Product RPR lot Nos. EXP Geneva Lot Nos.
1000's 86575 5/94 70103
100's 91606 12/95 74151
Unit dose 91977 12/94 74151
MANUFACTURER Geneva Pharmaceuticals (formerly Cord), Broomfield,
Colorado.
RECALLED BY Rhone Poulenc Rorer, Inc., Collegeville, Pennsylvania, by
letter on or about December 12, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY 1,446 units of lot 86575; 1,350 units of lot 91977; 12,200
units of lot 91606 were distributed; firm estimates 72 units
of lot 86575; 610 units lot 91606; and 135 units of lot
91977 remain on the market.
REASON Product does not meet dissolution specifications.

_______________
PRODUCT Amoxicillin for Oral Suspension USP, 250 mg/5 ml, 150 ml
when mixed, Rx antibiotic. Recall #D-054-4.
CODE Lot #27718 EXP 8/1/95.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey.
RECALLED BY Manufacturer, by letter July 2, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION California, Louisiana, Oklahoma, Oregon, Pennsylvania, South
Carolina, Texas.
QUANTITY 6,540 bottles were distributed; firm estimates 300 bottles
remain on the market.
REASON Product does not meet potency specifications through
expiration date.

-2-_______________
PRODUCT Kaolin Pectin Suspension, an oral suspension, in 12 ounce
and 16 ounce bottles, used as anti-diarrheal treatment,
nonprescription. Recall #D-055-4.
CODE Lot #14770 EXP 6/95.
MANUFACTURER Ambix Laboratories, Division of Organics of America, East
Rutherford, New Jersey.
RECALLED BY Manufacturer, by telephone June 25, 1993, followed by letter
dated June 30, 1993. Firm-initiated recall complete.
DISTRIBUTION Michigan, New York.
QUANTITY FDA estimates none remains on the market.
REASON Microbiological contamination.

_______________
PRODUCT Isosorbide Tablets, 10 mg, solid dosage form, 100 tablets,
unit dose 10 x 10, Rx used for maintenance therapy for
angina pectoris. Recall #D-056-4.
CODE Lot #340A13.
MANUFACTURER Danbury Pharmacal, Inc., Danbury, Connecticut.
RECALLED BY Medirex, Inc., Pine Brook, New Jersey, by telephone May 19,
1993. Firm-initiated recall complete.
DISTRIBUTION New Jersey, New York, Virginia, Indiana.
QUANTITY 104 100-tablets units were distributed.
REASON Packages labeled as 10 mg contain 5 mg tablets.

_______________
PRODUCT Oral contraceptives:
(a) Loestrin Fe (Norethindrone Acetate and Ethinyl Estradiol
Tablet, USP and Ferrous Fumarate Tablets, USP), 1.5 mg/30
mcg, institutional package;
(b) Loestrin 21 (Norethindrone Acetate and Ethinyl Estradiol
Tablets, USP), package of 5 dispensers.
Recall #D-057/058-4.
CODE Lot numbers: (a) 035DFA EXP 11/95 (institutional package),
01502FA EXP 10/95 (package of 5 dispensers); (b) 01502FB EXP
10/95 (package of 5 dispensers), 035D2FD EXP 11/95 (package
of 5 dispensers).
MANUFACTURER Warner Lambert, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert, Morris Plains, New
Jersey, by letter dated September 28, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Lot 01502FA -- 6,226 units of 21's (pkg of 5); 18,218 units
of ferrous fumarate (pkg of 5); 100,760 cycles as 33,552
canadian units of physician samples.
Lot 035D2FA -- 23,177 units of 21s (pkg of 5), 1,122 units
of ferrour fumarate (inst. pkg 3 x 30 carton); 6,600 cycles
packaged as 1,315 Canadian units were distributed.
REASON Products may not meet content uniformity specifications.

-3-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Compazine Injection MDV (Prochlorperazine as the Edisylate
Injection), 10 ml vial/5 mg/ml, indicated for control of
severe nausea and vomiting, and for management of the
manifestations of psychotic disorders. Recall #D-052-4.
CODE 1-3C43 EXP 12/95.
MANUFACTURER Smithkline Beecham Pharmaceuticals Company, Cidra Puerto.
RECALLED BY Manufacturer, by letter December 6, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 15,336 vials were distributed.
REASON Product bears an extended expiration date of 12/96 instead
of 12/95.

_______________
PRODUCT Semicid Vaginal Contraceptive Inserts, a nonprescription
drug indicated for the prevention of pregnancy. Recall #D-
053-4.
CODE C324 EXP 3/95, C325 EXP 3/95 and C326 EXP9/95.
MANUFACTURER Whitehall Laboratories, Inc., Hammonton, New Jersey.
RECALLED BY Manufacturer, by letter July 1, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 14,000 dozen units were distributed.
REASON Superpotency.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Erbium-Doped Fiber Amplifier, Model 1702, used in
telecommunications. Recall #Z-100-4.
CODE No serial numbers.
MANUFACTURER AT&T Bell Laboratories, Murray Hill, New Jersey.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan November 20, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Maryland, New York.
QUANTITY 4 units.
REASON Noncompliance with performance standards for laser products
in that it did not incorporate a beam attenuator and display
all the required labels.

_______________
PRODUCT Davol Laparoscopic Suction Irrigation Probe, trumpet valve
probe with preattached 5 mm irrigation tip with side eyes.
Recall #Z-119-4.
CODE Reorder #0038300, lot #41JCST05.
MANUFACTURER Davol, Inc., Subsidiary of C.R. Bard, Inc., Cranston, Rhode
Island.

-4-RECALLED BY Manufacturer, by telephone June 4, 1993, followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,793 units were distributed.
REASON The laparoscopic probe is fitted with a handle which will
connect with an electrosurgical connector. End users
(doctors) believe the device is to be used during
electrosurgery, when in fact it is not intended for this
type of electrical connection.

_______________
PRODUCT Lens Holder Tray for Intraocular Lens:
Model No. GL55A distributed by DGR; Model No. SL550
distributed by Cirrus; Model No. PH550 distributed by
Acuity; Model No. U515A distributed by Isotech; and Model
No. P152A/ distributed by MDR;
Model No. GL55B distributed by DGR; Model No. SL550-2
distributed by Cirrus; Model No. PL55B distributed by
Acuity; Model No. U515B/ distributed by Isotech; Model No.
PL52B distributed by MDR;
Model No. GL65B distributed by DGR; GL650-2/ distributed by
Cirrus; PH650 distributed by Acuity; U615B/ distributed by
Isotech; PN55C distributed by MDR;
Model No. GL65C distributed by DGR; PN55C/ Distributed by
MDR;
Model No. PL52A distributed by DGR; PN148A/ distributed by
MDR;
Model No. PL52B distributed by DGR; PN148B/ distributed by
MDR. Recall #Z-123-4.
CODE The affected IOLS are the models above whose carton label
does not state a batch number or the batch number stated is
287 or below.
MANUFACTURER DGR, Inc., St. Petersburg, Florida.
RECALLED BY Manufacturer, by letter September 10, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, Louisiana, Georgia, Arizona, Michigan, Ohio,
Tennessee, Alabama, South Carolina, Iowa, Illinois.
QUANTITY FDA estimates little product remains on the market.
REASON Packaging design defect may subject the lens to damage when
lens is removed from the holder tray.

_______________
PRODUCT Vision Image Intensifiers (a) Model T3C-2; (b) Model T3C-3.
Recall #Z-127-4.
CODE None.
MANUFACTURER Novosibirsk Instrument Making Plant, Russian Federation.
RECALLED BY JNL Trading Company, Inc., New York, New York (importer).
FDA approved the firm's corrective action plan October 18,
1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 486 units.
-5-REASON The night vision equipment contained a radiation defect, in
that the products emitted x-radiation that is unnecessary to
the accomplishment of the purpose of the product, and
creates a risk of injury to users.

_______________
PRODUCT XLUHP-C Series Ultrasonic Handpiece, Part #52-0017-70, for
use with Model PHACO-XL, a phacoemulsification unit, to be
inserted into the eye to break up and aspirate a cataractous
lens, and also provides irrigation to maintain the anterior
chamber. Recall #Z-141-4.
CODE All serial numbers.
MANUFACTURER Zevex, Inc., Monrovia, California.
RECALLED BY Manufacturer, by letter September 30, 1993. Firm-initiated
recall complete.
DISTRIBUTION Arizona, California, Connecticut, Florida, Georgia, Indiana,
Minnesota, North Carolina, Nevada, Oklahoma, Utah.
QUANTITY 55 units were distributed.
REASON Device may cause electrical shock to patient or physician
while using instrument.

_______________
PRODUCT Retractable Laparoscope Electrodes Series E2787R and E2788R,
used in conjunction with Valleylab Disposable Pistol Grip
Laparoscopic Handsets for use in laparoscopic surgery.
Recall #Z-150/151-4.
CODE E2787R-28 (blunt) Lot numbers: 17191, 17839;
ER2788R-36 (sharp) lot #17806.
MANUFACTURER Valleylab, Inc., Pfizer Hospital Products Group, Boulder,
Colorado.
RECALLED BY Manufacturer by visit October 21, 1993, and by telephone
October 25, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nevada, Switzerland, Bolivia.
QUANTITY 7 units of lot #17191, 1 case (10 units per case) of lot
17,839, 1 case (10 units per case) of lot 17806.
REASON Devices are labeled as sterile, but the packaging enclosing
the electrodes may be perforated, thereby, compromising the
sterility.

_______________
PRODUCT Adult REM PolyHesive II Disposable Patient Return Electrode,
used in electrosurgery in conjunction with a generator to
return electrical current from the patient back to the
generator. Recall #Z-152-4.
CODE Catalog #E7507, lot #17913.

-6-MANUFACTURER Valleylab, Inc., Pfizer Hospital Products Group, Boulder,
Colorado.
RECALLED BY Manufacturer, by letter october 29, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Eastern coast of the United States.
QUANTITY 568 cases (50 units per case) were distributed.
REASON The packaging label reads Model E7507 while the electrode
contained within may be Model E5706. Improper use of this
electrode significantly increases the potential risk of a
burn to the user.

_______________
PRODUCT One Touch Foil-Wrapped Blood Glucose Test Strips, for use
with the One Touch or One Touch II Blood Glucose Meters.
(a) One Touch Foil Wrapped Test Strips (Consumer) 010-340,
010-368, 010-262; (b) One Touch Wrapped Test Strips
(Hospital) 010-342, 010-296; (c) One Touch II System 010-
270; (d) One Touch/One Touch II Patient Starter Kits 010-
299. Recall #Z-153/156-4.
CODE All lots.
MANUFACTURER Lifescan, Inc., A Johnson & Johnson Company, Cabo Rojo,
Puerto Rico.
RECALLED BY Manufacturer, by letter October 13, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 51.9 million test strips were distributed.
REASON The test strips may be exposed to moisture and may give
inaccurate low test results.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Diascan Strips, used in conjunction with the Home
Diagnostics Diascan Glucose Meter to determine Glucose
Levels in fresh whole blood:
(a) Product Code 150500 - 50 Strips per vial;
(b) Product Code 152000 - 25 strips per vial;
(c) Product Code 107500 - Diascan Starter Kit;
(d) Product Code 151000 - Accessory Kit.
Recall #Z-074/077-4.
CODE Lot numbers: M633735A EXP 5/31/93; 633735A EXP 5/31/93;
633738A,B,C EXP 6/30/93; 633746A EXP 8/31/93; 633804A EXP
6/30/93
MANUFACTURER Behringwerke Diagnostics, Division of Hoechst A.G., Marburg,
Germany.
RECALLED BY Home Diagnostics, Inc., Eatontown, New Jersey, by letter
March 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 268,015 units were distributed; firm estimates less than 1
percent of product remains on the market.

-7-REASON Devices could provide erroneously low glucose readings.

_______________
PRODUCT Urease + TDA (URTDA) for in-vitro diagnostic use only, in
bottles containing 50 tablets. Recall #Z-078-4.
CODE Product #R0115, Lot #57-52112 EXP 1/96.
MANUFACTURER Rosco Diagnostica, Taastrup, Denmark.
RECALLED BY Pro-Lab Diagnostic, Inc., Austin, Texas, by telephone
February 10, 1993. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 12 bottles were distributed; firm estimates none remains on
the market.
REASON Fourteen bottles of Urease, Lot 57-52112 was repacked and 10
bottles were mislabeled as Urease + TDA, Lot 57-52112.

_______________
PRODUCT Hybritech Icon Immunoconcentration Assay Kits,
(a) Strep A, Catalog Numbers: 4504 (48 test), 4509 (24 test)
in-vitro diagnostics for the detection and confirmation of
Group A Streptococcus antigen from throat swab;
(b) Strep B Catalog #4520 (24 test), for the detection of
Group B Streptococcus Antigen in urine from vaginal and
cervical swabs, and for the confirmation of Group B
Streptococci from blood agar culture. Recall #Z-097/098-4.
CODE Lot numbers: Catalog #4504 -- 292259, 292260, 292261,
292393, 292516, 292517, 390120 390122, 390138, 390172,
390273, 390274, 390275, 390276, 390677, 390481, 390493,
390494, 390495, 390600, 390672, 390673, 390695, 390858,
390859, 390993, 391210M;
Catalog #4509 -- 292381, 292382, 390030, 390072, 390319,
390320, 390321, 390497, 390498, 390592, 390733, 390772,
391075M, 391213M, 390041, 390042, 390048, 390091, 390092,
390139, 390140, 390141, 390142, 390143, 390288, 390289,
390437, 390438, 390457, 390468, 390477, 390618, 390619,
390732, 390799, 390800, 390861, 391062, 391063, 391064,
391065, 391211M;
Catalog #4520 -- 292381, 292382, 390030, 390072, 390319,
390320, 390321, 390497, 390498, 390592, 390733, 390772,
391075, 391213M. Lot numbers followed by "M" indicate kits
were packaged with global packaging.
MANUFACTURER Hybritech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter August 24, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Catalog #4504 -- 12,603 units distributed; firm estimates
2,000 remain on market; Catalog #4509 -- 25,770 units
distributed; firm estimates 4,000 remain on market; Catalog
#4520 -- 9,062 units distributed; firm estimates 1,300
remain on the market.

-8-REASON The wash reagent will change color from clear to purple
after prolonged exposure to light. Using the purple wash
will interfere with reading the test results.

_______________
PRODUCT Pregnancy Test hCG Urine Kit and Bulk:
(a) hCG Best Test, Catalog #BHF1001;
(b) hCG One Step, Catalog #BHF2201;
(c) hCG Optitec-Plus, Catalog #68355. Recall #Z-138/140-4.
CODE Nine lots of hCG urine tests are being recalled:
Lot # Exp Label
B10008 5/94 Kits - Optitec-Plus
B10007 5/94 Bulk - hCG
B10006 5/94 Bulk - Optitec-Plus
M16670 4/94 Bulk - BESTest
M16767 5/94 Bulk - hCG
M16583 3/94 Bulk - hCG
M16237 1/94 Bulk - hCG
M16236 1/94 Bulk - hCG
M16145 1/94 Bulk - hCG
MANUFACTURER Medix Biotech, Inc., Foster City, California.
RECALLED BY Manufacturer, by letter August 31, 1993 through September
15, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Spain Italy, Portugal, Israel, UK.
QUANTITY 114 kits (30 tests each); 36,930 test (bulk pouched tests)
were distributed; firm estimates less than 25 percent of the
product remains on the market.
REASON The loss of intensity observed in the test band could result
in a false negative interpretation.

_______________
PRODUCT HLA DR Select Tray, 72 wells per tray, used for human
lymphocyte antigen analysis for tissue typing, sold under
the Gentrak label. Recall #Z-142-4.
CODE Lot #S-3075, serial numbers 118-157 EXP 6/8/94.
MANUFACTURER Gen Trak, Inc., Plymouth Meeting, Pennsylvania.
RECALLED BY Manufacturer, by telephone August 19, 1993. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 4 boxes were distributed; firm estimates none remains on the
market.
REASON The trays were stamped backwards as a result of being
incorrectly loaded in a processing machine. The wrong
reagents were pipetted into the wrong wells of the tray.

_______________
PRODUCT 10/0 Ophthalmic Nylon Suture. Recall #Z-149-3.
CODE Product Code 1532-38, Lot numbers: 915766, 916729, 917796.
MANUFACTURER Davis & Geck, Inc., Division of American Cyanamid Company,
Manati, Puerto Rico.

-9-RECALLED BY Davis & Geck, Division of American Cyanamid Company,
Danbury, Connecticut, by letters of August 24 and 31, 1993.
Firm-initiated recall complete.
DISTRIBUTION New York, Illinois, Kansas, Indiana, New Jersey,
Pennsylvania, Argentina, Canada.
QUANTITY 201 boxes (12 dozen per box) were distributed.
REASON The outer box label incorrectly states that the product is
absorbable rather than nonabsorbable. The individual suture
packages are correctly labeled as nonabsorbable.

SEIZURES:
================================================================
_______________
UPDATE The seizure of Ear Candles, which appeared in the December
15, 1993 Enforcement Report was incomplete as reported.
This update is the complete text:

PRODUCT Ear candles, components, and brochures (93-671-958).
CHARGES Adulterated - The article is a class III medical device for
which no approved premarket approval application is in
effect; and, the methods used in, and the facilities and
controls used for, its manufacture, packing, and storage are
not in conformity with current good manufacturing practice.
Misbranded - The article's labeling represents and suggests
that it is adequate and effective for reducing ear wax,
fever, and infections associated with a ruptured ear drum,
and that it may be used as a replacement for surgical tubes
inserted in the ear, which representations and suggestions
are contrary to fact. The article's labeling fails to bear
adequate directions for use for the purposes for which it is
intended. The article is dangerous to health when used in
the manner recommended and suggested in the labeling. The
article was manufactured, prepared, propagated, compounded,
or processed in an establishment not duly registered and was
not included in a required list; a notice or other required
information was not provided as required prior to its
introduction into interstate commerce.
FIRM Quality Health Products, Fayette, Ohio.
FILED December 7, 1993; U.S. District Court for the Northern
District of Ohio, Western Division; Civ. #3:93CV7702;
FDC #66785.
SEIZED December 7, 1993 - goods valued at approximately $6,250.

-10-

END OF ENFORCEMENT REPORT FOR DECEMBER 22, 1993. BLANK PAGES MAY
FOLLOW.
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