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
06/19/1996

ENFORCEMENT REPORT FOR 06/19/1996

June 19, 1996 96-25

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Kellogg's Frosted Flakes Cereal, in 20 ounce
packages. Recall #F-569-6.
CODE Better if used before date of Feb 17 1997
NB011 printed on top of box.
MANUFACTURER Kellogg Company, Omaha, Nebraska.
RECALLED BY Kellogg Company, Battle Creek, Michigan, by
telephone on March 25, 1996. Firm-initiated
recall complete.
DISTRIBUTION Arizona, California, Nevada, New Mexico,
Oregon, Utah, Washington state.
QUANTITY Approximately 200 cases (12 boxes per case)
were distributed.
REASON The product contains pieces of another cereal
which contains undeclared milk products.

_______________
PRODUCT Canned Pitted Prunes, 24 ounces, under the
following labels: Dominick's California
Pitted Prunes and Meijer Dried California
Pitted Prunes. Recall #F-574-6.
CODE SEPT 1 96 V, NOV 1 96 V, DEC 1 96 V.
MANUFACTURER Valley View Yorkshire, Inc., San Jose,
California.
RECALLED BY Manufacturer, by letter on April 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois, Michigan, Ohio.
QUANTITY Dominick's: 696 cases (12 cans per case);
Meijer: 1,128 cases (12 cans per case) were
distributed.
REASON Cans are detinning resulting in high levels of
tin in the product.

_______________
PRODUCT Various Libby's brand juice products:
(a) Juicy Juice 100% Apple Juice
(b) Juicy Juice Strawberry
(c) Juicy Juice Cherry
(d) Juicy Juice Grape
(e) Juicy Juice Punch
(f) Juicy Juice Berry
(g) Juicy Juice Orange Punch
(h) Juicy Juice Apple Grape.
Recall #F-575/582-6.
CODE Libbys Juicy Juice 100% Apple Juice
(a) 8/46 ounce PET Bottles, codes 6008MT,
6013NA, 6015MT
(b) 12/46 ounce cans, codes 6006WF, 6009UN,
6015UN, 6015HN
(c) 44/4.23 ounce Flexible pack, codes
4-Sep-96, 5-Sep-96, 22-Oct-96, 23-Oct-96,
25-Oct-96, 30-Oct-96
Libbys Juicy Juice Strawberry
(a) 8/46 ounce PET Bottles, codes 6010,
14-Jun-16
(b) 44/4.23 ounce Tetra, codes 4-Aug-96,
6-Aug-96
(c) 12/46 ounce cans, codes 5355, 5356,5362,
5363, 6012
Libbys Juicy Juice Cherry
(a) 8/46 ounce PET Bottles, codes 6011,
6011FK, 6022
(b) 27/8.45 ounce Tetra, codes 3-Oct-96,
10-Oct-96, 16-Oct-96
(c) 44/4/23 ounce Tetra Pak, codes 11-Oct-96,
14-Oct-96, 15-Oct-96, 16-Oct-96, 17-Oct-96
Libbys Juicy Juice Grape
(a) 8/46 ounce PET Bottles, codes
6011,6022,5352FK, 6016
(b) 27/8.45 ounce Tetra, codes 5-Aug-96,
5-Oct-96, 6-Oct-96
(c) 12/46 ounce can, codes 5356, 6011
(d) 44/4.23 ounce Tetra, codes 11-Oct-96,
12-Oct-96, 13-Oct-96, 14-Oct-96, 2-Nov-96,
6033FK
Libbys Juicy Juice Punch
(a) 8/46 ounce/ PET Bottles, codes 6015,
6015FK, 6023, 6038

-2- (b) 44/4.23 ounce Tetra, codes 15-Oct-96,
16-Oct-96, 1-Nov-96,6023FK, 6032-33 FK
(c) 12/46 ounce can, codes 6018, 6032
(d) 27/8.45 ounce Tetra, codes
3-Oct-96,4-Oct-96, 15-Oct-96,6005FK
Libbys Juicy Juice Berry
(a) 8/46 ounce PET Bottles, codes 6015
(b) 12/46 ounce can, codes 53525361, 6004,
6018, 4-Oct-96, 11-Oct-96
(c) 27/8.45 ounce Tetra, codes 4-Oct-96,
5-Oct-96
Libbys Juicy Juice Orange Punch
(a) 27/8.45 ounce Tetra, codes 15-Oct-96
(b) 12/46 ounce can, code 5354, 5360,6005,
6032
Libbys Juicy Juice Apple Grape
(a) 12/46 ounce can, codes 5352, 5356, 6018
Libbys Juicy Juice Variety
(a) 27/8.45 ounce Tetra, codes 6010FK,
6-Sept-96, 7-Dec-96, 6005FK, 6018FK.
MANUFACTURER Nestle Beverage Company, San Francisco,
California.
RECALLED BY Manufacturer, by telephone, letter and press
release on February 13, 1996, by letter on
March 7, 1996, and by press release on March
8, 1996. Firm-initiated recall complete. See
also FDA talk paper T96-14, February 26, 1996.
DISTRIBUTION Nationwide.
QUANTITY 276,610 cases were distributed.
REASON Hydrolyzed inulin syrup has been substituted
in part for apple juice in these products.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
________________
PRODUCT Q&V brand Ginger Ale, in 12 fluid ounce
aluminum cans. Recall #F-583-6.
CODE 5354, 5277, 6010, 5334, followed with "CC" and
four additional numbers written beneath the
code.
MANUFACTURER Cotton Club Bottling Company, Cuyahoga
Heights, Ohio.
RECALLED BY Phar-Mor, Inc., Youngstown, Ohio, telephone on
April 18, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,187 cases (28,488 cans) were distributed.
REASON The product is adulterated due to the presence
of mold.

-3-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Actigall (Ursodiol) 300 mg Capsules, in
bottles of 100, Rx indicated for patients with
radiolucent, noncalcified gallbladder stones.
Recall #D-157-6.
CODE Lot numbers: 1350 EXP 3/97, 1355 EXP 5/97,
1365 EXP 6/97.
MANUFACTURER Giuliani S.p.A., Milan, Italy.
RECALLED BY Ciba-Geigy Corporation, Summit, New Jersey, by
letters dated March 11, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,160 bottles were distributed.
REASON Potential microbiological contamination.

_______________
PRODUCT Aspirin Free Excedrin Extra Strength Geltabs,
OTC drug, in 40 geltab bottles.
Recall #D-160-6.
CODE Lot numbers: 506015 and 506016 EXP 1/97.
MANUFACTURER Bristol Myers Products, Morrisville, North
Carolina.
RECALLED BY Manufacturer, by letter on May 8, 1996, and by
press release on May 9, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,243 cases (24 cartons per case) were
distributed.
REASON Several units of the recalled product were
found to contain No-Doz Caplets.

_______________
PRODUCT Lignospan Standard (Lidocaine Hydrochloride
and Epinephrine Injection, USP, 1:100,000),
packaged in 1.8 ml dental cartridges, a dental
anesthetic. Recall #D-161-6.
CODE Lot numbers: 2D4154 EXP 5/97, 2D4155
EXP 5/97.
MANUFACTURER Specialties Septodont, Saint Maur Des Fosses,
France.
RECALLED BY Septodent, Inc., New Castle, Delaware, by
telephone on May 21, 1996, followed by letter
dated May 23, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates minimal quantities remain on
the market.
REASON Subpotency of the epinephrine ingredient.

-4-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Rx bulk drugs: (a) Clobestasol Propionate, an
analog of prednisolone, a corticosteroid; (b)
Betamethasone Valerate, an anhydrous active
compound used to produce topical dermatologic
products; (c) Beclomethasone Dipropionate, an
anhydrous active compound used to produce
topical dermatologic products.
Recall #D-154/156-6.
CODE Lot numbers: (a) 5463/M1; (b) 5399/M1;
(c) 5375/M1.
MANUFACTURER Sicor, S.p.A., Rho, Italy.
RECALLED BY Vinchem, Inc., Chatham, New Jersey, by
telephone on December 19, 1995, and by
memorandum, December 20, 1995. Firm-initiated
recall complete.
DISTRIBUTION (a) Massachusetts; (b) Maryland, New York;
(c) California.
QUANTITY (a) 2 drums, each containing 1.0 kilogram; (b)
11 drums each containing 1 kilogram; (c) 1
container containing 500 grams were
distributed.
REASON Products contain trace quantities of
Decabromodiphenyl Ether resulting from
synthesis reagent.

_______________
PRODUCT Nardil (Phenelzine Sulfate Tablets, USP), 15
mg, in bottles of 100, Rx antidepressant.
Recall #D-158-6.
CODE Lot #07525D, N 0071-0270-24, EXP March 1997.
MANUFACTURER The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey.
RECALLED BY Manufacturer, by letter on March 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 19,428 bottles were distributed.
REASON Potency not assured through expiration date.

_______________
PRODUCT Choledyl (Oxtriphylline Delayed-released
Tablets, USP, 100 mg), in bottles of 100, Rx
bronchodilator. Recall #D-159-6.
CODE Lot #40571D, N 0071-0210-24, EXP 6/96.
MANUFACTURER The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey.
RECALLED BY Manufacturer, by letter on March 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 17,859 bottles were distributed; firm
estimates none remains on the market.
REASON Withdrawal of New Drug Application.
-5-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets, Pheresis. Recall #B-413-6.
CODE Unit #29133-4670.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated March 20, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON The product which did not meet the minimum
platelet count specifications was
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets;
(c) Recovered Plasma. Recall #B-427/429-6.
CODE Unit #8119190 and 8120843.
MANUFACTURER Permian Basin Regional Blood Center, Midland,
Texas.
RECALLED BY Manufacturer, by letter dated September 30,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas, Colorado.
QUANTITY 2 units of each component.
REASON Blood products, which were collected from a
donor with a medical history of yellow
jaundice, liver disease, hepatitis and
possible hepatitis exposure, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-433/434-6.
CODE Unit numbers: (a) 8120304, 8127512, 8127964;
(b) 8120304, 8127512.
MANUFACTURER Permian Basin Regional Blood Center, Midland,
Texas.
RECALLED BY Manufacturer, by letter dated September 30,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas, Colorado.
QUANTITY (a) 3 units; (b) 2 units.
REASON Blood products, which were collected from a
donor with a previous history of hepatitis,
were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-438/440-6.
CODE Unit #49F72492.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letters dated September 6 and
12, 1995, and October 5, 1995. Firm-initiated
recall complete.

-6-DISTRIBUTION Texas, California.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor taking
the drug Proscar, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-449/450-6.
CODE Unit #40GR42072.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letters dated October 2 and
4, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois, California.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially
reactive for HIV, units then tested into
compliance with several repeat tests performed
with no confirmatory test, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-456/457-6.
CODE Unit #40FK12086.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated October 5, 1995.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially
reactive for HIV, units then tested into
compliance with no confirmatory test, were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-458/459-6.
CODE Unit #40GV33402.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letters dated October 5 and
16, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois and New York.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially
reactive for HIV, units then tested into
compliance with no confirmatory test, were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-460/462-6.
CODE Unit #40GS43483.
MANUFACTURER American Red Cross, Peoria, Illinois.

-7-RECALLED BY Manufacturer, by letter dated October 3, 1995.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood product, which tested initially reactive
for HIV, units then tested into compliance
with no confirmatory test, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-465/466-6.
CODE Unit #40FF09758.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated September 22
and 27, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially
reactive for HBsAg, units then tested into
compliance with no confirmatory test, were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-463/464-6.
CODE Unit numbers: 40GR42697 and 40GS45574.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letters dated October 2 and
4, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units of each component.
REASON Blood products, which tested initially
reactive for HIV, units then tested into
compliance with no confirmatory test, were
distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-435-6.
CODE Unit numbers: 8120304, 8127512, 8127964.
MANUFACTURER Permian Basin Regional Blood Center, Midland,
Texas.
RECALLED BY Manufacturer, by letter dated September 30,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas, Colorado.
QUANTITY 3 units.
REASON Blood products, which were collected from a
donor with a previous history of hepatitis,
were distributed.

-8-_______________
PRODUCT Platelets. Recall #B-447-6.
CODE Unit #49P26358.
MANUFACTURER American Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letter dated October 6, 1995.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit.
REASON Blood product, mislabeled with the incorrect
expiration date was distributed.

_______________
PRODUCT Whole Blood. Recall #B-448-6.
CODE Unit #49Z26155.
MANUFACTURER American Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone on or about August
31, 1995, and by letter dated September 8,
1995. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, collected in expired collection
bag, was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Liquispex Urine Albumin Control, used on
Dupont ACA Clinical Analyzers, sold in Tri-
Level Kits:
(a) Tri-Level Set, Catalog #906; (b) Level 1,
Catalog #906-1; (c) Level 2, Catalog #906-2;
(d) Level 3, Catalog #906-3; (e) Sample Set,
Catalog No. None. Recall #Z-857/861-6.
CODE Lot numbers: (a) 5046; (b) 50461; (c) 50462;
(d) 50463; (e) 5046.
MANUFACTURER Clinical Controls, Inc., Grover Beach,
California.
RECALLED BY Manufacturer, by letter March 6, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Michigan,
Missouri, New York, Ohio.
QUANTITY 69 vials were distributed.
REASON The product is being marketed without an
approved premarket notification submission
(510(k)).

_______________
PRODUCT CodeMaster 100 Defibrillator/Monitor, Model
No. M2475B. The part of the device is the
Energy Select Switch, Part #3100-3705.
Recall #Z-871-6.
CODE Code Numbers: 3539A00483 through 3539A00669
(non-continuous).
-9-MANUFACTURER Hewlett-Packard Company, Andover,
Massachusetts.
RECALLED BY Hewlett-Packard Company, McMinnville, Oregon,
by field notification mailed on May 1, 1996,
followed by letter mailed on May 3 & 6, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 144 units were distributed.
REASON The energy select switches (Part No.
3100-3705) can develop a premature
intermittent problem, which may cause the
defibrillator/monitor to turn "OFF" even when
the rotary switch is in the "ON", or one of
the ENERGY SELECT positions.

_______________
PRODUCT Version 5A Software for CD Telemetry-Lan
System. System receives and analyzes ECG data
from bedside monitors. Recall #Z-872-6.
CODE All version 5A software on CD Telemetry-Lan
Systems.
MANUFACTURER Marquette Electronics, Inc., Milwaukee,
Wisconsin.
RECALLED BY Manufacturer, by letter on March 15, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 114 systems were distributed.
REASON The displayed and printed ST measurement
values may be inaccurate and ST warning alarms
cannot be relied on.

_______________
PRODUCT Angix Patient Tables, used for general
vascular angiography, angiography of the lower
limbs and angiocardiography procedures:
(a) Model No. 45475314 (MP9);
(b) Model No. 45475474 (MP7);
(c) Model No. 45475475 (MP7);
(d) Model No. 45553840 (MP8);
(e) Model No. 45553841 (MP8);
(f) Model No. 45554028 (MP9);
(g) Model No. 45554029 (MP9);
(h) Model No. 45561712 (MP10).
Recall #Z-883/890-6.
CODE All serial numbers.
MANUFACTURER G.E. Medical Systems, S.A., Buc Cedex, France.
RECALLED BY General Electric Company, Waukesha, Wisconsin,
by Field Modification Instructions issued on
March 9, 1995. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY 73 units were distributed. All units all have
been corrected.
-10-REASON A faulty speed control -12v power supply (Part
No. 45202947) can cause the table to move at
high speed whenever the enable button is
pressed, which can result in injury to the
patient.

_______________
PRODUCT Multiaxis Laser Cladding, CNC Machine Tools,
used as alignment of indexing parts on a work
station: (a) Model #HP-113CL; (b) Model
#HP115CL. Recall #Z-895/896-6.
CODE None.
MANUFACTURER S.E. Huffman Corporation, Clover, South
Carolina.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan March 25, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7 units.
REASON The laser products failed to comply with the
Federal laser product performance standard
protective housing requirements, 21 CFR
1040.10(f)(1) and labeling requirements, 21
CFR 1040.10(g)(5).

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Dade Immunoassay Controls, Tri-Level
Comprehensive, an in-vitro diagnostic used to
assist in monitoring accuracy and precision in
clinical assays:
(a) Dade Immunoassay Control, Tri-Level
Catalog Nos. B5700-05 and B5705-S
(b) Dade Immunoassay Control, Level 1, Catalog
No. B5700-06
(c) Dade Immunoassay Control, Level 2 Catalog
No. B5700-07
(d) Dade Immunoassay Control, Level 3 Catalog
No. B5700-08. Recall #Z-853/856-6.
CODE Lot numbers: (a) IACK-27; (b) IAC1-127;
(c) IAC2-227; (d) IAC3-327.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter sent on or about May
6, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,493 units were distributed.
REASON Multiple labeling errors were noted in the
package insert.

-11-_______________
PRODUCT 3F Embolectomy Catheter, Model RT-EMB-040-3F.
Recall #Z-862-6.
CODE Lot #95E043, Use before date 05/97,
Sterilization Date 5/95.
MANUFACTURER Applied Medical Resources, Laguna Hills,
California.
RECALLED BY Manufacturer, by letter mailed on August 31,
1995. Firm-initiated recall complete.
DISTRIBUTION Alabama, Arizona, Florida, Indiana, New
Mexico, New York, Pennsylvania, Texas,
Virginia, Washington state, Wisconsin, France.
QUANTITY 269 catheters were distributed; firm estimates
none remains on the market.
REASON The catheters are 80 cm in length, but are
mislabeled as being 40 cm in length.

-12-

END OF ENFORCEMENT REPORT FOR JUNE 19, 1996. BLANK PAGES MAY FOLLOW.

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