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.

March 26, 1997 97-13

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Taigut Dried Potato, in 8 ounce flexible plastic bags.
Recall #F-272-7.
CODE None.
MANUFACTURER Sunwah Foodstuff Company, Kennedytown, Hong Kong.
RECALLED BY BCN Trading Corporation, Brooklyn, New York, by
letter dated June 14, 1996. Completed recall
resulted from sample analysis and followup by the
New York State Department of Agriculture and
Markets.
DISTRIBUTION New York, Massachusetts, Pennsylvania, New Jersey,
Florida, Connecticut, Illinois, District of
Columbia.
QUANTITY 284 cases (80 packages per case) were distributed; firm
estimates none remains on the market.
REASON Product contained undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Eagle Spice Rainbow Jimmies, in 3 ounce glass jars.
Recall #F-271-7.
CODE None.
MANUFACTURER Cocoline Chocolate Company, Inc., Brooklyn, New
York.
RECALLED BY Eagle Spice & Extract Company, Inc., Brooklyn, New
York (repacker/distributor), by telephone on
October 3, 1996, followed by visit. Completed
field correction (relabeling) resulted from visit
and followup by New York State Department of
Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY 98 cases (12 jars per case) were distributed.
REASON Product contains undeclared certified colors, FD&C Yellow
No. 5 & 6, Blue No. 1 & 2, and Red No. 3.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Cefaclor Capsules, USP (a) 250 mg; (b) 500 mg, in bottles
of 100, used for the treatment of the following
infections: otis media, lower and upper respiratory
infections, urinary tract infections, skin and skin
structure infections. Recall #D-130/131-7.
CODE Lot numbers: (a) 427568, 432237, 436212, 438681, 438913,
441703; (b) 430565, 432238.
MANUFACTURER UDL Laboratories, Inc., Rockford, Illinois.
RECALLED BY Manufacturer, by letter sent on March 4, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 8,830 unit cartons; (b) 1,252 unit cartons were
distributed; firm estimated that 20 percent of the 250 mg
product and 30 percent of the 500 mg product remained on
the market at time of recall initiation.
REASON Bulk Cefaclor was recalled by Roussel Corporation (parent
firm of Biochimica Opos, Italy due to AADA discrepancies:
AADA was withdrawn.

_______________
UPDATE Recall #D-091-7, Forest Pharmaceutials' (St. Louis, MO)
Rx Sus-Phrine, Epinephrine Injectable Suspension, 5
mg/ml, in 0.3 ml ampules, which appeared in the February
5, 1997, Enforcement Report has been extended to include
5 ml vials and the following lot numbers: 0.3 ml ampules
-- 94L410 EXP 11/97, 95A750 EXP 1/98; 5 ml vials --
95J680 EXP 7/97, 96E540 EXP 3/98.

-2-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Cimetidine HCl Injection, 300 mg/2ml, in 2 ml vials, used
in the treatment of ulcers, erosive gastroesophageal
reflux disease, and the treatment of pathological
hypersecretory condition. Recall #D-128-7.
CODE Lot #6699 EXP 9/98.
MANUFACTURER Luitpold Pharmaceutical, Inc., also known as
American Regent Laboratories, Inc., Shirley, New
York.
RECALLED BY Manufacturer, by fax and by mail on February 6,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 89,975 vials were distributed.
REASON Presence of precipitate.

_______________
PRODUCT Theomax DF Syrup (Ephedrine Sulfate, 6.25mg;
Theophylline, 32.5 mg, Hydroxyzine HCl, 2.5 mg), in one
pint bottles, for controlling bronchospastic disorders.
Recall #D-129-7.
CODE Lot numbers: RP3787 EXP 3/97, RB4122 EXP 7/97, VN4684 EXP
11/97.
MANUFACTURER Alpharma, also known as Barre-National, Inc.,
Baltimore, Maryland.
RECALLED BY Manufacturer, by letter on February 20, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,810 units were produced for Lot RP3787. 3,775 units
were produced for RB4122 and 3,677 units were produced
for VN4684. The firm estimates that there is no product
in commerce.
REASON Product fails content assay at the 24-month stability
timepoint (83%; SPEC is 90-112% of label strength).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-
467/468-7.
CODE Unit #10500-0138.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter
on January 3, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Arizona.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history
of hepatitis A.

-3-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-470/472-7.
CODE Unit numbers: (a) 20KG05708, 20GG72196, 20GG58325, 20GG32707,
20GG25431, 20GG19416, 20GG11712, 20G79144, 20G72467, 20G67870,
20G63587, 20G53254, 20G36753, 20G10348, 20G04116, 20G91891,
20G65952, 20G53017, 20G39639, 20G27479; (b) 20GG72196,
20GG58325, 20GG32707, 20GG25431, 20G72467, 20G53254, 20G91891;
(c) 20KG05708, 20GG72196, 20GG58325, 20GG32707, 20GG25431,
20GG19416, 20GG11712, 20GG03720, 20G79144, 20G72467, 20G67870,
20G63587, 20G53254, 20G36753, 20G27479, 20G10348, 20G04116,
20G91891, 20G65952, 20G53017, 20G39639.
MANUFACTURER American Red Cross Blood Services, Boise, Idaho.
RECALLED BY Manufacturer, by letters dated March 6, 21, 22, and
28, 1995. Firm-initiated recall complete.
DISTRIBUTION Idaho, Oregon, Washington state, California,
Tennessee, New York.
QUANTITY (a) 20 units; (b) 8 units; (c) 21 units were distributed.
REASON Blood products tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from a donor who previously tested
repeatedly reactive for anti-HIV-1.

_______________
PRODUCT Source Plasma. Recall #B-477-7.
CODE Unit #65210017.
MANUFACTURER Simi Biological Resources, Inc., Tacoma,
Washington.
RECALLED BY Manufacturer, by letter dated May 9, 1996. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products tested repeatedly reactive for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV).

_______________
PRODUCT Platelets. Recall #B-479-7.
CODE Unit numbers: 10229-8818, 10229-8817, 10229-8816, 10229-8815,
10229-8814.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter
on November 27, 1995. Firm-initiated recall
complete.

-4-DISTRIBUTION Arizona and South Dakota.
QUANTITY 5 units were distributed.
REASON Blood products were manufactured from whole blood that
was shipped at unacceptable temperatures.

_______________
PRODUCT Platelets. Recall #B-480-7.
CODE Unit numbers: 10230-1582, 10230-1583, 10230-1584, 10230-1585,
10230-1586, 10230-1588, 10230-1589, 10230-1591.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter
on November 22, 1995. Firm-initiated recall
complete.
DISTRIBUTION Arizona and South Dakota.
QUANTITY 8 units were distributed.
REASON Blood products were manufactured from whole blood that
was shipped at unacceptable temperatures.

_______________
PRODUCT Blood Bank Control System Software, BBCS Release Version
3.1 and 4.0.
Recall #B-484-7.
CODE Software version 3.1 and 4.0.
MANUFACTURER Blood Bank Computer Systems, Inc., Auburn,
Washington.
RECALLED BY Manufacturer, by letter on December 5, 1995. Firm-
initiated field correction complete.
DISTRIBUTION California, Florida, Illinois, Kansas, Texas,
Washington state.
QUANTITY 12 users which had the various versions installed.
REASON Computer software contained programming errors which
could have resulted in the release of unsuitable blood
products.

_______________
PRODUCT Red Blood Cells. Recall #B-485-7.
CODE Unit numbers: 18210-1913 and 18210-9308.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter
dated September 6, 1996. Firm-initiated recall
complete.
DISTRIBUTION Illinois and Wyoming.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who lived in
an area considered endemic for malaria.

-5-_______________
PRODUCT Red Blood Cells. Recall #B-486-7.
CODE Unit #49J67413.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letter dated December 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to
an area considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-488-7.
CODE Unit #FE19364.
MANUFACTURER Inova Blood Donor Services, Annandale, Virginia.
RECALLED BY Manufacturer, by letter dated February 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who emigrated
from an area considered endemic for malaria.

_______________
PRODUCT Platelets. Recall #B-490-7.
CODE Unit #11314-2743.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter
dated September 24, 1996. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood
which may have had an extended collection time.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-475-7.
CODE Unit #29137-6352.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on August 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood
designated as a difficult collection.

-6-_______________
PRODUCT Fresh Frozen Plasma. Recall #B-476-7.
CODE Unit #29137-2337.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on August 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood
designated as a difficult collection.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-481/483-7.
CODE Unit #KH59158.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on or about July 20,
1995. Firm-initiated recall complete.
DISTRIBUTION Virginia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose medical
history screening was inadequately performed.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-489-7.
CODE Unit #11314-5554.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on September 27, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood
with an extended expiration date.

_______________
PRODUCT Platelets. Recall #B-491-7.
CODE Unit #KP37831.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on December 21, 1995.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose health
history screening was inadequately performed.

-7-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=========
_______________
PRODUCT Valleylab Bipolar Footswitch, Model E6009, allows for
independent control of bipolar output with all Valleylab
Force series electrosurgical generators.
Recall #Z-321-7.
CODE Lot numbers M841470 and M841480.
MANUFACTURER Linemaster, Woodstock, Connecticut.
RECALLED BY Valleylab, Inc., Boulder, Colorado, by letter on
February 28, 1997, and by Federal Express during
week of March 3, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 178 units were distributed.
REASON The footswitch has the potential to self-activate, or
remain active (latch-on) after the pedal is released to
deactivate the generator output.

_______________
PRODUCT KAB System - CO2 Absorber, disposable, single use,
intended to be used during general anesthesia whenever
the clinician desires to have a self-contained breathing
system used versus the conventional semi-permanent CO2
absorber on the anesthesia gas machines.
Recall #Z-322-7.
CODE Catalog #KAB-001, lot numbers: 1042A7, 1535A7, 1854A7.
MANUFACTURER King Systems Corporation, Noblesville, Indiana.
RECALLED BY Manufacturer, by telephone on February 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION California, Indiana, Missouri, New York, Venezuela.
QUANTITY 120 cases of 10 units each were distributed.
REASON The potential exists that the Adjustable Pressure
Limiting valve could lodge in the closed position.

_______________
PRODUCT Medical Examination and/or Surgical Lights, ceiling
mounted models of both single and dual light design only:
(a) Centurion Brand, Model Nos. 021514, 021515, 721514,
721515;
(b) Centry Brand, Model Nos. 021314, 721314;
(c) Centura Brand, Model Nos. 022814, 022914, 722814;
Combination Models:

-8- (d) Centry & Centurion Brand, Model Nos. 020515, 720515;
(e) Centura & Centura Brand, Model No. 023015;
(f) Centry & Centura Brand, Model Nos. 028315, 029315;
(g) Centurion & Centura Brand, Model Nos. 028515, 029515,
728515, 729515.
Recall #Z-327/333-7.
CODE All units manufactured and distributed between 1/1/94 and
5/9/96.
MANUFACTURER Medical Illumination International, Inc., Arleta,
California.
RECALLED BY Manufacturer, by letter dated February 10, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 455 Centry Models, 977 Centurion Models, 69 Centura
Models, and 182 combination models were distributed.
REASON Products have retaining rings that may fail, causing the
light to fall.

_______________
PRODUCT Medtronic's Thera Implantable Pacemakers and Jewel
Arrhythmia management Device (ICD):
(a) Thera DR Pacemaker, Model Nos. 7940, 7941, 7942, 7950,
7951, 7952 (various serial numbers);
(b) Thera D Pacemaker, Model Nos. 7944, 7945, 7946 (various
serial numbers);
(c) Thera SR Pacemaker, Model Nos.8940, 8941, 8942 (various
serial numbers);
(d) Thera S Pacemaker, Model Nos. 8944, 8945, 8946 (various
serial numbers);
(e) Thera VDD Pacemaker, Model Nos. 8948 (various serial
numbers);
(f) Jewel Defibrillator, Model Nos. 7219B, C, D, E (various
serial numbers).
Recall #Z-334/339-7.
CODE Various serial numbers.
MANUFACTURERS Medtronic, Inc., Minneapolis, Minnesota; Medtronic
Med Rel, Inc., Humacao, RQ; Medtronic ESTC,
Kerkrade, The Netherlands.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by letter
dated February 18, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 177 Thera pacemakers and 4 Jewel defibrillators were
distributed.
REASON The controlling integrated circuit chips' manufacturing
defects (metal stress voiding), common to both devices,
can cause failure in any mode.

-9-_______________
PRODUCT MLT CO2 Surgical Laser, used in general surgery. Recall
#Z-340-7.
CODE Model MLT 20 Laser.
MANUFACTURER Medical Laser Technologies, Inc., Kennesaw,
Georgia.
RECALLED BY Manufacturer. FDA approved the firm's corrective
action plan on March 17, 1997. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 26 units were distributed.
REASON The device failed to comply with 21 CFR 1040.11(a)(2) in
that the operator's manual lacked calibration procedures
and certain required labeling.

_______________
PRODUCT Electrosurgical Probes used for soft tissue removal
indications in endoscopic surgical procedures:
(a) AccuLoop D4 Vaporizing Loop Electrode
(b) RollerLoop D4 Vaporizing Loop Electrode
(c) SingleBAR D4 Universal Rollerbar Electrode
(d) DoubleBAR D4 Universal Rollerbar Electrode. Recall #Z-
343/346-7.
CODE (a) Product Code AL24S,119650, 119646, 119651, 129613,
129620, 119624
(b) Product Code RL24W, Lot No. 089618;
Product Code RL24S, Lot No. 079658
(c) Product Code SB24S, Lot Nos. 109557, 109545, 119528;
Product Code SB24SS, Lot No. 109539; Product Code SB24C, Lot
Nos. 089519, 089504, 089511; Product Code SB24CC, Lot No.
109542
(d) Product Code DB24O. 109578, 109534; Product Code DB24S,
Lot No. 109530.
MANUFACTURER Ximed Medical Systems, doing business as Prosurg,
Inc., San Jose, California.
RECALLED BY Manufacturer, by fax and by letter on January 24,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,193 units were distributed.
REASON Validation for ETO reprocessing was not performed, and
functional testing was not established or performed after
ETO processing.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT CSI Clarity Contact Lenses:
(a) Daily Wear, Crofilcon Toric,
(b) Flexible Wear, Crofilcon Sphere.
Recall #Z-323/324-7.
-10-CODE Lot numbers: (a) CGGHX; (b) CGCPY.
MANUFACTURER PBH/Wesley Jessen (Barnes-Hind), San Diego,
California.
RECALLED BY Manufacturer, by telephone on November 30, 1996,
and by letter on or about January 31, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 80 lenses were distributed; firm estimated that 65 lenses
remained on market as of January 30, 1997.
REASON Some contact lenses were labeled with incorrect diopter
values that did not reflect the measured value of the
product.

_______________
PRODUCT CSI Clarity Contact Lens:
(a) Daily Wear Clear, Crofilcon Sphere, Lot CGZUH; (b) Daily
Wear, Crofilcon Toric, Lot CGXHZ. Recall #Z-325/326-7.
CODE Lot numbers: (a) CGZUH; (b) CGXHZ.
MANUFACTURER PBH/Wesley Jessen (Barnes-Hind), San Diego,
California.
RECALLED BY Manufacturer, by telephone on October 28, 1996, and
by letter on or about January 31, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, The United Kingdom, Japan.
QUANTITY (a) 314 lens were distributed; firm estimated that 142
remained on market as of January 30, 1997; (b) 44 lenses
were distributed; firm estimated that 13 remained on
market as of January 30, 1997.
REASON Some contact lenses were labeled with incorrect diopter
values that did not reflect the measured value of the
product.

_______________
PRODUCT Murex Salmonella O Polyvalent Groups A-S Agglutinating
Serum, 2 ml.
Recall #Z-341-7.
CODE Product #ZC02, Lot #K708610 EXP 5/28/97.
MANUFACTURER Murex Diagnostics Ltd., Dartford, England.
RECALLED BY Murex Diagnostics, Inc., Norcross, Georgia, by
telephone followed by letter dated September 12,
1996. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 2 vials were distributed.
REASON Serum does not detect the somatic O antigen of Salmonella
Group C1 (6,7-0) or Group G strains.

-11-_______________
PRODUCT BACTEC MYCO/FSPUTA Culture Vials Supplemented Middlebrook
7H9 Broth in 40 ml vials, Catalog Order No. 4402187, used
for the growth, support and detection of mycobacterium
from processed sputum and other respiratory specimens.
Recall #Z-342-7.
CODE Lot Numbers: 0015J, 0165K, 0305L, 0095N;
MANUFACTURER Becton Dickinson Microbiology Systems., Sparks,
Maryland.
RECALLED BY Manufacturer, by telephone and visit beginning on
March 1, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Singapore, Belgium, Brazil, Canada.
QUANTITY 49,900 vials were distributed; firm estimates none
remains on the market.
REASON The vials leaked.

-12-

END OF ENFORCEMENT REPORT FOR MARCH 26, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for