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
07/03/1996

ENFORCEMENT REPORT FOR 07/03/1996

July 3, 1996 96-27

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Breyers Blends with Hershey's Milk Chocolate
with Almonds Ice Cream, in pint containers.
Recall #F-611-6.
CODE Production Codes: BHO8296 / 1896C-1, 1896C-2,
1896C-3, Production Date 03/22/96, BHO8396 /
1896C-1, 1896C-2, 1896C-3, Production Date
03/23/96; BHO8996 / 1896C-1, 1896C-2, 1896C-3,
Production Date 03/29/96.
MANUFACTURER Good Humor/Breyers, Huntington, Indiana.
RECALLED BY Good-Humor/Breyers, Green Bay, Wisconsin, by
letter dated May 24, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 138,160 pints were distributed.
REASON The product contains undeclared peanuts.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Ice cream and yogurt products packaged in 0.5
gallon cartons:
(a) Butter Pecan Flavored ice cream
(b) Butter Pecan Low Fat ice cream
(c) Black Walnut Flavored ice cream
(d) Chocolate Chip Frozen Yogurt
(e) Praline Pecan Frozen Yogurt.
Recall #F-606/610-6.
CODE (a) Codes #100 & 106
(b) Code #106
(c) Code #106
(d) Code #107
(e) Code #107.
MANUFACTURER Mayfield Dairy Farms, Inc., Athens, Tennessee.
RECALLED BY Manufacturer, by telephone on May 3, 1996,
followed by letter dated June 5, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Georgia, South Carolina, Tennessee, Virginia.
QUANTITY 36,000 containers were distributed.
REASON The products are contaminated with ammonia.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
UPDATE Lemix brand Sweet and Sour Cocktail Mix,
Recall #F-561-6 which appeared in the June 12,
1996 Enforcement Report has been extended to
include the one-half gallon size bottles.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============
_______________
PRODUCT Albuterol Sulfate Inhalation Solution, 0.5%,
packaged in 0.25 ml and 0.5 ml unit dose
plastic tubes, Rx bronchodilator.
Recall #D-163-6.
CODE Lot numbers: 5M1 EXP 8/96, 5M2 EXP 9/96,
6C1 EXP 3/97.
MANUFACTURER Xactdose, Inc., South Beloit, Illinois
(repacker).
RECALLED BY Repacker, by telephone and letter on May 31,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,460 cases were distributed; firm estimated
that 5-10 percent of the product remained on
market at time of recall initiation.
REASON Presence of Pseudomonas putida in lot 5M1.
Lots 5M2 and 6C1 lack assurance that they are
not contaminated.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Chase Laboratories Nifedipine Capsules, USP,
10 mg, in bottles of 300 and 1,000 capsules,
Rx antianginal. Recall #D-165-6.
-2-CODE Lot number 210239 EXP 6/95.
MANUFACTURER Chase Laboratories, Inc., Newark, New Jersey.
RECALLED BY Manufacturer, by letter on February 16, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 847,000 units were distributed;
firm estimates none remains on the market.
REASON Product does not meet dissolution
specifications.

_______________
PRODUCT Duragesic 100 mcg/hr, (Fentanyl transdermal
system) boxes of 5, Rx narcotic analgesic.
Recall #D-168-6.
CODE Lot numbers 134524 and 134525.
MANUFACTURER Alza Corporation, Vacaville, California.
RECALLED BY Manufacturer, by letter on April 27, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 122,770 systems of lot 134524 and 116,625
systems of lot 134525 were distributed.
REASON A portion of the lots contain a packaging
defect which allows the system reservoir to
dry out, which may result in decrease rate of
delivery.

_______________
UPDATE Recall #D-137-6, CO2 Compressed Gas, which
appeared in the May 15, 1996 Enforcement
Report has been extended to include the
following lot numbers:
0140010596 0141010596
0141012496 0240011696
0241020696 0241021996
0340012396 0341022996
0440012696 0440020696
0441030596 0540021396
0540021596 0640021696
0740022396 0740022696
0840022896 0840030496.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Cefotetan Disodium (cefotan), 1 gm/100 ml per
vial, Rx antibiotic. Recall #D-164-6.
CODE 3024W EXP 1/98.
MANUFACTURER Smith Kline Beecham, Conshohocken,
Pennsylvania.

-3-RECALLED BY Zeneca Pharmaceuticals, Wilmington, Delaware,
by telephone on May 7, 1996. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 2 cases (40 vials per case) were distributed.
REASON Product exceeds specification for moisture
content.

_______________
PRODUCT Amantadine Hydrochloride Capsules, USP, 100
mg, in bottles of 500 and 100, Rx antiviral.
Recall #D-166-6.
CODE Lot #533649 EXP 6/96.
MANUFACTURER Chase Laboratories, Inc., Newark, New Jersey.
RECALLED BY Manufacturer, by letter on January 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 896,700 units were distributed;
firm estimates none remains on the market.
REASON Product does not meet content uniformity
specifications.

_______________
PRODUCT Bausch & Lomb Erythromycin Ophthalmic
Ointment, a sterile ophthalmic ointment, USP
0.5%, in 1 gram unit dose plastic tubes.
Recall #D-167-6.
CODE Lot #683431.
MANUFACTURER Bausch & Lomb Pharmaceutical Division, Tampa,
Florida.
RECALLED BY Manufacturer, by letter on June 3, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 68,000 tubes were distributed;
firm estimated that less than 200 units
remained on market at time of recall
initiation.
REASON Subpotency.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-444/445-6.
CODE Unit numbers: (a) 49G39719, 49F64623,
49LH08578, 49LF12140; (b) 49F64623, 49LF12140.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letters dated August 23,
1995, March 3 and 20, 1995, and February 23,
1995. Firm-initiated recall complete.

-4-DISTRIBUTION Texas, Oklahoma, California.
QUANTITY (a) 4 units; (b) 2 units.
REASON Blood products, collected from donors who
travelled to areas designated as endemic to
malaria, were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-453-6.
CODE Unit numbers: 29134-0760, 29134-0766, 29134-
0768, 29134-0769.
MANUFACTURER United Blood Service, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on March 26, 1996,
and by letter dated April 26, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 4 units.
REASON Blood product, which remained at room
temperature for an unknown length of time and
was incorrectly processed, was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Model U303000 TEC Guidewire, used for catheter
positioning. Recall #Z-901-6.
CODE Lot #F53058.
MANUFACTURER Interventional Technologies, Inc., San Diego,
California.
RECALLED BY Manufacturer, by letter April 13, 1996. Firm-
initiated recall complete.
DISTRIBUTION Ohio, Pennsylvania, West Virginia, Michigan,
Iowa, Missouri, Alabama, Georgia, California,
Oregon, Louisiana, Florida, Wisconsin,
Indiana, Kentucky, Illinois.
QUANTITY 131 units were distributed.
REASON The device's sterility may be compromised, due
to a defective pouch seal.

_______________
PRODUCT Collimator Carts for Multispect 2, Multispect
3, Diacam and BodyScan Gamma Camera Systems,
used to hold the collimators when they are
disconnected from the gamma detectors enabling
the cameras to fit in smaller rooms:
(a) Multispect 2; (b) Multispect 3;
(c) Diacam; (d) BodyScan. Recall #Z-904/907-6.
CODE All collimator carts with optional cart Gamma
Cameras shipped prior to 2/18/94.

-5-MANUFACTURER Siemens Medical Systems, Inc., Nuclear
Medicine Group, Hoffman Estates, Illinois.
RECALLED BY Manufacturer, by initiating a Mandatory
Immediate Field Modification Instruction
(FMI)-00120) on February 18, 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 71 carts were distributed; firm estimated that
66 units remained on market at time of recall
initiation.
REASON The set screws that secure the Collimator Cart
casters may come loose, which could cause the
casters to come off the cart.

_______________
PRODUCT Multispect 2 and Multispect 3 Gamma Camera
Systems, used in creating images from scans of
radioisotopes injected into the body:
(a) Multispect 2 Gamma Camera Systems;
(b) Multispect 3 Gamma Camera Systems;
(c) Diacam Gamma Camera Systems.
Recall #Z-912/914-6.
CODE All Analog and Integrated Diacam, Multispect 2
and Multispect 3 Gamma Camera System units
shipped prior to 9/30/94.
MANUFACTURER Siemens Medical Systems, Nuclear Medicine
Group, Hoffman Estates, Illinois.
RECALLED BY Manufacturer, by initiating a Mandatory Next
Service Call Field Modification Instruction on
December 23, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 280 units were distributed.
REASON The cameras prematurely terminate studies
during image acquisition.

_______________
PRODUCT Diagnostic X-Ray System (Image Intensifier
with an 80 rpm Mirror-Positioning Motor),
found in the following x-ray systems:
Hyperlux 22 3D-3C-V (Model No. C652937);
Hyperlux N22 3D-3C-V (Model No. C652753);
Hyperlux 30 3D-3C-V (Model No. C652998);
Hyperlux N30 3D-3C-V (Model No. C652726).
The 80 rpm mirror-positioning motor is also
found in image intensifiers with one of the
following positioners: Aromax (M, N, FM, or
FMA); Angiomax; Arcus Angiorama; Astar; Astar.
Recall #Z-923-6.

-6-CODE All of the Hyperlux devices, identified above,
with optical unit mirror-controlling motors
operating at 80 rpm on 220v or 24v.
MANUFACTURER GE Medical Systems S.A., Buc Cedex, France.
RECALLED BY General Electric Company, Medical Systems
Division, Waukesha, Wisconsin, by issuing
field modification instructions on August 25,
1995. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 54 units were distributed. All units have
been corrected.
REASON During a fluoroscopic procedure, the device
has the potential to lose image from its
monitor.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Glucometer Encore QA Plus Blood Glucose Meter
Model 5855. Recall #Z-897-6.
CODE Serial Nos. 1000003 through 1001090, and
1001091 through 1001931.
MANUFACTURER Bayer Corporation, Elkhart, Indiana.
RECALLED BY Manufacturer, by visit beginning on February
15, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,802 meters were distributed.
REASON A battery terminal and associated software
problem can produce a power interruption,
resulting in an erroneous display message.

_______________
PRODUCT ICON Software Version 5.2 used on the ICON A,
AP, and P Workstations and the Integrated
Gamma Camera Systems to conduct SPECT imaging
studies: Diacam; Orbiter; Multispect 2;
Multispect 3. Recall #Z-915/918-6.
CODE All units with ICON software version 5.2.
MANUFACTURER Siemens Medical Systems, Inc., Hoffman
Estates, Illinois.
RECALLED BY Manufacturer, by letter dated February 1995,
and publication #43, 53 301, and by initiating
a Mandatory Next Service Call Field
Modification Instruction (FMI-00152) on
February 28, 1995. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 340 units were distributed.

-7-REASON The integrated gamma camera systems displayed
truncation of the resultant SPECT
reconstruction images when an acquisition zoom
factor greater than 1.0 was used, and the
Three-View Display allowed only transverse
views, not oblique views, during the SPECT
processing.

_______________
PRODUCT AIMR Firmware Revision 3 Installed in the
Detector Heads of Integrated Gamma Camera
Systems: Diacam; Orbiter; Multispect 2;
Multispect 3. The camera systems are designed
for SPECT acquisitions/imaging studies.
Recall #Z-919/922-6.
CODE All ASIC based Integrated Diacam Integrated
Orbiter Multispect 2 and Multispect 3 Gamma
Camera System units shipped prior to 3/16/95.
MANUFACTURER Siemens Medical Systems, Inc., Hoffman
Estates, Illinois.
RECALLED BY Manufacturer, by initiating a Mandatory Next
Service Call Field Modification Instruction
(FMI-00158) on May 3, 1995. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 129 units were distributed.
REASON Static electrical discharge may occur during
collimator loading causing the device detector
to lose PMT Tune Data, which can introduce
cold spot areas in any image acquired.

_______________
PRODUCT HemoCard Hb S and Hb A&S Kits, in-vitro
diagnostic test kits for the detection of
hemoglobin variants:
(a) Code No. HC-1000; (b) Code No. HC-2000,
(c) Code No. HC-2030. Recall #Z-924/926-6.
CODE Lot numbers: (a) 604060; (b) 510082, 603022,
605002; (c) 604062, 605002.
MANUFACTURER Isolab, Inc., Akron, Ohio.
RECALLED BY Manufacturer, by letter on May 22, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Belgium, Israel,
Canada, France, England, Croatia.
QUANTITY 287 kits were distributed.
REASON The signal for Hb A & S and Hb S has weakened
and may produced a negative signal on a
positive control or patient sample prior to
the kit's expiration date.

-8-RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
=========
_______________
PRODUCT Nusal T Shampoo for Dogs, 6 ounce and 12 ounce
size, an antiseborrheic, antipuritic
therapeutic formulation. Recall #V-020-6.
CODE Lot #155070.
MANUFACTURER DVM Pharmaceutical, Miami, Florida.
RECALLED BY Manufacturer, by letter on March 29, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,112 6-ounce bottles and 504 12-ounce bottles
were distributed.
REASON Product was subpotent in one ingredient,
salicylic acid.

_______________
PRODUCT Isopropyl Alcohol, 70%, OTC use as a topical
antiseptic under the following labels: Chem-
Tronics, Inc., Phoenix Pharmaceutical, and
Animal health & Specialties (AHS).
Recall #V-021-6.
CODE Lot numbers: Chem-Tronics 10616856; Phoenix
30616806, AHS 80616816.
MANUFACTURER Chem-Tronics, Inc., Leavenworth, Kansas.
RECALLED BY Manufacturer, by letter dated April 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nebraska, Missouri, Arkansas.
QUANTITY 864 1-gallon containers were distributed.
REASON Product was outside of specification of
68-72%: Chem-Tronics -- subpotent to contain
60% isopropyl alcohol; Phoenix -- superpotent
to contain 76.2% isopropyl alcohol; AHS --
superpotent to contain 76.6% isopropyl
alcohol.

MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Sarns 6.5mm High Flow Aortic Arch Cannula with
Luer Lock Vent and Sarns 24 French Flexible
Aortic Arch Cannula with Luer Port
Product No. 98-0702-012403
(b) Product No. 98-0702-0024-5.
Safety Alert #N-020/021-6.
CODE Lot numbers: (a) A010496, A111495, A102796;
(b) A112795.
MANUFACTURER 3M Health Care, Ann Arbor, Michigan.
ALERTED BY Manufacturer, by letter May 22, 1996.
DISTRIBUTION Nationwide, Japan, Canada, Germany,
Netherlands, Croatia.

-9-QUANTITY 6,220 cannulas were distributed.
REASON Potential problem of blood leakage at the luer
connector with certain stopcocks, because of
mismatch in the taper between the stopcock
barrel and the luer port.

-10-

END OF ENFORCEMENT REPORT FOR JULY 3, 1996. BLANK PAGES MAY FOLLOW.

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