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 contain
s
information
on actions taken in connection with agency regulatory activities.
ENFORCE
10/01/1996
ENFORCEMENT REPORT FOR 10/02/96
October 2, 1996 96-40
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Murray Old Fashioned Ginger Snaps, in 1 pound
bags. Recall #F-736-6.
CODE 11275B2.
MANUFACTURER President's Baking Company, Augusta, Georgia.
RECALLED BY Manufacturer, by fax on July 5, 1995. Firm-
initiated recall complete.
DISTRIBUTION Georgia, South Carolina, North Carolina,
Kentucky, Indiana, Tennessee, Virginia, Maine,
West Virginia, Pennsylvania, New York,
Florida.
QUANTITY 1,496 cases were distributed; firm estimates
none remains on the market.
REASON Product contains undeclared peanuts.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============
_______________
PRODUCT Apothe'Cure DMSO (Dimethylsulfoxide) for
Injection, in 30 ml vials. Recall #D-270-6.
CODE Lots are coded by date of manufacture; the
following dates of manufacture are under
recall: April 1,3,10,12,18,26,30 1996; May
1,6,9,10,13-16 1996; June 3,4,7,13,20,26,28
1996; July 1,11,30 1996; August 2, 1996.
MANUFACTURER Apothe'Cure, Inc., Dallas, Texas.
RECALLED BY Manufacturer, by letter dated August 5, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON FDA analysis found samples contaminated with
bacteria; and FDA inspection uncovered
deficiencies of good manufacturing practices.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Altaire Pharmaceutical brand Clear Cough Cough
Suppressant Expectorant (Guaifenesin/
Dextromethorphan), Oral Liquid, in 4 fluid
ounce plastic bottles. Recall #D-271-6.
CODE Lot #60077 EXP 3/99.
MANUFACTURER Altaire Pharmaceutical, Inc., Holbrook, New
York.
RECALLED BY Manufacturer, by letter on August 22, 1996,
and by telephone on August 30, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Ohio, North Carolina,
Texas, Indiana, Wisconsin, Michigan, Alabama,
California, District of Columbia.
QUANTITY 12,316 units were distributed; firm estimated
that 200 units remained on market at time of
recall initiation.
REASON Product is misbranded because the dosing cup
does not bear measurements that are consistent
with the labeled dosing instructions.
_______________
PRODUCT Altaire Pharmaceuticals OTC pain relievers, in
4 fluid ounce plastic bottles: (a) APRA
Cherry-Flavored Children's Acetaminophen
Elixir; (b) Altenol Grape-Flavored Children's
Acetaminophen Elixir. Recall #D-273/274-6.
CODE Lot numbers and EXP dates:
(a) 50331 8/98
60001 1/98
60002 1/99
60031 1/99
60089 3/99
60096 3/99
60253 7/99
(b) 50477 12/97
50500 12/97
60041 2/98
60152 5/98
60210 5/98.
MANUFACTURER Altaire Pharmaceutical, Inc., Holbrook, New
York.
-2- RECALLED BY Manufacturer, by letter on August 22, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Alaska, Arizona, Arkansas, California,
Florida, Illinois, Indiana, Michigan,
Minnesota, New York, Texas, Puerto Rico.
QUANTITY (a) 67,945 units; (b) 23,012 units were
distributed; firm estimated that 12,000 units
combined remained on market at time of recall
initiation.
REASON Products are misbranded because the dosing cup
does not bear measurements that are consistent
with the labeled dosing instructions.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Tussilan Liquid, Rx, in 1 ounce, 4 ounce and
128 ounce containers, antitussive,
expectorant, nasal decongestant,
antihistamine, used in the treatment of colds.
Recall #D-272-6.
CODE Lot #181-5 EXP 8/97.
MANUFACTURER Sein Mendez Laboratories, Rio Piedras, Puerto
Rico.
RECALLED BY Manufacturer, by letter on August 14, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY 12,731 1-ounce units; 9,405 4-units; 172 units
were distributed.
REASON Product does not meet potency specifications.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT LifeStyles Condoms Lubricated with Nonoxynol-
9. Recall #Z-1202-6.
CODE Lot #311044100 EXP 11/96.
MANUFACTURER Ansell, Inc., Dothan, Alabama.
RECALLED BY Manufacturer, by telephone in April 1996.
Firm-initiated recall complete.
DISTRIBUTION California, Florida, Georgia, Massachusetts,
New Jersey, New York, Ohio, Oregon, Texas,
Vermont, Washington state.
QUANTITY Approximately 78,000 condoms were distributed;
firm estimates none remains on the market.
REASON The condoms failed the water leak test
apparently due to deterioration of the latex
because of improper storage conditions.
_______________
PRODUCT Hand Held Controllers used with Maxxus and
Optima Nuclear Medicine Imaging Systems, used
for patient imaging:
-3- (a) Model No. 46-324839P1 (Maxxus Hand Held
Controller);
(b) Model No. 46-324839P2 (Maxxus Hand Held
Controller);
(c) Model No. 46-324841P1 (Optima Hand Held
Controller);
(d) Model No. 46-324841P2 (Optima Hand Held
Controller);
(e) Model No. 2110099-2;
(f) Model No. 2112462-2.
Recall #Z-1228/1233-6.
CODE All serial number of installed Maxxus and
Optima systems.
MANUFACTURER IGE (International General Electric) Ltd., St.
Albans, United Kingdom.
RECALLED BY General Electric Company, Medical Systems
Division, Waukesha, Wisconsin, by issuing
field modification instructions on August 8,
1994, and by letter January 24, 1994. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 139 units were distributed.
REASON After the motion button is released, the
imaging system's table or detector head may
fail to stop.
_______________
PRODUCT Software version 4.8.19 used in Drake Willock
System 1000 Dialysis Delivery System, used in
hemodialysis treatment. Recall #Z-1234-6.
CODE Lot numbers: 5423, 7114, 7436, 7437,
7446-7490, and 7523-7835.
MANUFACTURER Althin Medical, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by telephone on august 5, 1996,
followed by letter on August 12, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Arizona, California, Connecticut, Florida,
Georgia, Indiana, Iowa, Maine, Massachusetts,
Missouri, New Jersey, New York, North
Carolina, Ohio, Tennessee, Texas, Washington
state, and international.
QUANTITY 437 units and 52 kits were distributed.
REASON The formaldehyde and actril chemical disinfect
modes may not function properly due to
software problems.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Sabratek Model 3030 Volumetric Infusion Pumps,
used in hospitals and home care for delivery
of intravenous fluids for inotropics,
antibiotics, TPN, IGG, Cytogram, pentamidine
and hydration therapies. Recall #Z-1110-6.
-4- CODE Serial numbers: 7000, 7002/7020, 7022,
7026/7030, 7047, 7077, 7079, 7086, 7248, 7277,
7278, 7279, 7303, 7310, 7346, 7356, 7357,
7362, 7364, 7387, 7395, 7405, 7410.
MANUFACTURER Sabratek Corporation, Niles, Illinois.
Eder Industries Inc., Oak Creek, Wisconsin
(printed circuit board).
RECALLED BY Sabratek Corporation, Niles, Illinois, by
telephone on August 2, 1995. Firm-initiated
recall complete.
DISTRIBUTION Ohio, Massachusetts, Illinois, California,
Florida, Texas, Pennsylvania.
QUANTITY 45 pumps were distributed.
REASON Two capacitors, C2 and C8, were misaligned
during assembly of the logic printed circuit
board, causing reversed polarity, which over a
period of time could cause capacitors to
initiate breakdown, resulting in a change in
the motor signal.
_______________
PRODUCT NewVues (vifilcon A) Soft Contact Lens,
hydrophilic contact lens. Recall #Z-1111-6.
CODE Lot #5348322.
MANUFACTURER Ciba Vision Corporation, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter August 16, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,648 multipacks (9,888 lenses) were
distributed.
REASON Lenses may contain a sphere power other than
that reflected in the labeling.
_______________
PRODUCT Lifepak 10 Defibrillator/monitor/pacemaker.
Recall #Z-1215-6.
CODE Serial numbers: 39808, 39809, 39810, 39811,
39813, 39814, 39816, 39818, 39820, 39821,
39823, 39829, and 39830.
MANUFACTURER Physio Control Corporation, Redmond,
Washington.
RECALLED BY Manufacturer, by visit beginning on August 7,
1996. Firm-initiated recall complete.
DISTRIBUTION Iowa, Massachusetts, North Carolina, New York,
Ohio, Pennsylvania, Rhode Island, Wisconsin.
QUANTITY 13 units were distributed.
REASON There was a potential for pacing function to
cease operation.
-5- _______________
PRODUCT Incstar CMV-vue Test Kit, Catalog #24300, for
the direct qualitative detection of early
structural protein of CMV (cytomegalovirus).
Recall #Z-1220-6.
CODE Lots 315676 and 315676A.
MANUFACTURER Incstar Corporation, Stillwater, Minnesota.
RECALLED BY Manufacturer, by letter on September 9, 1996.
Firm-initiated recall complete.
DISTRIBUTION Arkansas, Illinois, Maryland, New Mexico, New
York, North Carolina, Tennessee, Australia,
Germany, Italy, Korea, Portugal, Spain.
QUANTITY 67 kits were distributed.
REASON There was a decreased staining intensity in
the positive control. Because of this, low
positive samples have a potential to read
negative.
_______________
PRODUCT Vasoseal Vascular Hemostasis Device (VHD)
Kits, indicated for use in reducing time to
hemostasis at the femoral arterial puncture
side in patients who have undergone diagnostic
angiography or percutaneous transluminal
coronary angioplasty procedures using an 8
French or smaller procedural Sheath: Catalog
Numbers: 75301, 75302, 75303, 75304, 75305,
75306, 75307.
Recall #Z-1221/1227-6.
CODE 7 VasoSeal VHD Catalog Numbers:
75301 (Kit # 1 - Yellow)
75302 (Kit # 2 - Blue)
75303 (Kit # 3 - Red)
75304 (Kit # 4 - Green)
75305 (Kit # 5 - Purple)
75306 (Kit # 6 - Gray)
75307 (Kit # 7 - Orange)
Multiple VasoSeal VHD Lot Numbers: 06085171
through 09045171, inclusive, include products
involved included product shipment through 10
January 1996.
MANUFACTURER Bioplex Medical B.V., Vaas, The Netherlands.
RECALLED BY Datascope Corporation, Collagen Products
Division, Montvale, New Jersey, by letter sent
beginning February 20, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 5,970 kits were distributed.
REASON There may be a missing component in the kit.
-6- RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
=========
_______________
PRODUCT Custom Formula Medicated Swine Rations
containing Nutrena Profit Tract Feed IV and
Hygromix 8 (type A medicated article).
Recall #V-041-6.
CODE Custom Mix #9974 and Custom Mix #9990.
MANUFACTURER Cargill East Texas Feeds, Mineola, Texas.
RECALLED BY Cargill Inc., Giddings, Texas, May 10 and 11,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Texas.
QUANTITY 47,220 pounds of code 9974 and 47,340 pounds
of code 9990 were distributed.
REASON Product was superpotent in hygromycin B;
contained 10 times labeled level.
_______________
PRODUCT (a) Vitamin B12 Injection, 100-ml multi-dose
vials, a supplemental source in cattle, sheep
and swine, under the following labels: Sanofi
Animal Health, Inc., Vedco, Inc., and The
Butler Co.
(b) Oxytocin Injection, contain 20 USP units
oxytocin in 100-ml Multi-dose vials, for use
in inducing rhythmic contractions of the
smooth musculature of the uterus and/or milk
letdown in horses, cows, sows and ewes, under
the following labels: Sanofi Animal Health,
Inc., Vedco, Inc., Pro Labs, Ltd., and Aspen
Veterinary Resources, Ltd.
Recall #V-042/043-6.
CODE Lot numbers: (a) 51228 EXP 10/97;
51263 EXP 10/96.
MANUFACTURER Rhone Merieux, Inc., Fort Dodge, Iowa.
RECALLED BY Rhone Merieux, Inc., Athens, Georgia, by
letter on August 20, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION (a) Ohio, Missouri, Arizona, Alabama, Texas,
Colorado, California, Iowa, Florida, Kentucky,
Texas; (b) Missouri, Iowa, Alabama, Kansas,
Texas, Florida.
QUANTITY (a) 7,416 vials; (b) 41,700 vials were
distributed.
REASON Misalignment of the filling needles during the
filling process resulted in glass particles in
the vials. Particles ranged in size from 80-
200 microns.
-7-
END OF ENFORCEMENT REPORT FOR OCTOBER 2, 1996. BLANK PAGES MAY FOLLOW.
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