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
06/14/1995

ENFORCEMENT REPORT FOR 06 14 95

June 14, 1995 95-24

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Morphine Sulfate Suppositories, 20 mg, Rx analgesic, in
boxes of 12. Recall #D-187-5.
CODE 5B680 and 4L619.
MANUFACTURER Paddock Laboratories, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter May 23, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,506 boxes were distributed.
REASON Potency is incorrectly declared as 10 mg on the back panel
of the carton. The principal panel and a side panel are
correctly labeled as 20 mg.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Sinucon Syrup, an OTC antihistamine/decongestant, under the
following labels: LuChem Pharmaceuticals/Sinucon Syrup, in
1 pint and 1 gallon bottles, Major Pharmaceuticals/Nalgest
Syrup, in 1 pint bottles. Recall #D-186-5.
CODE Lot #7986.
MANUFACTURER H.N. Norton Company, Shreveport, Louisiana. (Note: Firm
name change to Zenith Goldline Shreveport, Inc.)
RECALLED BY Manufacturer, by telephone and by letter April 12, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,463 1-pint bottles (LuChem label), 88 1-gallon bottles
(LuChem label), 712 1-pint bottles (Major label) were
distributed.
REASON Potential for crystal formation when product is exposed to
low temperatures.

_______________
PRODUCT Physostigmine Sulfate Ophthalmic Ointment (Eserine Sulfate
1/4%), 1/4 ounce, USP, in 1/8 ounce (3.5g) tubes, Rx
anticholinergic compound. Recall #D-188-5.
CODE Lot #2537 EXP 4/96.
MANUFACTURER Altana, Inc., Melville, New York.
RECALLED BY Manufacturer, by letter June 2, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,360 tubes were distributed.
REASON Potency not assured through expiration date.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-365/367-5.
CODE Unit #BUI 17033-9420.
MANUFACTURER Blood Systems, Inc., doing business as United Blood
Services, McAllen, Texas.
RECALLED BY Manufacturer, by letter January 16, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas, Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the antibody to
immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly for
anti-HIV-1, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, for further
manufacture; (c) Platelets; (d) Platelets, for further
manufacture; (e) Fresh Frozen Plasma; (f) Recovered Plasma.
Recall #B-369/374-5.
CODE All components manufactured from one unit of whole blood are
identified with the same unit number, date drawn and blood
type.
PRODUCT - Red Cells
UNIT NUMBER DATE DRAWN
32-01692 9/19/88
80-13522 12/13/88
80-49257 4/18/89
80-65054 6/23/89
80-76848 8/15/89
80-93517 11/27/89
81-07207 12/12/89

-2- 81-29213 4/17/90
81-32562 3/23/90
81-56337 6/22/90
81-68130 8/15/90
81-90159 12/7/90
81-93272 12/11/90
82-30275 4/30/91
82-42819 6/28/91
82-62865 9/20/91
83-58293 11/9/92
83-66304 12/7/92
83-70551 12/18/92
83-95722 4/26/93
84-11704 6/18/93
84-20663 8/5/93
84-21055 8/9/93
84-22774 9/9/93
84-35813 11/15/93
84-44998 11/8/93
84-47126 12/10/93
84-48827 12/9/93
84-54928 2/9/94
84-70094 3/11/94
PRODUCT - Platelets
UNIT NUMBER DATE DRAWN
80-02515 11/2/88
80-13522 12/13/88
80-49257 4/18/89
80-76848 8/15/89
81-07207 12/12/89
81-32562 3/23/90
81-56337 6/22/90
81-68130 8/15/90
81-90159 12/7/90
81-93272 12/11/90
82-30275 4/30/91
82-42819 6/28/91
82-62865 9/20/91
83-70551 12/18/92
83-95722 4/26/93
84-11704 6/18/93
84-20663 8/5/93
84-21055 8/9/93
84-35813 11/15/93
84-44998 11/8/93
84-47126 12/10/93
84-48827 12/9/93
84-54928 2/9/94
PRODUCT - Pooled Platelets
UNIT NUMBER DATE DRAWN
84-48827 12/9/93

-3- PRODUCT - Fresh Frozen Pooled
UNIT NUMBER DATE DRAWN
81-32562 3/23/90
81-56337 6/22/90
81-90159 12/7/90
82-30275 4/30/91
83-70551 12/18/92
84-22774 9/9/93
PRODUCT - Plasma
UNIT NUMBER DATE DRAWN
82-42819 6/28/91
82-62865 9/20/91
83-58293 11/9/92
83-66304 12/7/92
83-95722 4/26/93
84-11704 6/18/93
84-20663 8/5/93
84-21055 8/9/93
84-35813 11/15/93
84-44998 11/8/93
84-47126 12/10/93
84-48827 12/9/93
84-54928 2/9/94
84-70094 3/11/94
MANUFACTURER The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
RECALLED BY Manufacturer, by telephone, fax, and letter June 14, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Louisiana, New York, California, Florida, North Carolina.
QUANTITY 73 units.
REASON Blood products, which tested negative for hepatitis B
surface antigen (HBsAg), but were collected from donors who
previously tested repeatedly reactive for HBsAg, were
distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-381-5.
CODE Unit #26029-5282.
MANUFACTURER Blood Systems, Inc., doing business as United Blood Services
(UBS), Fort Smith Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by fax October 6,
1992. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product, associated with a unit of Red Blood Cells
which was contaminated with Propionibacterium acnes, was
distributed.

-4-_______________
PRODUCT Reagent Red Blood Cells RESOLVE(tm) Panel A.
Recall #B-382-5.
CODE KA810 EXP 7/26/94.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter July 18, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 648 packages.
REASON Reagent Red Blood Cell panels which contained errors on the
extended antigen profile, were distributed.

_______________
PRODUCT Reagent Red Blood Cells, RESOLVE(tm) Panel A.
Recall #B-383-5.
CODE Lot RA834 EXP 1/17/95.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by fax December 29, 1994, and by telephone
between February 27, 1995 and March 20, 1995, and by letters
of December 30, 1994 and March 23, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 802 packages.
REASON Lea positive Reagent Red Blood Cells, incorrectly labeled as
Lea negative, were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Transformer used with Ultrasonic Scaler used for cleaning
teeth, Model Turbo 25/30. Recall #Z-821-5.
CODE Serial numbers of Turbo Scaler #44867 - 45190. The
transformer does not have a serial number.
MANUFACTURER Woet Tsern Electronic Company, Ltd., Taipei, Taiwan
(contract manufacturer).
RECALLED BY Parkell Products, Inc., Farmingdale, New York, by telephone
August 12, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 326 units were distributed; firm estimates none remains on
market.
REASON The transformer was manufactured incorrectly which may lead
to lack of grounding which could cause the device to short
out.

_______________
PRODUCT Single Lumen Femoral Catheters under the Acuflex and Neostar
label. Recall #Z-822-5.
CODE Lot numbers: AT157, AT158, AT159, AT199, AT200, AT222,
AT223, AT225, AT245, AT246, AR260, AS197, AS198, AS244,
AS245, AS246, AS247, AS347, AT156.
MANUFACTURER Neostar Medical Technologies, Inc., King of Prussia,
Pennsylvania.

-5-RECALLED BY Manufacturer, by letter April 27, 1994 and May 3, 1994.
Firm-initiated recall complete.
DISTRIBUTION New York, West Virginia, Missouri, Colorado, England, Egypt,
India, Germany, Malaysia, Pakistan.
QUANTITY 6,089 units (kits and single catheters) were distributed;
firm estimates none remains on the market
REASON A 0.038" guidewire would not allow passage of the catheter's
tip.

_______________
PRODUCT Baxter Arterial and Venous Bloodlines:
(a) Baxter Arterial Blood Tubing Set for Hemodialysis,
Product Code 5M4253M;
(b) Baxter Arterial Blood Tubing Set for Hemodialysis with
Male Luer Rotating Lock, Product Code 5M4262M;
(c) Baxter Arterial Blood Tubing Set for Hemodialysis with
Male Luer Rotating Lock and Pressure Pillow Tubing, Product
Code 5M4283M;
(d) Baxter Venous Blood Tubing Set for Hemodialysis with two
lengths of tubing, Product Code 5M4491M;
(e) Baxter Venous Blood Tubing Set for Hemodialysis with
four lengths of tubing, Product Code 5M4484M.
Recall #Z-831/835-5.
CODE All lots.
MANUFACTURER Productos Urologos de Mexico S.A. de C.V., Mexicali-Baja,
Mexico.
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois, by
letter May 16, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Brazil, Venezuela.
QUANTITY 121,000 sets were distributed; firm estimated that 25
percent of product remained on market at time of recall
initiation.
REASON Blood tubing might not completely set in the dialyzer
connector resulting in a potential for blood leakage.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT 2991 Triple Processing Set, tubing set used in bone marrow
procedures. Recall #Z-779-5.
CODE Catalog #912647-901, Lot #07Z15125.
MANUFACTURER Cobe BCT, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer, by letter October 17, 1994. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts, Colorado, New York, Nebraska, Tennessee,
Texas, Belgium, France, Spain, England, Israel.
QUANTITY 216 units were distributed; firm estimates none remains on
the market.

-6-REASON A misassembly error resulted in the set containing an
incorrect tubing size than intended. The affected tubing is
used at the peristaltic set during a bone marrow procedure.
The failure to occlude the tubing results in the fluid being
unable to flow as directed by the pump which can result in
procedural inefficiency.

_______________
PRODUCT Preference 4-Pack, BC 8.7, DIA 14.4, Extended Wear Contact
Lenses. Recall #Z-828-5.
CODE L09483 (on outer carton).
MANUFACTURER Coopervision, Inc., Scottsville, New York.
RECALLED BY Manufacturer, by telephone April 7, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Arkansas, California, Florida, Georgia, Illinois,
Massachusetts, Missouri, North Carolina, New Jersey, New
York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas,
Wisconsin, West Virginia.
QUANTITY 23 4-packs were distributed. As of May 17, 1995 4 4-packs
remained unaccounted for.
REASON The lenses are labeled with the wrong power.

_______________
PRODUCT Cooperclear, BC 8.7, DIA 14.4, Daily Wear Contact Lenses,
sold in individual vials. Recall #Z-829-5.
CODE Lot #L09538.
MANUFACTURER Coopervision, Inc., Scottsville, New York.
RECALLED BY Manufacturer, by telephone April 21, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Arkansas, California, Florida, Georgia, Illinois,
Massachusetts, Missouri, North Carolina, New Jersey, New
York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas,
Wisconsin, West Virginia.
QUANTITY 26 lenses were distributed. As of May 9, 1995, 11 lenses
remained unaccounted for.
REASON The lenses are labeled with the wrong power.

_______________
PRODUCT Diamedix brand Anti-DNA Microassay, Catalog #783-200, 96
test set, for in-vitro diagnostic use. Recall #Z-836-5.
CODE Lot #S0404A EXP 8/95.
MANUFACTURER Diamedix Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter February 10, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 459 kits were distributed.
REASON Some of the wells in Anti-DNA Microassay, may not have been
coated with antigen during the manufacturing process.

-7-_______________
PRODUCT FIRST Choice Reagent Strips for use with Glucometer II
(GII), Glucometer II with Memory, and Glucometer M Blood
Glucose Meters: (a) Catalog No. 91050; (b) Catalog No.
91051; (c) FIRST Choice Reagent Strips for use with DIASCAN
Meter, Catalog No. 91080. Recall #Z-837/839-5.
CODE Lot Numbers: (a) F51445, F51446, F51447, F51449, F51450,
F51451; (b) F51450, F51451, F51454; (c) F70983.
MANUFACTURER Polymer Technology International (PTI), Issaquah,
Washington.
RECALLED BY Manufacturer, by letter March 5, 1995 and April 14, 1995,
followed by telephone the week of May 1, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Belgium, Taiwan, Poland, Japan, Pakistan,
Lebanon.
QUANTITY 103,327 packages were distributed.
REASON The blood glucose strips exceeded their specifications which
could provide inaccurate patient results.

-8-
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END OF ENFORCEMENT REPORT FOR JUNE 14, 1995. BLANK PAGES MAY FOLLOW.