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
05/10/1995
ENFORCEMENT REPORT FOR 05 10 95
95-19
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT (a) Disopyramide Phosphate Capsules, USP, 100 mg, in bottles
of 100, Rx anti-arrhythmic under the following labels:
Biocraft, URL, Goldline, Qualitest;
(b) Nystatin Oral Suspension USP, 100,000 units/ml, in pint
containers, Rx for the treatment of oral candidiasis, under
the Biocraft and Goldline labels.
Recall #D-140/141-5.
CODE Lot numbers: (a) 20533 EXP 2/1/97; (b) 20834 EXP 1/1/96.
MANUFACTURER (3 satellite locations one or more applicable to each
product: Biocraft Laboratories, Paterson, New Jersey;
Biocraft Laboratories, Elmwood Park, New Jersey; Biocraft
Laboratories, Fairfield, New Jersey.
RECALLED BY Biocraft Laboratories, Inc., Fair Lawn, New Jersey, by
letter August 8, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 5,766 bottles were distributed; firm estimated that 10
percent of product remained on market at time of recall
initiation;
(b) 1,997 bottles were distributed; firm estimated that 10
percent of product remained on market at time of recall
initiation.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Nystatin Oral Suspension USP, 100,000 units per ml, in 60 ml
bottles, an antifungal antibiotic.
Recall #D-151-5.
CODE Lot #20662 EXP 11/1/95.
MANUFACTURER Biocraft Laboratories, Paterson, New Jersey.
RECALLED BY Biocraft Laboratories, Fair Lawn, New Jersey, by telephone
and by letter February 3, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 15,208 bottles were distributed.
REASON Possible microbiological contamination.
_______________
PRODUCT Medirex brand (a) Chlorpheniramine Maleate Tablets, 4 mg,
100 tablets in 10 10-unit dose blister packs, OTC
antihistamine; (b) Diphenhydramine Hydrochloride Capsules,
USP, 25 mg, 100 tablets in 10 10-unit dose blister packs, Rx
antihistamine. Recall #D-153/154-5.
CODE Lot numbers: (a) 118-014 EXP 7/96; (b) 321-054 EXP 7/96.
MANUFACTURER Medirex, Inc., Pine Brook, New Jersey (repacker/responsible
firm).
RECALLED BY Repacker, by letter November 2, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 420,000 tablets; (b) 457,000 capsules were distributed;
firm estimated that 329,500 tablets of Chlorpheniramine
Maleate and 393,200 capsules of Diphenhydramine
Hydrochloride remained on market at time of recall
initiation.
REASON Unit dose blister packages of Chlorpheniramine Tablets 4 mg
may be miscartoned as Diphenhydramine Capsules. Blister
packs are correctly labeled.
_______________
PRODUCT Aredia 60 ml vials Pamidronate Disodium for Injection for
intravenous infusion, Rx indicated for the treatment of
patients with moderate to severe Paget's disease of bone,
and also can be used for the treatment of moderate or severe
hypercalcemia associated with malignancy. Recall #D-156-5.
CODE Lot #1000200 EXP 3/96.
MANUFACTURER Ciba-Geigy Ltd., Basle Switzerland.
RECALLED BY Ciba-Geigy Pharmaceutical Division, Ciba-Geigy Corporation,
Summit, New Jersey, by letter February 3, 1995. Firm-
initiated real complete.
DISTRIBUTION Nationwide.
QUANTITY 1,726 vials were distributed.
REASON Some units do not declare the strength on the vial label.
_______________
PRODUCT Medical Oxygen (USP) in D size aluminum cylinders.
Recall #D-159-5.
CODE Serial numbers: D199446, D206758, D173073, D205326,
D206778, D214138, D203281, D192955, D193841, D205279,
D214385, D184197, D184460, D214423, D204208, D171601,
D191491, D194987, D214418, D202857, D190186, D195937,
D203236, D195259, D173044, D203708, D171661, D204370,
D205303, D173049, D195574, D195463, D184516, D195506,
D205328, D173046, D206828, D184488, D194957, D194967,
D203290, D203676, D203259, D199168, D214120, D202885,
D193841, D214429, D192931, D205322, D185083, D185157,
D214411, D173038, D173046, D214750, D173071, D207347,
D173050, D203380, D213944, D203280, D171535, D214413,
D192884, D193817, D195465, D184249, D199446, D202869,
D184470, D202849, D195268, D192915, D184535, D203284,
D199097, D195974, D194253, D195647, D194988, D173058,
D205289, D195529, D214415, D214414, D199461.
MANUFACTURER Health Training Educational Services, Inc., doing business
as Life Support Systems, Boston, Massachusetts
(repacker/responsible firm).
RECALLED BY Repacker, by letter and visit on or about April 20, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, New Hampshire, Connecticut.
QUANTITY 105 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Various drug products:
(a) Amiloride Hydrochloride and Hydrochlorothiazide Tablets
USP, 5 mg/50 mg, in bottles of 100, 500, and 1,000, Rx
diuretic under the following labels: Biocraft, Aligen,
Rugby, Geneva, H.L. Moore, Warner Chilcott, Harber, Mason,
Schein; (b) Amoxicillin for Oral Suspension USP,125 mg/5 ml
and 250 mg/5 ml, in 80 ml and 150 ml containers, Rx
antibiotic, under the Biocraft label;
(c) Amoxicillin Chewable Tablets USP, 250 mg, Rx antibiotic,
under the Biocraft label;
(d) Ampicillin for Oral Suspension USP, 125 mg/5 ml and 250
mg/5 ml, in 100 ml and 200 ml containers, Rx antibiotic,
under the following labels: Biocraft, Aligen, Major, Rugby,
Harber, Goldline, IDE Star, H.L. Moore, Qualitest, URL, and
Schein; (e) Cephalexin for Oral Suspension USP, 125 mg/5 ml
and 250/5 ml, in 100 ml and 200 ml containers, Rx single
ingredient cephalosporin, under the following labels:
Biocraft, Aligen, Biocef, Schein, Major, Rugby, Goldline,
Carlisle, Geneva, H.L. Moore, Qualitest;
(f) Sulfamethoxazole and Trimethoprim Tablets USP, 800
mg/160 mg, in bottles of 100 and 500, Rx antibacterial
tablet, under the Biocraft and Major labels.
Recall #D-142/150-5.
CODE Lot numbers: (a) All in-date lots; (b) 29000 EXP 11/01/95,
31212 EXP 12/01/96, 31337 EXP 02/01/97, 31340 EXP 02/01/97,
31954 EXP 08/01/97, 33343 EXP 12/01/97, 33351 EXP 12/01/97,
33674 EXP 03/01/98; (c) 33269; (d) All in-date lots;
(e) 52918 EXP 02/01/96, 52923 EXP 02/01/96; 52964 EXP
03/01/96, 53047 EXP 05/01/96; (f) 18030 EXP 02/01/96, 18104
EXP 03/01/96.
MANUFACTURER (3 satellite locations one or more applicable to each
product: Biocraft Laboratories, Paterson, New Jersey;
Biocraft Laboratories, Elmwood Park, New Jersey; Biocraft
Laboratories, Fairfield, New Jersey.
RECALLED BY Biocraft Laboratories, Fair Lawn, New Jersey, by letter
August 15, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Firm estimated that less than 10% of product remained on
market at time of recall initiation.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Stool Softener Plus Laxative Softgels, OTC useful in the
management of chronic or temporary constipation, under the
following labels: Arbor Drugs, 60 Softgels per bottle;
Discount Drug Mart, 100 Softgels per bottle; Osco, 100
softgels per bottles; Drug Emporium, 110 softgels per
bottles. Recall #D-152-5.
CODE Lot numbers and EXP dates: 139-1692 10/96, 139-1806 10/96,
139-2118 8/96, 139-2224 6/97.
MANUFACTURER Chase Laboratories, Inc., Newark, New Jersey.
RECALLED BY Guardian Drug Company, Trenton, New Jersey
(repacker/responsible firm), by letter March 30, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 273 cases of lot 139-1806, 171 cases of lot 139-1692, 44
cases of lot 139-2118, 248 cases of lot 139-2224 were
distributed.
REASON Leaking softgels.
_______________
PRODUCT Sulfamethoxazole and Trimethoprim double strength tablets,
Rx antibacterial, USP double strength, in bottles of 500,
under the URL and Biocraft labels. Recall #D-155-5.
CODE Lot numbers: 18485 EXP 9/1/95 (URL label only); 18806 EXP
1/1/97 (Biocraft label only).
MANUFACTURER Biocraft Laboratories, Inc., Paterson, New Jersey.
RECALLED BY Biocraft Laboratories, Inc., Fair Lawn, New Jersey, by
telephone on January 13, 1995, and February 3, 1995,
followed by letters of January 20, 1995 and February 3,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY 2,385 bottles were distributed; firm estimated that less
than 10% of product remained on market at time of recall
initiation.
REASON Product does not meet content uniformity specification for
the Trimethoprim ingredient.
_______________
PRODUCT (a) Mellaril Tablets (Sandoz brand name) / Thioridazine
Tablets (Creighton label) - Thioridazine HCL USP 200 mg
Tablets, packaged in 1000's and in 100's (unit dose packs),
Rx tranquilizer; (b) Cafergot Tablets - Ergotamine Tartrate
USP 1 mg, and Caffeine USP 100 mg Tablets, packaged in 90's
and 250's, Rx analgesic. Recall #D-157/158-5.
CODE All in-date product lots.
MANUFACTURER Sandoz Pharmaceuticals, East Hanover, New Jersey.
RECALLED BY (a) Sandoz Pharmaceuticals, East Hanover, New Jersey by
letters (fax) November 23, 1994, December 19, 1994, and
January 18, 1995; (b) Creighton Products, East Hanover, New
Jersey, by letter (fax) January 18, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide
QUANTITY Firm estimated that less than 10% of product remained on the
market at time of recall initiation.
REASON (a) Lack of assurance of dissolution specifications.
(b) Potential for subpotency.
_______________
UPDATE D-125-5,Ultra Strength Muscle Rub, which appeared in the
April 26, 1995 Enforcement Report is being updated to
include the following labels: Legend, Eckerd, Kinney, and
OSCO.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-307/308-5.
CODE Unit #29121-9302.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone December 21, 1994, followed by
letter December 28, 1994. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood products which were collected from a donor who had a
history of cancer were distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets; (d)
Recovered Plasma. Recall #B-310/313-5.
CODE Unit numbers: (a) 1073615, 4030907; (b) 4019164, 1067342,
5020196, 4040709, 2054407, C20312; (c) 4019164, 1067342,
5020196, 4040709, C20312; (d) 4019164, 1067342, 5020196,
4040709, 2054407.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letter May 12 or 13, 1994 (transfusable
products); Consignees of the Recovered Plasma and were
notified by letters dated January 16, 1995 and February 16,
1995. Firm-initiated recall complete.
DISTRIBUTION Kansas, Missouri, New York, Nebraska, Arizona.
QUANTITY (a) 2 units; (b) 6 units; (c) 5 units; (d) 5 units.
REASON Blood products, which tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT Source Plasma. Recall #B-314-5.
CODE Unit numbers: PG50847, PG51014, PG66678, XG79023.
MANUFACTURER Community Bio-Resources, Inc., Columbus, Georgia.
RECALLED BY Manufacturer, by letter August 11, 1994. Firm-initiated
recall complete.
DISTRIBUTION Austria.
QUANTITY 4 units.
REASON Blood products which were collected from donors with a
history of intravenous (IV) use were distributed.
_______________
PRODUCT Single Donor Plasma. Recall #B-315-5.
CODE Unit #53M36070.
MANUFACTURER American National Red Cross (ARC), The Greater Chesapeake
and Potomac Region, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter April 28, 1994, Firm-initiated
recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product, which tested positive for an alloantibody on
a screening test but was labeled as negative for unexpected
alloantibodies, was distributed.
_______________
UPDATE Please disregard and delete recall numbers B-234/235-5 from
the Enforcement Report dated April 26, 1995. These numbers
were issued in error to the respective Red Blood Cells and
Platelets. Red Blood Cells, unit 13FT60183 and Platelets,
unit 13FT60183, should have been assigned to recall numbers
B-237-5 and B-238-5, respectively which also appeared in the
April 26, 1995 Enforcement Report.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
______________
PRODUCT Dade Reverse-Cyte Reagent Red Blood Cells Groups A1, B and
Groups A1, A2, B. Recall #B-289-5.
CODE Catalog #B4953-1, lot RC-765 EXP 1/21/95, Catalog #B4953-2,
lot RCZ-765 EXP 1/21/95.
MANUFACTURER Baxter Diagnostics, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter December 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,501 kits were distributed; firm estimates none remains on
the market.
REASON Reagent Red Blood Cells, which were found to be hemolyzed,
were distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-234-5.
CODE Unit numbers: 03P69975 and 03P70004.
MANUFACTURER American National Red Cross (ARC), Atlanta, Georgia.
RECALLED BY Manufacturer, by letter April 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 2 units.
REASON Blood products which were not stored under continuous
agitation were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Roentgenography Sets, clear vinyl tubing with luer-lock
adapter, sterile single use flexible low pressure 20inch
(475 PSI) Tubing, Rx device used externally to aid in the
delivery of dyes to the body for x-ray analysis.
Recall #Z-697-5.
CODE Catalog #407286, lot #3D002 EXP 4/95.
MANUFACTURER Manufacturer, by telephone followed by letter November 23,
1993. Firm-initiated recall complete.
DISTRIBUTION California, Florida, Georgia, Illinois, Louisiana,
Massachusetts, Michigan, Minnesota, Nebraska, New Jersey,
New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia,
Wisconsin, West Virginia, and international.
QUANTITY 7,800 units were distributed; firm estimates none remains on
the market.
REASON Incorrect assembly of the device will result in leakage of
contrast media which may compromise product sterility.
_______________
PRODUCT Femoral Venous cannulae: (a) French size 17;
(b) French size 21. Recall #Z-718/719-5.
CODE Lot numbers: (a) 69311008 and 69401001; (b) 69306005,
69307003, 69310003, 69311002, 69305003, 69306004, 69307004,
69310001, 69311002, 69312008, 69309006, 69310004, 69311008,
69306005, 69306006, 69307004, 69307008, 69310007, 69310002,
69401008, 69307002, 69311005, 69307005, 69306005, 69306009,
69310003, 69310003, 69311008.
MANUFACTURER Adam Spence Corporation, Wall, New Jersey.
RECALLED BY DLP, Inc., Grand Rapids, Michigan, by letter February 18,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 964 units were distributed.
REASON The dilator does not traverse unrestricted through the
venous cannula.
_______________
PRODUCT CodeMaster XL+ Defibrillator/Monitor User's Guide:
(a) Model M1722A; (b) Model M1722B. Z-735/736-5.
CODE None.
MANUFACTURER Hewlett-Packard Corporation, McMinnville, Oregon.
RECALLED BY Manufacturer, by letter January 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON The firm had revised the "Troubleshooting the Pacer" section
of the User's Guide to include instructions to check the
electrode/pacing pads and pads adaptor cable connection,
reset the unit and restart the pacer. If the "PACER
FAILURE" MESSAGE reappears, the user is instructed to use a
back-up pacer and call for service.
_______________
PRODUCT Midmark Chick Ultralux Lo-Profile Birthing Room Lights,
Models 77000 and 77016. Recall #Z-738-5.
CODE Serial numbers ranging from TBS-1000 through TBS-1499.
MANUFACTURER Midmark Corporation, Versailles, Ohio.
RECALLED BY Manufacturer, by letter on or about February 10, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 500 units were distributed.
REASON The operation manual did not contain adequate directions for
the. The manual did not provide directions stating that the
user is not to undock the lighthead before the light reaches
its full stop, or fully open position.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Cardioplegia Cannula, Double Lumen 12 gauge, 3.25: length,
an aortic root cannula with vent line for injection
cardioplegia solution and/or aspirating air:
(a) Cardioplegia Cannula Product #30401;
(b) Cardioplegia Cannula Product #30402;
(c) Product #30401LK - Non-Sterile Cardioplegia Cannula
Double lumen, 50 per carton;
(d) Product #9900206 Customer Kit containing Cardioplegia
Cannula, Double Lumen, 1 per kit. Recall #Z-711/714-5.
CODE Lot numbers: (a) 6930-9006, 6930-8008; (b) 6931-0005, 6930-
8004; (c) 6931-0185, 6930-9138, 6930-8260.
MANUFACTURER Kendall Med-West, Salt Lake City, Utah (component).
RECALLED BY DLP, Inc., Grand Rapids, Michigan, by telephone December 2,
3, 6, 1993, followed by letter December 9, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 815 units; (b) 455 units; (c) 600 units; (d) 50 kits
were distributed.
REASON Leakage of the introducer needle at the hub or handle end
of the needle.
_______________
PRODUCT Baxter ImmunoSCAN Staph Latex Kit, used as an aid in the
identification of S. aureus colonies from laboratory culture
media. Recall #Z-715-5.
CODE Catalog #B1045-1A, lot #095K01 EXP 8/30/96.
MANUFACTURER Wampole Labs, Cranbury, New Jersey (kit); J&S Medical
Associates, Inc., Natick, Massachusetts (latex reagent).
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois, by
letter April 13, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 102 kits were distributed; firm estimated that 50% of
product remained on market at time of recall initiation.
REASON Autoagglutination of the latex may cause false positive test
results.
_______________
PRODUCT Act II (Automated Coagulation Timer II). Recall #Z-716-5.
CODE Lot numbers: 8001101, 8001102, 8001103, 8001104, 8001105,
8001106, 8001107, 8001108, 8001109, 8001110, 8001111,
8001112, 8001113, 8001114, 8001115, 8001116, 8001117,
8001118, 8001119, 8001120, 8001121, 8001122, 8001123,
8001124, 8001125, 8001126, 8001127, 8001128, 8001129,
8001130, 8001131, 8001132, 8001133, 8001137, 8001138,
8001139, 8001140, 8001142, 8001143, 8001146, 8001148,
8001152, 8001163, 8001181, 8001191, 8001001-8001010,
8001014, 8001016, 8001017, 8001022, 8001024, 8001030,
8001032, 8001039, 8001040, 8001051, 8001052, 8001055,
8001056, 8001057, 8001058, 8001059, 8001060, 8001061 -
8001077, 8001078, 8001091, 8001092, 8001093, 8001094,
8001095, 8001096, 8001097, 8001098, 8001099, 8001100.
MANUFACTURER Medtronic, Inc., Blood Management Division, Electromedics
and HemoTec, Parker, Colorado.
RECALLED BY Manufacturer, by letters January 27, 1995, and April 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Texas, Nebraska, Minnesota, West Virginia, Florida,
Iowa, Illinois, Georgia, Virginia, North Dakota, California,
New Jersey, international.
QUANTITY 250 units were distributed
REASON The door of the device may open following completion of the
test which may cause the display to clear and the unit to
reset.
-9-
END OF ENFORCEMENT REPORT FOR MAY 10, 1995. BLANK PAGES MAY FOLLOW.
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