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.
February 19, 1997 97-08
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Neomycin (1.75 mg/ml) and Polymyxin B Sulfates
(10,000 units/ml) and Gramicidin (0.025 mg/ml,
Ophthalmic Solution, USP, Rx sterile, 10 ml,
under the following labels: Akorn - AK-SPOR,
Alba - ALBA-3 OPHTHALMIC SOLUTION, Carisle,
Geneva, Goldline, IDE-Interstate - TRIBIOTIC,
Rugby, Steris, URL, Aligen, Generics of Puerto
Rico - TRIPLE ANTIBIOTIC OPHTHALMIC, Major -
NEOCIDIN OPHTHALMIC SOLUTION, E. Fougera,
Schein. Recall #D-101-7.
CODE All lots within expiration date.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letter dated March 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Approximately 1,668,000 units of all lots were
distributed.
REASON Product lacks stability (i.e. Gramicidin fails
potency assay at 18-month stability timepoint
-- 80%; SPEC is 90-110%).
_______________
PRODUCT B-C-12-1000 (B Complex with C and B12),
Lyophilized), for Injection, in 10 ml
multidose vials, under the following labels:
Carlisle, Clint Pharmaceuticals, Inc. -
"VITA-PLEX", Germiphene, Gil Pharmaceutical -
"VITAJECT", Goldline, Hyrex - "KEY-PLEX
UNIVIAL", IDE - Interstate, International
Ethical Lab - "NEUROFORTE-SIX", Jaapharm
Canada Inc., Keene Pharmaceuticals - "VICAM
(IV)", Key Co., Lambda Pharmacal - "NEURO B12
FORTE", Llorens Pharm Corp., McGuff Co.,
Medical Products Panamericana - "NEURODEP",
Merit, Moore, OTC Pharmaceutical Products -
"NEUROBION", R.W. Enterprise (USA), Rugby,
Schein, Seyer - "SUPERVITE", Sorter - "NEURIN
- BC", Steris, United Research Labs.
Recall #D-102-7.
CODE All lots within expiration date.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letters dated April 17, 1996,
and June 13, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Japan.
QUANTITY Approximately 388,000 units were distributed.
REASON Product lacks stability (i.e., Dexpanthenol
fails potency assay as early as the 12-month
stability timepoint -- 89%; SPEC is 90-110%).
_______________
PRODUCT Morphine Sulfate Injection, Rx, USP, (a) 1
mg/ml and (b) 0.5 mg/ml, in 10 ml single dose
vials. Recall #D-103/104-7.
CODE Lot numbers: (a) 94K200, 94M050, 95E380,
95H610; (b) 94L120, 94L700, 95A010.
MANUFACTURER Steris Laboratories, Inc, Phoenix, Arizona.
RECALLED BY Manufacturer, by letter dated April 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) Approximately 36,000 vials; (b)
Approximately 53,000 vials were distributed.
REASON Presence of particulate matter.
_______________
PRODUCT Chorionic Gonadotropin for Injection, Rx, USP,
10,000 units/10 ml multiple dose vial,
distributed under the following labels:
Steris, Schein, Carlisle, Goldline, Hyrex -
Chorex-10, R.W. Enterprises (USA) - Ovulatone.
Recall #D-105-7.
CODE All product within expiration date.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
-2-RECALLED BY Manufacturer, by letter dated May 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 147,000 vials were distributed.
REASON presence of particulate matter.
_______________
PRODUCT Multivitamins for Infusion, Rx, in 10 ml
single dose vials, under the following labels:
Schein, Steris, Faulding (Canada).
Recall #D-106-7.
CODE All lots within expiration date.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letter dated April 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 3 million vials were
distributed.
REASON Presence of particulate matter.
_______________
PRODUCT Heparin Sodium Injection, USP, Rx, used for
used for anti-coagulant prophylaxis and
treatment, under the following labels -
Steris, Schein, Biogen:
(a) 1,000 units/ml in 10 ml vials;
(b) 20,000 units/ml, in 1 ml and 2 ml vials;
(c) 40,000 units/ml, in 1 ml, 2 ml, and 5 ml
vials. Recall #D-107/109-7.
CODE Lot numbers: (a) 95F780; (b) 96C390 (1 ml),
94E850, 95D740, 95F910 (2 ml); (c) 95K080 (1
ml), 95B190 (2 ml), 95A040, 95B191, 95K081,
95A040 (5 ml).
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letter dated November 4,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Ukraine.
QUANTITY Approximately 34,000 vials of all sizes were
distributed.
REASON Presence of particulate matter.
_______________
PRODUCT Prochlorperazine Edisylate Injection, USP, 10
mg/2 ml, Rx, used for used for the treatment
of severe nausea and vomiting, and for the
management of the manifestations of psychotic
disorders. Recall #D-110-7.
CODE Lot numbers: 94F910, 94G570, 94H280, 94H320,
94J400 (All lots within expiration date).
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letters dated January 18,
1996, and February 8, 1996. Firm-initiated
recall complete.
-3-DISTRIBUTION Nationwide.
QUANTITY Approximately 18,500 vials were distributed.
REASON Product lacks stability (fails potency assay
at the end of expiry).
_______________
PRODUCT GoJo brand Hand Medic Antiseptic Skin
Treatment, OTC, in 500 ml cartridges.
Recall #D-111-7.
CODE Batch numbers: 049671, 049672, 049673,
049674.
MANUFACTURER Gojo Industries, Inc., Cuyahoga Falls, Ohio.
RECALLED BY Manufacturer, by fax sent on January 28-30,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide (to industrial users only).
QUANTITY The following amounts of product identified
with the referenced stock numbers were
distributed: Stock No. 8242-512-R1: 8,184
cartridges; Stock No. 1302-01: 5,760 cases;
and Stock No. 8242-06: 220 cases.
REASON Subpotent -- Recalled lots do not contain the
sole active ingredient, benzalkonium chloride.
_______________
PRODUCT Martec brand Piroxicam Capsules, USP, 10 mg,
in bottles of 100, Rx indicated for use in
arthritis. Recall #D-112-7.
CODE 96556-1 EXP 03/01.
MANUFACTURER Martec Pharmaceutical, Inc., Kansas City,
Missouri.
RECALLED BY Manufacturer, by letter dated January 24,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,347 bottles were distributed between
7/11/97 - 1/23/97.
REASON Unit label may lack the prescription legend;
insert is correctly labeled.
_______________
PRODUCT Ethex brand Hydrocodone Bitartrate and
Guaifenesin Liquid, in 16 fluid ounce bottles,
Rx for the temporary relief of dry,
nonproductive cough associated with upper and
lower respiratory tract congestion.
Recall #D-116-7.
CODE Lot numbers: L8693 and L8696.
MANUFACTURER KV Pharmaceutical Company, St. Louis,
Missouri.
RECALLED BY Ethex Corporation, St. Louis, Missouri, by
letter dated January 24, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
-4-QUANTITY 14,136 bottles of lot L8693 were distributed
between 12/23-30/96 and 7,307 bottles of lot
L8696 were distributed between January 13-16,
1997.
REASON Presence of precipitate (guaifenesin is
precipitating due to exposure to low
temperatures while warehoused and shipped.
_______________
PRODUCT Alcoholado Alcanformentol 70, OTC alcohol 70%
(topical liquid), in 12 fluid ounce bottles.
Recall #D-117-7.
CODE Lot #G07-0794 EXP 11/27/99.
MANUFACTURER Specialties Chemical, Inc., Ponce Puerto Rico.
RECALLED BY Manufacturer, by visit on January 27, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY 192 bottles were distributed.
REASON Incorrect product formulation -- isopropyl
alcohol used instead of ethyl alcohol.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-344/345-7.
CODE Unit #8145560.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on November 20,
1996. Firm-initiated recall complete.
DISTRIBUTION Texas and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
had been permanently deferred.
_______________
PRODUCT Recovered Plasma. Recall #B-349-7.
CODE Unit #355079.
MANUFACTURER Memorial Blood Centers of Minnesota,
Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter dated November 1,
1995. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported an accidental needlestick within 12
months of donation.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma; (e)
Platelets, for further manufacture.
Recall #B-353/357-7.
-5-CODE Unit numbers: (a) 8107974, 8109809, 8116534,
8116938, 8118637, 8120204, 8122411, 8120323,
8125739, 8128055; (b) 8107974, 8116938,
8118637, 8120204, 8120323; (c) 8106846; (d)
8107974, 8109809, 8116534, 8116938, 8118637,
8120204, 8122411, 8120323, 8125739, 8128055;
(e) 8122411, 8125739.
MANUFACTURER Permian Basin Regional Blood Center, also
known as Permian Basin Blood Institute,
Midland, Texas.
RECALLED BY Manufacturer, by letter dated September 30,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas, Colorado.
QUANTITY (a) 10 units; (b) 5 units; (c) 1 unit; (d) 10
units; (e) 2 units were distributed.
REASON Blood products tested negative for HBsAg were
collected from donors who reported histories
of jaundice, liver disease, or hepatitis, or
were subsequently collected from these donors.
_______________
PRODUCT Red Blood Cells. Recall #B-372-7.
CODE Unit numbers: 49J66132, 49J66819.
MANUFACTURER American National Red Cross, Norman, Oklahoma.
RECALLED BY Manufacturer, by letter dated June 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION California and Oklahoma.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.
_______________
PRODUCT Source Plasma. Recall #B-373-7.
CODE FP57388, FP57333, FP57233, FP57188, FP57041,
FP56981, FP56952, FP56897, FP56851, FP56809,
FP56752, FP58712, FP56674, FP56621, FP56589,
FP56522, FP56489, FP54195, FP53959, FP53817,
FP53629, FP53590, FP53514, FP53474, FP53353,
FP53291, FP53181, FP53125, FP52926, FP51289,
FP51784, FP51584, FP51182, 52459788, 52458088,
52454943, 52450839, 52438585, 52436956,
52435447, 52433634, 52431913, 52417740,
52415908, 52413667, 52412158, 52099120,
52097645, 52095504, 52094231, 52091230,
49809695, 49806854, 49805280, 49802788,
49801682, 49469509, 49467857, 49464979,
47485167, 47482593, and 47480773.
MANUFACTURER Interstate Blood Bank, Inc., of WI, Milwaukee,
Wisconsin.
-6-RECALLED BY Interstate Blood Bank, Inc., Memphis,
Tennessee, by telephone on February 15, 1996,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION California and Germany.
QUANTITY 62 units were distributed.
REASON Blood products tested negative for the
antibody to the hepatitis C virus encoded
antigen (anti-HCV), were collected from a
donor who had previously tested repeatedly
reactive for anti-HCV.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-374/375-7.
CODE Unit #2838997.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter dated July 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
traveled to a malarial endemic area.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-378/380-7.
CODE Unit #2850080.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter July 26, 1996. Firm-
initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
received ear piercing within twelve months of
donation.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-383/384-7.
CODE Unit #KR93443.
MANUFACTURER The Blood Center of Central Iowa, Des Moines,
Iowa.
RECALLED BY Manufacturer, by telephone on October 22,
1996, and by letter dated November 14, 1996.
Firm-initiated recall complete.
DISTRIBUTION Louisiana and California.
QUANTITY 1 unit of each component.
-7-REASON Blood products were collected from a donor
taking the drug Proscar.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets, Pheresis. Recall #B-323-7.
CODE Unit numbers 32P16021 and 32P16243.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated March 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 2 units were distributed.
REASON Blood products tested initially reactive for
the hepatitis B surface antigen (HBsAg), and
were not retested in duplicate, or which
tested negative for HBsAg, were collected from
a donor who was previously tested incorrectly
for HBsAg.
_______________
PRODUCT Recovered Plasma. Recall #B-339-7.
CODE Unit numbers: 30G04947, 30N20313, 30H60926,
30X51767, 30H42151.
MANUFACTURER American Red Cross Blood Services, Ashley,
Pennsylvania.
RECALLED BY Manufacturer, by letter on July 19, 1995.
Firm-initiated recall complete.
DISTRIBUTION New York California, Switzerland.
QUANTITY 5 units were distributed.
REASON Blood products tested negative for the
hepatitis B surface antigen (HBsAg), but were
collected from a donor who previously tested
repeatedly reactive for HBsAg. The donor has
met reentry.
_______________
PRODUCT Platelets. Recall #B-346-7.
CODE Unit numbers: 4701001, 4701002, 4701003,
4701004, 4701007, 4701008, 4701010, 4701011,
4701998, 4701999.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on July 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 10 units were distributed.
REASON Blood products were labeled with an extended
expiration date.
-8-_______________
PRODUCT Red Blood Cells. Recall #B-350-7.
CODE Unit #416402.
MANUFACTURER Memorial Blood Centers of Minnesota,
Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone on July 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT Red Blood Cells. Recall #B-351-7.
CODE Unit #387972.
MANUFACTURER Memorial Blood Centers of Minnesota,
Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter dated August 6, 1996.
Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product tested reactive for syphilis by
RPR.
_______________
PRODUCT Platelets. Recall #B-352-7.
CODE Unit numbers: 5593331 and 5593341.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on August 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 2 units were distributed.
REASON Blood products were not stored under
continuous agitation.
_______________
PRODUCT Platelets. Recall #B-358-7.
CODE Unit numbers: 2645245 and 4109025.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on September 29,
1995, and by letter dated october 9, 1995.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with an extended
expiration date.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Source
Leukocytes; (d) Recovered Plasma.
Recall #B-359/362-7.
-9-CODE Unit #2455593.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter dated July 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a tissue transplant (eye implant)
within a year of donation.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-363/365-7.
CODE Unit #2958623.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter dated July 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana, Missouri, New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
previously tested positive for syphilis.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-366/369-7.
CODE Unit numbers: (a) 2947365, 3708945, 2938592;
(b) 2947365; (c) 2947365; (d) 3708945,
2938592.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter dated July 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana, Missouri, New Jersey.
QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit; (d) 2
units were distributed.
REASON Blood products were collected from a donor who
previously tested positive for gonorrhea.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-370/371-7.
CODE Unit #2463162.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter dated July 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana, New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of venereal disease.
-10-
RECALLS AND FIELD CORRECTIONS: RECALLS AND FIELD
CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Acoma Overhead Tube Support Model A90000-9, a
fully counter-balanced heavy-duty radiographic
x-ray tube suspension system.
Recall #Z-240-7.
CODE Serial numbers 05010194001 through
05010895018; All units shipped between 1/26/94
and 9/30/95.
MANUFACTURER Acoma Medical Imaging, Inc., Wheeling,
Illinois.
RECALLED BY Manufacturer, by sending Equipment Field
Modification Bulletin No. 97-01-OTS-001, Acoma
Recall #1451001-1996-00001, on January 21,
1997. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 136 units were distributed.
REASON Screw heads may come off and allow the plate
at the end of the bridge to fall off.
_______________
UPDATE Medtronic Indura Model 8703W Intraspinal
Catheter, Recall #Z-223-7 which appeared in
the February 12, 1997 Enforcement Report has
been updated to include an additional lot
number, 41524. Quantity should read: 1,196
catheters were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT BVS Blood Pump, used with the Abiomed BVS 5000
Bi-Ventricular Support Systems.
Recall #Z-222-7.
CODE Control numbers beginning with G96, H96, I96,
J96, D96 (Only part of D96 is affected: Pumps
with control numbers ending in P48, P50, P51,
P52, P54, P55, and P56) and E96, F96.
MANUFACTURER Abiomed, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter on November 7, 1996,
and by fax on January 30, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Japan, Netherlands, Switzerland.
QUANTITY 321 units were distributed.
REASON The pump is subject to leakage which occurs at
the outflow connector (bottom of the pump).
_______________
PRODUCT Chartr ENG System, a computer based
electronystagmograph used as a diagnostic
tool. Recall #Z-252-7.
-11-CODE All units shipped prior to 11/22/96.
MANUFACTURER ICS Medical Corporation, Schaumburg, Illinois.
RECALLED BY Manufacturer, by letter dated November 22,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Egypt, Wales, Portugal, England,
Canada.
QUANTITY 32 units were distributed.
REASON The keyboard will lock up if a certain
sequence of keys is entered.
-12-
END OF ENFORCEMENT REPORT FOR FEBRUARY 19, 1997. BLANK PAGES MAY
FOLLOW.
####
End of Enforcement Report for
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