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
12/26/1990
FDA Enforcement for the week of DECEMBER 26, 1990
FDA ENFORCEMENT REPORT
FOR DECEMBER 26, 1990
December 26, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Guiatuss PE Expectorant Decongestant, 4 fluid ounces
(118 ml), an OTC product for the temporary relief of cough
and nasal congestion due to the common cold.
Recall #D-127-1.
Code: Lot F014 EXP 8/91.
Manufacturer: Thames Pharmacal Company, Inc., Ronkonkoma, New York.
Recalled by: Manufacturer, by letter October 25, 1990. Firm-initiated
recall ongoing.
Distribution: New York.
Quantity: 7,260 bottles were distributed and 4,517 bottles have
been returned. Of the remaining 2,743 bottles, the
firm estimates less than 10% remain on the market.
Reason: The correctly stated dosage instructions on the bottle
label are at variance with the statements on the unit carton.
----
Product: Erythromycin Ophthalmic Ointment (5 mg/g), an Rx sterile
ophthalmic antibiotic, in 1 gram tubes under the Pharmafair,
H.L. Moore, Akorn, Lowgen, Goldline and Best labels.
Recall #D-128-1.
Code: Lot numbers and EXP dates: 8268 EXP 9/91, 8743 EXP 10/91,
8685 EXP 8/91, 8685 EXP 8/93.
Manufacturer: Pharmafair, Inc., Hauppauge, New York.
Recalled by: Manufacturer, by letter August 7, 1990. Firm-initiated
recall ongoing.
Distribution: New York, Florida, Louisiana.
Quantity: 304,257 tubes were distributed; firm estimates no more than
5 percent remains on the market.
Reason: Subpotent.
----
Product: Abbott Pentothal Transfer Kit, Thiopental Sodium
for injection, USP, a Schedule III Rx I.V. anesthetic:
(a) 1 g/2.5% Kit (25 mg/ml); (b) 2.5 g/2% Kit (20 mg/ml);
(c) 2.5 g/2.5% Kit (25 mg/ml). Recall #D-130/132-1.
Code: List No. Lot No.
(a) 6244 32-729-DK
(b) 6259 33-328-DK, 33-360-DK
(c) 6260 29-655-DK, 32-699-DK, 32-714-DK,
33-329-DK, 33-353-DK, 32-728-DK,
35-255-DK, 38-614-DK.
Manufacturer: Abbott Laboratories, Rocky Mount, North Carolina.
Recalled by: Abbott Laboratories, Abbott Park, Illinois, by letter
November 16, 1990. Firm-initiated recall ongoing.
-2-
Distribution: Nationwide, Canada.
Quantity: 7,574 cases were distributed; firm estimates 440 cases
remain on the market.
Reason: Subpotency due to precipitate of active ingredient
upon reconstitution.
----
Product: Cal-Lite 1000, in 315 capsule bottles, an OTC product.
Recall #D-137-1.
Code: All lots.
Manufacturer: Contract Pharmaceutical Corporation, Hauppauge, New York.
Recalled by: Futurebiotics, Inc., Brattleboro, Vermont, by letter
December 7, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Singapore, Puerto Rico.
Quantity: Unknown.
Reason: Product marketed without new drug approval.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-055/056-1.
Code: Unit #35H82325.
Manufacturer: American Red Cross, Roanoke, Virginia.
Recalled by: Manufacturer, by telephone November 10, 1989. Firm-
initiated recall complete.
Distribution: Virginia, California.
Quantity: 1 unit of each component.
Reason: Blood products drawn from a donor who participated in
high risk behavior were distributed.
----
Class III -
Product: Genetco Nystatin and Triamcinolone Acetonide Cream USP,
15g tube, an Rx antifungal cream for dermatologic use and
Fluocinonide Cream .05% an Rx glucocorticoid for
dermatologic use. Recall #D-123-1.
Code: Lot #9J48 EXP 10/91.
Manufacturer: Taro Pharmaceutical, Inc., Ontario, Canada.
Recalled by: Taro Pharmaceutical USA Inc., Harrison, New York, by
telephone in January or March of 1990. Firm-initiated
field correction ongoing.
Distribution: New York.
Quantity: 2,880 units were distributed.
Reason: A tube of Nystatin and Triamcinolone Acetonide Cream was
found in a unit carton labeled Fluocinonide Cream.
----
Product: Fluocinonide Cream USP Vasoderm Cream .05%, in 15
gram tubes, an Rx topical glucocorticoid for
dermatological use. Recall #D-124-1.
-3-
Code: Lot numbers L9K46 EXP 5/92, LOE32 EXP 11/92.
Manufacturer: Taro Pharmaceuticals, Inc., Downsville, Canada.
Recalled by: Taro Pharmaceuticals USA, Inc., Hawthorne, New York, by
letter September 28, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 18,664 tubes were distributed.
Reason: Label errors. The net contents reads 5G instead of the
correct 15G statement. Additionally, the statement "not for
Ophthalmic use" reads incorrectly as "Lot for Ophthalmic
use".
----
Product: Enrich International "Product Information Sheets" and the
"ChloroPlasma" Brochure. Product information sheets for
various OTC products listed as follows:
ENHANCE, product #2400; STRESS AID, product #3107;
RED CLOVER PLUS AND RED CLOVER PLUS CAPS, product #C-2380;
MAXI-CHEL, product #E-413; COLDCAP, product #3145;
R.E.V., product numbers: 905, 906, 912, 914;
WATERGONE, product #3200; CHLOROPLASMA, product #C-2500
COQ10, product #C-4125; NATURE'S DIET TEA, product #585;
IMMUNE PLUS, product #4150; PERFORM, product #B-907;
ALLERCALM, product #3100; SLB, product #B-145;
ENDIDA, product #B-418; AQUAPRIMA, product #903;
PMS AID, product #3108; R.E.V. CAPS, product #904.
Recall #D-125-1.
Code: Not coded.
Manufacturer: Enrich International, Lindon, Utah.
Recalled by: Manufacturer, by letter October 31, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: Firm estimates none remains on the market.
Reason: Promotional material contains misleading and unapproved
therapeutic claims.
----
Product: Marnel brand Pre-Hist-D Capsules, in 100 capsule bottles,
Rx antihistamine/nasal decongestant/anticholinergic long
acting capsules. Recall #D-126-1.
Code: Lot XGR EXP 4/92.
Manufacturer: Central Pharmaceuticals, Inc., Seymour, Indiana.
Recalled by: Manufacturer, by telephone September 19, 1990 followed
by letter September 24, 1990. Firm-initiated recall
complete.
Distribution: Louisiana.
Quantity: 4,685 bottles were distributed.
Reason: Mislabeling; package insert lacks the third active
ingredient, Methscopolamine Nitrate 2.5 mg. Bottle label
is correct.
----
-4-
Product: Prochlorperazine Edisylate Injection, USP, 10mg/2 ml,
(5 mg/ml) 2 ml amber dosette ampules and 2 ml amber dosette
vials, an Rx antiemetic and antipsychotic for intramuscular
or intravenous use. Recall #D-129-1.
Code: Lot numbers: 040171, 050167, 119176, 119178, 030166, 050170.
Manufacturer: Elkins-Sinn, Inc., Cherry Hill, New Jersey.
Recalled by: Manufacturer, by letter November 13, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 1,575,900 units were distributed.
Reason: Presence of particulate matter.
----
Product: Aminophylline Tablets, USP, (a) 100 mg; (b) 200 mg,
an Rx oral medication used for treatment of asthma, in
unit dose packaged 10 strips of 10 tablets per shelf
carton, 10 cartons per case. Recall #D-133/134-1.
Code: Lot numbers: (a) 9F937, 9F942, 9K395, 9K434, 9V893,
0F369, 0F377; (b) 9B677, 9F898, 9H195, 9M507, 9M480,
9S799, 0B138, 0J664.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois (repacker), by
letter September 14, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 4,795 unit cartons; (b) 6,733 unit cartons were
distributed; firm estimates 50% of the product remains
on the market.
Reason: Some lots fail USP specifications for Ethylenediamine
content.
----
Product: Conjugated Estrogen Tablets, USP, in bottles of 100 and
1,000 tablets, used for treating estrogen deficiencies
in post-menopausal women, under the Duramed, Geneva,
Schein, Major, Parmed, Qualitest, Rugby and URL labels:
(a) 0.3 mg; (b) 1.25 mg. Recall #D-135/136-1.
Code: Lot numbers: (a) 91995, 92011; (b) 92016, 92158, 92162.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by telephone October 12, 1990 followed by
letter. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 4,850,000 tablets were distributed.
Reason: Products fail USP dissolution test.
----
Product: Aluminum & Magnesium Hydroxides with Simethicone
Antacid, an OTC oral liquid antacid in 30 ml unit
dose cups, 10 cups per shelf carton, 5 shelf cartons
per half case, and 12 fluid ounce bottles, 12 bottles
per case. Recall #D-138-1.
Code: Lot numbers: 910013, 910014.
-5-
Manufacturer: UDL Laboratories, Inc., Largo, Florida.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter
October 24, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 16,068 twelve ounce bottles and 121 half cases of 30 ml
unit dose cups were distributed; firm estimates 25%
of the product remains on the market.
Reason: Product is subpotent for simethicone ingredient.
----
Product: Ibuprofen Tablets, 600 mg (round shaped only), an Rx product
in bottles of 100 and 500 tablets under Boots Laboratories,
Major, Interstate Drug Exchange, Goldline, Mason, Parmed,
H.L. Moore, Qualitest and Warner Chilcott labels.
Recall D-139-1.
Code: All lots with expiration dates from 5/91 through 12/92. This
involves 157 different lots as follows:
B4019, B4374, B4578, B4850, B5090, B5185, B5282, B4214,
B4375, B4579, B4851, B5091, B5186, B5283, B4215, B4421,
B4620, B4852, B5092, B5221, B5284, B4232, B4422, B4621,
B4901, B5093, B5220, B5285, B4233, B4423, B4622, B4902,
B5094, B5222, B5286, B4234, B4424, B4623, B4903, B5119,
B5223, B5362, B4271, B4425, B4624, B4904, B5120, B5224,
B4235, B4440, B4625, B4905, B5121, B5225 (954N9W),
B4272, B4441, B4626, B4957, B5122, B5226, B4273, B4442,
B4627, B4906, B5123, B5227, B4274, B4443, B4628, B4958,
B5124, B5228, B4275, B4444, B4629, B4959, B5125 (93289WB),
B5229, B4344, B4445, B4753, B4960, B5126, B5230, B4345,
B4446, B4754, B4961, B5127 (93289WA), B5231, B4346, B4447,
B4755, B5080, B5144, B5232, B4347, B4448, B4756, B5081,
B5145, B5233, B4348, B4522, B4757, B5082, B5146, B5234,
B4349, B4449, B4758, B4962, B5147, B5235, B4350, B4525,
B4759, B5084, B5148, B5278, B4369, B4524, B4760, B5086,
B5149, B5277, B4370, B4523, B4761, B5085, B5182, B5276,
B4371, B4526, B4762, B5083, B5187, B5236, B4372, B4527,
B4763, B5087, B5184, B5279, B4373, B4576, B4764, B5088,
B5183, B5280, B4575, B4848, B5089, B5150, B5281, B4577,
B4849.
Manufacturer: Boots Pharmaceuticals, Shreveport, Louisiana.
Recalled by: Manufacturer, by letter December 5, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico, Guam.
Quantity: 240,343 bottles of 100 tablets and 470,273 bottles of
500 tablets were distributed; firm estimates none remains
on the market.
Reason: Product does not meet dissolution specifications through
expiration date.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
-6-
Class II -
Product: Blood Pressure Monitoring Kits and components, under the
"Medi-Trace" or "Accutran" labels, used to monitor a
patient's blood pressure from an existing arterial catheter.
Recall #Z-131/143-1.
(a) Standalone (Component)
1520 Standalone DPT without Flush Device
1550 Adult Standalone DPT, 3 cc Flush Device
1552 Neonatal Standalone DPT, 30 cc Flush Device
1621 Standalone DPT without Flush Device & Venting Stopcock
1651 Adult Standalone DPT, 3 cc Flush Device
1653 Neonatal Standalone DPT, 30 cc Flush Device
(b) Single Line (Component)
6501 Single Line DPT, Pole Mount, Macro
6503 Single Line, DPT, Pole Mount, Micro
6531 Neonatal DPT, 30 cc Flush Device
6540 Single Line, DPT, Pole Mount
6541 Single Line, DPT, Patient Mount
6543 Single Line, DPT, Pole Mount, Operating Room Use
(c) Bifurcate (Component)
6520 Bifurcate DP System, 1 Transducer
6524 Bifurcate DP System, 2 Transducers
6523 Bifurcate DP System, 2 Transducers
(d) Trifurcate (Component)
6521 Trifurcate DPT System, 2 Transducers
6522 Trifurcate DPT System, 3 Transducers
6525 Trifurcate DPT System, 3 Transducers
(e) PA Bridges (Component)
6511 Pulmonary Artery Bridge, Flush Device &
IV Administration Set
6512 Pulmonary Artery Bridge
(f) Disposable Domes (Component)
2000 Disposable Dome - Bentley Trantec Transducer,
Linden
2001 Disposable Dome - Bentley Trantec Transducer,
Luer
2100 Disposable Dome - Spectramed P231d Transducer,
Linden
2101 Disposable Dome - Spectramed P231d Transducer,
Luer
2200 Disposable Dome - HP 1280, Linden
2201 Disposable Dome - HP 1280, Luer
2220 Disposable Dome - 1290 & 1295 Quartz Transducer
2300 Disposable Dome - B&H 4-327 (Corometrics) Transducer,
Linden
2301 Disposable Dome - B&H 4-327 (Corometrics) Transducer,
Luer
-7-
(g) Stopcocks (Component)
4000 Stopcock - 3 Way, Luer Lock Polycarbonate
4001 Stopcock - 4 Way, Luer Lock Polycarbonate
4005 Stopcock - 1 Way, Luer Lock Polycarbonate
4012 Stopcock - 3 Way, Male Luer Slip, Nylon
4015 Stopcock - 3 Way, Luer Slip, Nylon
4016 Double Stopcocks - 3 Way, Luer Lock, Polycarbonate
4017 Double Stopcocks - 4 Way, Luer Lock, Polycarbonate
4018 Stopcock - 4 Way, Luer Slip, Nylon
4300 M/F Luer Deadend Cap
4400 M/M Adaptor
(h) Flush Devices (Component)
5100 Adult 3 cc Flush Device, M/F
5130 Neonatal 30 cc Flush Device, M/F
5200 Adult 3 cc Flush Device, Flow Through, Female Luer
5230 Neonatal 30 cc Flush Device, Flow Through, Female Luer
(i) Administration Sets (Component)
3000 Administration Set, Single, Macro
3001 Administration Set, Double, Macro
3002 Administration Set, Single, Micro
3003 Administration Set, Double, Micro
3004 Administration Set, Triple, Macro
3005 Administration Set, Triple, Micro
(j) Extension Sets (Component)
4106 Extension Set, 3 Way Stopcock, 6" Line
4112 Extension Set, 3 Way Stopcock, 12" Line
(k) Pressure Monitoring Lines (Component)
30206 6" Pressure Line, M/F
30212 12" Pressure Line, M/F
30224 24" Pressure Line, M/F
30230 30" Pressure Line, M/F
30236 36" Pressure Line, M/F
30248 48" Pressure Line, M/F
30260 60" Pressure Line, M/F
30272 72" Pressure Line, M/F
30284 84" Pressure Line, M/F
30006 6" Pressure Line, M/M
30012 12" Pressure Line, M/M
30024 24" Pressure Line, M/M
30036 36" Pressure Line, M/M
30048 48" Pressure Line, M/M
30060 60" Pressure Line, M/M
30072 72" Pressure Line, M/M
30084 84" Pressure Line, M/M
39206 6" Neonatal Pressure Tubing, M/F
39212 12" Neonatal Pressure Tubing, M/F
39224 24" Neonatal Pressure Tubing, M/F
39236 36" Neonatal Pressure Tubing, M/F
-8-
39248 48" Neonatal Pressure Tubing, M/F
39260 60" Neonatal Pressure Tubing, M/F
39006 6" Neonatal Pressure Tubing, M/F
39012 12" Neonatal Pressure Tubing, M/F
39024 24" Neonatal Pressure Tubing, M/F
39036 36" Neonatal Pressure Tubing, M/F
39048 48" Neonatal Pressure Tubing, M/F
39060 60" Neonatal Pressure Tubing, M/F
(l) Disposable Pressure Monitoring Kits
6202 Universal Disposable Monitoring Kit without
Dome, 3 cc Flush Device, Macro
6302 Universal Disposable Monitoring Kit without
Dome, 3 cc Flush Device, Micro
6202-2000 Disposable Monitoring Kit - Bentley Model
800 Transducer
6202-2100 Disposable Monitoring Kit - Spectramed
P231d Transducer
6202-2220 Disposable Monitoring Kit - HP 1280 Series
Transducer
6202-2220 Disposable Monitoring Kit - HP 1290 Series
Transducer
6202-2300 Disposable Monitoring Kit - B&H 4-3271 Transducer
6300 Universal Disposable Monitoring Kit without
Dome, 3 cc Flush Patient Mount
6300-2000 Disposable Monitoring Kit - Bentley Model
800 Transducer, Patient Mount
6300-2100 Disposable Monitoring Kit - Spectramed
P231d Transducer, Patient Mount
6300-2200 Disposable Monitoring Kit - HP 1280 Series
Transducer, Patient Mount
6300-2220 Disposable Monitoring Kit - HP 1290 Series
Transducer, Patient Mount
6300-2300 Disposable Monitoring Kit - B&H 4-3271
Transducer, Patient Mount
6330-2000 Disposable Neonatal Monitoring Kit, 30 cc
Flush - Bentley Model 800 Transducer
6330-2100 Disposable Neonatal Monitoring Kit, 30 cc
Flush - Spectramed P231d Transducer
6330-2200 Disposable Neonatal Monitoring Kit, 30 cc
Flush - HP 1280 Series Transducer
6330-2220 Disposable Neonatal Monitoring Kit, 30 cc
Flush - HP 1290 Series Transducer
6330-2300 Disposable Neonatal Monitoring Kit, 30 cc
Flush B&H 4-3271 Transducer
(m) Custom Devices
7029 For Reusable Transducer
7030 For Reusable Transducer
7029-1 For Reusable Transducer
7030-1 For Reusable Transducer
7180 For Reusable Transducer
7381 For Reusable Transducer
-9-
7421 For Reusable Transducer
7466 For Reusable Transducer
7506 Custom Component
7515 For Reusable Transducer
N7533 For Reusable Transducer
7536 DPT Custom Kit
7538 For Reusable Transducer
7557 For Reusable Transducer
7566 For Reusable Transducer
7581 For Reusable Transducer
7584 For Reusable Transducer
N7603 For Reusable Transducer
7618 For Reusable Transducer
7624 For Reusable Transducer
7636 For Reusable Transducer
7641 Custom Component
7642 Custom Component
7644 For Reusable Transducer
7652 DPT Custom Kit
7653 DPT Custom Kit
7654 DPT Custom Kit
N7655-16 DPT Custom Kit
N7676 For Reusable Transducer
7686 For Reusable Transducer
7697 DPT Custom Kit
7711 For Reusable Transducer
N7712 DPT Custom Kit
7730 For Reusable Transducer
7731 DPT Custom Kit
N7744 DPT Custom Kit
7748 For Reusable Transducer
7766 For Reusable Transducer
7785 For Reusable Transducer
7786 DPT Custom Kit
7794 For Reusable Transducer
7808 For Reusable Transducer
7809-16 DPT Custom Kit
7812 DPT Custom Kit
7820 For Reusable Transducer
7821 Custom Component
N7823 DPT Custom Kit
7826 Custom Component
7830 DPT Custom Kit
N7836 DPT Custom Kit
N7837 DPT Custom Kit
7838 DPT Custom Kit
7839 DPT Custom Kit
7840 DPT Custom Kit
7842 DPT Custom Kit
7892 For Reusable Transducer
7893 For Reusable Transducer
7896 DPT Custom Kit
7915 DPT Custom Kit
-10-
7918 Custom Component
7921-16 DPT Custom Kit
N7922-16 DPT Custom Kit
N7923-16 DPT Custom Kit
7928 DPT Custom Kit
7930 For Reusable Transducer
N7933-16 DPT Custom Kit
7946-16 DPT Custom Kit
7947 For Reusable Transducer
7948 For Reusable Transducer
7953 For Reusable Transducer
7960-16 DPT Custom Kit
7972 DPT Custom Kit
7986 For Reusable Transducer
70007-16 DPT Custom Kit
70011 DPT Custom Kit
70013-16 DPT Custom Kit
70015 DPT Custom Kit
70016 DPT Custom Kit
70017 DPT Custom Kit
Code: All product identification codes listed above and all
lots.
Manufacturer: Graphic Controls Corporation, Methuen, Massachusetts
(assembler/packager).
Recalled by: Graphic Controls Corporation, Buffalo, New York, by
letter November 8, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 80,000 pouches are on the market.
Reason: Foreign materials (fibers and/or particles) are present
within the device packages, probably due to static
electricity build up in the packaging machines.
----
Class III -
Product: Spore Ampule Biological Indicators, in 1.9 ml ampules,
a unitary biological indicator labeled for use with steam,
washer/sterilizer, and chemical vapor sterilization
processes, packaged under the Sporview SporAmpule and
ConFirm SporAmpule label. Recall #Z-160-1.
Code: All lot numbers.
Manufacturer: Becton Dickinson Microbiology Systems, Hunt Valley,
Maryland.
Recalled by: SPS Medical Supply Corporation, Rochester, New York,
by telephone November 16, 1990 followed by letter
November 21, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 43,600 ampules were distributed; firm estimates less than
1 percent remains on the market.
-11-
Reason: The devices were marketed without submission
of a 510(k) by the firm and determination of substantial
equivalency by the Food and Drug Administration for the
chemical vapor sterilization label claim.
----
Product: Spore Strip Biological Indicators, recommended for
monitoring steam, chemical vapor, ethylene oxide gas, and
dry heat sterilization processes, under the Passport
Sterility Assurance System and Sporview Sterility
Assurance System trade names. Spore strips are packaged
into double pocket envelopes containing two test strips
and one control strip. The PassPort Sterility System
is packaged in 12 packs and 52 packs. Each pack consists
of one envelope of two test spore strips and one
control spore strip. Spore strips are also
shipped in packages of 500 test strips or 500 control
strips per plastic bag with an accompanying certificate of
performance, under the SPS Medical Sterilization label.
The PassPort Sterility Assurance System is manufactured
under the firm's SPS Medical trade name and 22 private
labels: University of Texas Health Science Center at
Houston, Dental Branch; Koley's Medical Supply Co., Inc.;
Southeastern Hospital Supply; Bedsole Medical, Birmingham,
AL; Bedsole Medical, Jackson, MS; Randolph/Geneva Hospital
Supply; Randolph; Midwest Hospital; Irco Medical; Medical
Mart; United Medical; Taylor Medical; Bedsole Medical,
Mobile, AL; Meyers & Co./Seneca Medical; Randolph Medical
Ohio; Midwest Medical; Emery Medical; James Phillips;
Marcus Dental; Claflin Co., Stuarts; Taylor Medical.
Recall #Z-161-1.
Code: All lot numbers.
Manufacturer: SPS Medical Supply Corporation, Rochester, New York
(repacker/relabeler).
Recalled by: Repacker/relabler, by telephone November 16, 1990 followed
by letter November 21, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 20,224 double envelopes of the PassPort Sterility
Assurance System were distributed; firm estimates 25 percent
remains on the market; 60/25 unit test sets of the SporView
Sterility Assurance system were distributed; firm estimates
less than 1 percent remains on the market; 285 bulk
packages of 500 spore strips were distributed; firm
estimates none remains on the market.
Reason: The devices were marketed without submission
of a 510(k) by the firm and determination of substantial
equivalency by the Food and Drug Administration for the
chemical vapor sterilization label claim.
----
-12-
VETERINARY PRODUCTS
NONE
Seizure Actions Filed:
Product: Shengu Leaves (90-592-498) and other herbal products.
Charge: Adulterated - Products were found to contain live and dead
insects, and food containers had apparent rodent urine
stains and rodent excreta pellets on their surfaces;
products were held under insanitary conditions whereby
they may have become contaminated with filth.
Firm: Kwok Shing Import-Export, Inc., San Francisco, California.
Filed: November 28, 1990 - U.S. District Court for the Northern
District of California; Civil #90-3368DLJ, FDC #65965.
----
Product: Angelica Anomala (90-540-617) and other herbal products.
Charge: Adulterated - Products were held under insanitary
conditions whereby they may have become contaminated
with filth.
Firm: May Hing Import and Export, Oakland, California.
Filed: November 28, 1990 - U.S. District Court for the Northern
District of California; Civil #90-3369SAW, FDC #65976.
----
Product: CONS-MARK'S Ping Pongs Candy Beads (91-575-998).
Charge: Adulterated - Product contains unsafe color additive,
Cochineal Red A.
Firm: CONS-MARK, Inc., Glenview, Illinois.
Filed: December 12, 1990 - U.S. District Court for the
Northern District of Illinois, Eastern Division;
Civil #907195, FDC #66006.
----