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
04/24/1990
FDA Enforcement for the week of April 25, 1990
FDA ENFORCEMENT REPORT
FOR APRIL 25, 1990
April 25, 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.
Product: Frozfruit Creamy Banana Ice Milk Confection Bars, each
bar with stick embedded, wrapped in clear plastic bag.
4 ounce bars, packaged 4 bars per box, 12 boxes per case
and single serve gabs (packed 12 or 24 per box).
Recall #F-489-0.
Code: (a) C934621, (b) C0040XX (where XX is the pallet number, e.g.
01, 02, 03, etc.)
Manufacturer: Frozfruit, Inc., Clovis, New Mexico.
Recalled by: Frozfruit, Inc., Gardena, California, (a) by telephone and
letter February 17, 1990; (b) by telephone April 9, 1990.
Firm-initiated recall ongoing.
Distribution: (a) Texas, Alabama; (b) Texas, Illinois, Pennsylvania.
Quantity: (a) 81 cases; (b) 429 cases and 339 boxes of 24 packs
were distributed.
Reason: Product is contaminated with Listeria monocytogenes.
----
-1-
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.
Product: Now & Later, individually wrapped (paper) candy assorted
fruit chews, artificially flavored, labeled "Marlow" or
"Just Goodies". Recall #F-480-0.
Code: All sizes -- All codes.
Manufacturer: Phoenix Confection, Inc., North Brook, Illinois.
Recalled by: Marlow Candy and Nut Company, Englewood, New Jersey, by
letter January 30, 1990. Firm-initiated recall ongoing.
Distribution: New York, New Jersey, Pennsylvania, Connecticut.
Quantity: Unknown.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Pocono Springs Pure Mountain Spring Water, in 1 gallon
PVC bottles. Recall #F-504-0.
Code: 12/26/91 and 1/4/92.
Manufacturer: Pocono Artesian Waters Company, Inc., Mt. Pocono,
Pennsylvania.
Recalled by: Manufacturer, by telephone and press release January 15,
1990. Firm-initiated recall complete.
Distribution: New Jersey, New York.
Quantity: 1,960 cases (6 gallons/case) were distributed; firm
estimated 4,000 gallons remained on market when the
recall was initiated.
Reason: Product contained chemical (kerosene/petroleum-like) odor.
----
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
Product: Coca Cola Classic, in 16 ounce non-returnable bottles,
six bottles attached to rigid tray. Recall #F-467-0.
Code: Lot #0050H.
Manufacturer: Central Coca Cola Bottling Co., Inc., Hagerstown,
Maryland.
Recalled by: Central Coca Cola Bottling Company, Inc., Richmond,
Virginia, by visit February 23, 1990. Firm-initiated
recall ongoing.
Distribution: Virginia, Maryland, Ohio, Pennsylvania.
-2-
Quantity: 1,000 cases were distributed.
Reason: Product is contaminated with oil.
----
Product: Pasta Accents, Garlic Seasoning, Vegetables and Pasta
in a Garlic Seasoned Sauce, a frozen product in a 16 ounce
plastic bag. Recall #F-468-0.
Code: Lot numbers L9P16, A0P20, A0P24, A0P25, A0P30, B0P07,
B0P08, B0P15, B0P16.
Manufacturer: Green Giant Company, Division of the Pillsbury Company,
Belvidere, Illinois, Bermuda.
Recalled by: The Pillsbury Company, Minneapolis, Minnesota, by letter
March 9, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 18,724 cases (12 bags/case) were distributed.
Reason: Product is contaminated with styrene.
----
Product: Richardson (a) After Dinner Butter Mints, in 12 ounce bags
and in 25 pound bulk containers; (b) After Dinner Assorted
Jelly Center Candy Mints, in 5 pound pur-packs.
Recall #F-473/474-0.
Code: Lot numbers: (a) 93121 and 93101 (12 oz), 00111 and 00331
(bulk); (b) 00321.
Manufacturer: Richardson Brands, Inc., Philadelphia, Pennsylvania.
Recalled by: Manufacturer, by telephone March 10, 1990. Firm-initiated
recall complete.
Distribution: Minnesota, Ohio, Georgia, Michigan, Pennsylvania, Indiana,
South Carolina.
Quantity: Firm estimates 250 cases remain on market.
Reason: Products are contaminated with insect and rodent filth.
----
Product: Maitre Jacques White Wine Vinegar Lemon, in 16 ounce
bottles. Recall #F-479-0.
Code: All lots.
Manufacturer: Reine Dijon ets Theveniaud, Plombiers, Dijon, France.
Recalled by: Haddon House Food Products Inc., Medford, New Jersey, by
letter November 28, 1989. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 18 cases (12 bottles/case) were distributed.
Reason: Product contains undeclared sulfites.
----
Product: Aceto Sasso Wine Vinegar, in 17 ounce bottles.
Recall #F-481-0.
Code: All codes.
-3-
Manufacturer: Nestle Italiana, S.P.A. Viale Bianca Maria, Milano, Italy.
Recalled by: Haddon House Food Products Inc., Medford, New Jersey, by
letter November 28, 1989. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 153 cases (20 bottles/case) were distributed.
Reason: Product contains undeclared sulfites.
----
Product: "3 Glocken Black Forest Girl" enriched egg noodle
products, in 8.8 ounce packages:
(a) Spaetzle; (b) Swabian Style Fancy Broad Noodles;
(c) Little Posthorns; (d) Homemade Spaetzle;
(e) String Nests; (f) Extra Broad Noodles.
Recall #F-482/487-0.
Code: All codes.
Manufacturer: 3 Glocken GMBH, Weinheim, West Germany.
Recalled by: Haddon House Food Products Inc., Medford, New Jersey,
by letter March 17, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 1,200 cases were distributed.
Reason: Product does not meet the food standard requirement for iron.
----
Product: Triton Spring Water in clear PVC plastic 1 gallon jugs.
Recall #F-505-0.
Code: All lots.
Manufacturer: Triton Water Company, Burlington, North Carolina.
Recalled by: Alamance Foods, Burlington, North Carolina, by telephone
February 8, 1990. Firm-initiated recall ongoing.
Distribution: North Carolina, Pennsylvania, Virginia, West Virginia.
Quantity: Firm estimates little product remains on market.
Reason: Product is contaminated with mold.
----
Product: Bunte Jelly Bird Eggs (jelly bean type candy), in 12
ounce plastic bags. Recall #F-506-0.
Code: Lot numbers: 2DD923, 4DE911.
Manufacturer: Bunte General Corporation, Oklahoma City, Oklahoma.
Recalled by: Manufacturer, by telephone March 2 and 5, 1990 followed
by letter March 9, 1990. Firm-initiated recall ongoing.
Distribution: Georgia.
Quantity: 935 cases (24 packages/case) was distributed.
Reason: Product is contaminated with wood fragments.
----
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
Product: H.L. Moore brand Warfarin, 5 mg tablets, an Rx
blood thinner, in bottles of 100. Recall #D-229-0.
Code: Lot numbers: G873-01, G685-08.
Manufacturer: Pharmaceutical Basics Inc. (PBI), Denver, Colorado.
Recalled by: Manufacturer, by telephone March 29-30, 1990 followed by
letter March 29, 1990. Firm-initiated recall ongoing. See
also FDA press release P90-23, March 29, 1990.
Distribution: Nationwide, Virgin Islands, Puerto Rico.
Quantity: 600 bottles were distributed.
Reason: A bottle of H.L. Moore's brand Warfarin Sodium 5 mg Tablets
was found mislabeled as H.L. Moore brand Desipramine HCl 25
mg. tablets.
----
Class II -
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma. Recall #B-110/112-0.
Code: Unit number #7465563.
Manufacturer: The Greater New York Blood Program, Manhattan, New York.
Recalled by: Manufacturer, by telephone March 23, 1989 followed by letter
October 17, 1989. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 1 unit of each component was distributed.
Reason: Blood products collected from donors who had previously
tested repeatably reactive for the antibody to the
human immunodeficiency virus (anti-HIV-1) were distributed.
----
Product: Red Blood Cells. Recall #B-125-0.
Code: Unit #15F86413.
Manufacturer: American Red Cross Blood Services, Great Falls, Montana.
Recalled by: Manufacturer, by telephone November 3, 1988. Firm-
initiated recall complete.
Distribution: Montana.
Quantity: 1 unit was distributed and was destroyed.
Reason: Unit of Red Blood Cells drawn from a donor who
previously tested repeatably reactive for the antibody
to the human immunodeficiency virus (anti-HIV-1) was
distributed.
----
-5-
Product: Red Blood Cells. Recall #B-126-0.
Code: Unit #18H68668.
Manufacturer: American Red Cross Blood Services, Lansing, Michigan.
Recalled by: Manufacturer, by telephone August 18, 1989. Firm-
initiated recall complete.
Distribution: Michigan.
Quantity: 1 unit was distributed and was destroyed.
Reason: Unit of Red Blood Cells which tested repeatably
reactive for the antibody to the human T-lymphotropic
virus, type 1 (anti-HTLV-1) was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-130/131-0.
Code: Unit 60-13414.
Manufacturer: Community Blood Center, Inc., Appleton, Wisconsin.
Recalled by: Manufacturer, by telephone December 7, 1989. Firm-
initiated recall complete.
Distribution: Wisconsin.
Quantity: 1 unit of each component was distributed.
Reason: Blood components drawn from a patient with a history of
hepatitis were distributed.
----
Class III -
Product: Lilly Ergotrate Maleate brand Ergonovine Maleate Tablets
USP, 0.2 mg, in bottles of 100 and 1,000, and ID-100
unit dose cartons (10 strips of 10 blisters each), an
oral Rx drug indicated for the prevention and treatment of
postpartum and postabortel hemmorrhage due to uterine atony.
Recall #D-228-0.
Code: Lot numbers: 2RD02A EXP 6/1/90, 2RD02B EXP 6/1/90,
2RD02C EXP 6/1/90, 2RR22A EXP 9/1/90.
Manufacturer: Eli Lilly and Company, Indianapolis, Indiana.
Recalled by: Manufacturer, by letter March 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Netherlands, Dominican Republic, Bermuda,
Virgin Islands, Haiti, Australia.
Quantity: 17,495/100 tablet bottles (lot 2RD02A), 8,005/100 unit
dose cartons (lot 2RD02B), 1,137/1000 tablet bottles
(lot 2RD02C), 35,614/100 tablet bottles (lot 2RR22A)
were distributed; firm estimates very little to none
remains on market.
Reason: Product does not meet USP related alkaloids test.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-113/116-0.
Code: Unit numbers: (a & b) 738239, 7425190; (c) 7383239;
(d) 7425190.
-6-
Manufacturer: The Greater New York Blood Program, Manhattan, New York.
Recalled by: Manufacturer, by telephone March 23, 1989 followed by
letter October 17, 1989. Firm-initiated recall complete.
Distribution: New York.
Quantity: (a & b) 2 units; (c & d) 1 unit was distributed.
Reason: Blood products collected from donors who had previously
tested repeatably reactive for the antibody to the
human immunodeficiency virus (anti-HIV-1) were distributed.
----
Product: Recovered Plasma. Recall #B-123-0.
Code: Unit #36-024-8541.
Manufacturer: United Blood Services, Ventura, California.
Recalled by: Manufacturer, by telephone December 5, 1999. Firm-initiated
recall complete.
Distribution: North Carolina.
Quantity: 1 unit was distributed.
Reason: Recovered Plasma which tested repeatably reactive for the
Hepatitis B Surface Antigen (HBsAg) was distributed.
----
Product: Recovered Plasma. Recall #B-124-0.
Code: Unit #10-155-7671.
Manufacturer: United Blood Services, Scottsdale, Arizona.
Recalled by: Manufacturer, by telephone July 5, 1989 followed by
letter July 6, 1989. Firm-initiated recall complete.
Distribution: North Carolina.
Quantity: 1 unit was distributed.
Reason: Recovered Plasma, which tested nonreactive for the Hepatitis
B Surface Antigen (HBsAg) but collected from a donor who
previously tested repeatably reactive for HBsAg was
distributed.
----
Product: Red Blood Cells. Recall #B-132-0.
Code: Unit #0430669.
Manufacturer: Coffee Memorial Blood Center, Amarillo, Texas.
Recalled by: Manufacturer, by telephone October 26, 1989. Firm-
initiated field correction (relabeling) complete.
Distribution: Texas.
Quantity: 1 unit was distributed.
Reason: A unit of Red Blood Cells was distributed for transfusion
with an incorrect expiration date.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
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Class II -
Product: Lifecare PLV-102 Portable Volume Ventilator, a micro-
processor controlled positive pressure, volume cycled
ventilator designed especially for the care of patients
(primarily home care) with respiratory disabilities.
Recall #Z-483-0.
Code: Serial numbers 890601 through 900163.
Manufacturer: Computer Optical Products, Chatsworth, California (encoder).
Recalled by: Lifecare Services, Inc., Lafayette, Colorado, by
letter March 5, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 118 units were distributed.
Reason: The optical encoder used to control the piston drive in the
ventilator may produce false signals which could cause the
ventilator to stall (stop), with alarm systems functioning.
----
Product: Latex Examination Gloves: (a) Small; (b) Medium;
(c) Large, in boxes of 100. Recall #Z-484/486-0.
Code: L-89, L-108.
Manufacturer: China National Chemical Import and Export Corp., Hanhou,
China.
Recalled by: Sinochem (U.S.A.), Inc., New York, by letter October
4, 1989. Firm-initiated recall ongoing.
Distribution: Texas, New Jersey, Virginia, New York.
Quantity: 16,227 master cartons (20 boxes/100 pieces) were distributed.
Reason: Products failed the FDA leak test.
----
Product: Sharplan C02 Surgical Laser System, Models (a) 1020;
(b) 1025; (c) 1040; (d) 1060. Recall #Z-489/492-0.
Code: Serial numbers: (a & b) All; (c & d) 25-00 and higher.
Manufacturer: Laser Industries Ltd., Tel Aviv, Israel.
Recalled by: Sharplan Laser Inc., Allendale, New Jersey, by
letters between September 15 and 18, 1989.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 370 units were distributed.
Reason: The footswitch may remain stuck in the closed position
causing prolonged activation of the laser's beam.
----
Product: Sirecust 120D/121D Central Auxiliary Display, a
remote display monitor used with a central patient
monitor system. Recall #Z-497-0.
Code: Software versions: VB0, VB1, TB6.
Manufacturer: Siemens Medical Electronics, Danvers, Massachusetts.
Recalled by: Manufacturer, by Safety Bulletin #8120104 dated November
23, 1988. Firm-initiated field correction complete.
-8-
Distribution: Nationwide and international.
Quantity: 113 units were distributed.
Reason: Several key actions may intermittently cause the
superimposition of one bedside's waveforms on another
bedside's waveforms in the remote view of a central-
station cluster screen. As a result, the waveforms of one
bedside are displayed twice, while the waveforms of the other
bedside are not displayed at all.
----
Product: Gambro Bloodline Sets for Hemodialysis, sterile, single
patient use devices, 16 units/case:
Catalog Numbers: (a) G-514; (b) G-533; (c) G-542;
(d) G-544; (e) G-565. Recall #Z-499/503-0.
Code: Lot Numbers: (a) 9-1156-N; (b) 9-1160-N; (c) 9-1170-N;
(d) 9-1154-N, 9-1159-N, 9-1177-N; (e) 9-1150-N, 9-1174-N.
Manufacturer: Gambro-Hospal, Inc., Newport News, Virginia.
Recalled by: Manufacturer, by letter March 1, 1990 and by telephone
on or about March 5, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 1,776 units were distributed.
Reason: The heparin administration line on the arterial bloodline
may fracture and break/leak under stress when the slide
clamp is utilized.
----
Product: Polyethylene Acetabular Cup Liners, ultra-high molecular
weight polyethylene (UHMWPE) components of hip prosthesis,
which fit into metal cup shells to form the acetabular
component of the hip prosthesis and connect with the ball
end of the hip stem component:
1. Catalog No. 1360-45, Polyethylene Cup Liner, Group 0
(26mm) - Profile Poly Insert;
2. Catalog No. 1360-47, Polyethylene Cup Liner, Group 0
(26mm) - Profile Poly Insert;
3. Catalog No. 1360-49, Polyethylene Cup Liner, Group 0
(26mm) - Profile Poly Insert;
4. Catalog No. 1360-51, Polyethylene Cup Liner, Group 0
(28mm) - Profile Poly Insert;
5. Catalog No. 1360-53, Polyethylene Cup Liner, Group 0
(28mm) - Profile Poly Insert;
6. Catalog No. 1360-55, Polyehtylene Cup liner, Group 0
(28mm) - Profile Poly Insert;
7. Catalog No. 1115-01, Polyethylene Cup Liner, Group I
(28mm);
8. Catalog No. 1115-11, Polyethylene Cup Liner, Group I
(28mm);
9. Catalog No. 1115-21, Polyethylene Cup liner, Group I
(28mm)l
10. Catalog No. 1115-31, Polyethylene Cup Liner, Group I
(26mm);
-9-
11. Catalog No. 1115-36, Polyethylene Cup liner, Group I
(26mm);
12. Catalog No. 1115-41, Polyethylene Cup liner, Group I
(26mm);
13. Catalog No. 1115-02, Polyethylene Cup liner, Group II
(32mm);
14. Catalog No. 1115-12, Polyethylene Cup liner, Group II
(32mm);
15. Catalog No. 1115-22, Polyethylene Cup liner, Group II
(32mm);
16. Catalog No. 1115-03, Polyethylene Cup liner, Group
III (32mm);
17. Catalog No. 1115-13, Polyethylene Cup Liner, Group
III (32mm);
18. Catalog No. 1115-23, Polyethylene Cup Liner, Group
III (32mm);
19. Catalog No. 1360-80-101, Poss ACS Polyethylene Liner,
Group 1 28mm Neutral - Profile Poly Insert;
20. Catalog No. 1115-80-002, ACS Polyethylene with 10`
Lip & Rim 32 Group 2;
21. Catalog No. 1115-80-003, ACS Polyethylene with 10`
Lip & Rim 32 Group 3;
22. Catalog No. 1115-80-004, ACS polyethylene with 10`
Lip & Rim 28 Group 1;
23. Catalog No. 1115-80-005, ACS Polyethylene with 10`
Lip & Rim 32 Group 4;
24. Catalog No. 1115-80-006, ACS Polyethylene with 20`
Lip & Rim 28 Group 1;
25. Catalog No. 1115-80-007, ACS Polyethylene with 20`
Lip & Rim 32 Group 2;
26. Catalog No. 1115-80-008, ACS Polyethylene with 20`
Lip & Rim 32 Group 3;
27. Catalog No. 1115-80-009, ACS Polyethylene with 20`
Lip & Rim 32 Group 4;
28. Catalog No. 1115-80-017, ACS Polyethylene with 30`
Lip 32 Group 2;
29. Catalog No. 1225-11, ACS Liner With Hylamer, 10`
Group 1 (28mm);
30. Catalog No. 1225-12, ACS Liner With Hylamer, 10`
Group 2 (32mm);
31. Catalog No. 1225-13, ACS Liner With Hylamer, 10`
Group 3 (32mm);
32 Catalog No. 1225-21, ACS Liner With Hylamer, 20`
Group 1 (28mm);
33. Catalog No. 1225-22, ACS Liner With Hylamer, 20`
Group 2 (32mm);
34. Catalog No. 1225-23, ACS Liner With Hylamer, 20`
Group 3 (32mm). Recall #Z-505/538-0.
Code: All lot numbers.
Manufacturer: Depuy, Division of Boehringer Mannheim Corporation,
Warsaw, Indiana.
Recalled by: Manufacturer, by letter February 16 and 17, 1990.
Firm-initiated recall ongoing.
-10-
Distribution: Nationwide and international.
Quantity: Firm estimates 1,000 pieces remain on market.
Reason: The inability of the device to withstand long-term
torsional forces which they may be subjected to in some
applications.
----
CORRECTION NOTE: 600 CT and 1200 CT Scanners, Recall #Z-447/448-0 which
appeared in the March 28, 1990 Enforcement Report should
read:
Reason: Noncompliance with performance standard for
x-ray products in that the test data indicated that CTDI
values published by the firm were noncompliant with the
measured values also the normalization values for changes
in the slice thickness were noncompliant.
----
Hewlett-Packard Pressure Module Model M1006A, Option CO1,
Recall #Z-464-0 which appeared in the April 18, 1990
Enforcement Report should read:
Reason: A hardware defect causes a shift in analog output
that synchronizes the balloon pump, the numeric display or
recorded waves. IBAP (Intra-Aortic Balloon Pump) timeing-
synchronization is not affected.
----
Class III -
Product: Medtronic Model 9444 Teletrace II ECG Transtelephonic
Monitoring System. Recall #Z-496-0.
Code: Serial numbers XL0000145R through XL0000159R.
Manufacturer: Medtronic, Inc., Milacca, Minnesota.
Recalled by: Medtronic, Inc., Minneapolis, Minnesota, by letter March 1,
1990. Firm-initiated recall ongoing.
Distribution: Virginia, Maine, New Hampshire, Florida, Illinois,
Nebraska, Wisconsin, Arkansas, Michigan.
Quantity: 11 units were distributed.
Reason: The device may inappropriately display false pacing
artifacts caused by a temperature sensitivity of one
integrated circuit.
----
Product: Insall/Burstain II Modular Knee System Tibial Articular
Surface, size 59, 15 mm height, UHMUPE Posterior
Stabilized II, Catalog #5220-32-04. Recall #Z-498-0.
Code: Lot #66128900.
Manufacturer: Zimmer Inc., Warsaw, Indiana.
-11-
Recalled by: Manufacturer, by letter and by telephone February 15, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, England.
Quantity: 42 units were distributed.
Reason: The groove that locks the part in place in the bottom of
the UHMUPE tibial component may be mispositioned.
----
VETERINARY PRODUCTS
NONE
Prosecution Actions Filed:
Against: Maroun Brothers Inc., and Alfred G. Maroun, Treasurer
and Principal Operating Officer, Lawrence, Massachusetts.
Product: Various Foods (including flour) (89-568-124).
Charge: Products were held under insanitary conditions whereby
they may have become contaminated with filth.
Filed: February 12, 1990 - U.S. District Court for the
District of Massachusetts; Criminal #CR90-10027-T,
FDC #65707.
----
Injunction Action Filed:
Against: Cono-Mac Inc., doing business as J & K Industries and
Clifford R. Mackey, President, Claremore, Oklahoma.
Product: Snake Doctor Stun Gun (89-520-537).
Charge: Misbranded and adulterated medical device.
Filed: November 5, 1989 - U.S. District Court for the Northern
District of Oklahoma; Civil #90-C-0010E, INJ #1220.
----
Seizure Actions Filed:
Product: Various Food Items (90-504-569)
Charge: Products were shipped in unrefrigerated truck containing
frozen and non-frozen items. Hazardous containers of
chemicals, some of which were leaking, were stored on and
around the food products.
Firm: Gulf Marine & Industrial Supply, New Orleans, Louisiana.
Filed: January 26, 1990 - U.S. District Court for the Eastern
District of Louisiana; Civil #900867, FDC #65827.
----
-12-
Product: Nystatin Powder (89-542-881).
Charge: Subpotent.
Firm: Paddock Laboratories, Inc., Minneapolis, Minnesota.
Filed: February 6, 1990 - U.S. District Court for the District
of Minnesota; Civil #6-90-66, FDC #65803.
----
Product: Cardiac (Balloon) Dilatation Catheters (90-564-585).
Charge: Methods used in, and the facilities and controls used
for manufacture, packing and storage of the device were
not in conformity with good manufacturing practices (GMP's)
for medical devices.
Firm: C.R. Bard Inc., USCI Division, Billerica and Haverhill,
Massachusetts.
Filed: February 21, 1990 - U.S. District Court for the District
of Massachusetts; Civil #90-10417-WF, FDC #65815.
----
Product Kilit Biological Indicators Ampules (89-585-015).
Charge: Methods used in, and facilities and controls used for
their manufacturing, packing and storage are not in
conformity with good manufacturing practices (GMP's) for
medical devices.
Firm: Becton Dickinson Microbiological Systems, Cockeysville,
Maryland.
Filed: March 19, 1990 - U.S. District Court for the District
of Maryland; FDC #65825.
----
Product: Latex Surgical Gloves (89-425-534/89-425-533).
Charge: Adulterated - Product contains excessive holes.
Firm: Doc Surgical Supply, Englewood, New Jersey;
Filed: February 26, 1990 - U.S. District Court for the Central
District of California; Civil #90-0962/90-0963;
FDC #65828/65829.
----
Product: Jasmine Rice/Long Grain Enriched Rice (90-600-177).
Charge: Adulterated - Product contains rodent filth.
Firm: Hank Lee and Company, Brooklyn, New York.
Filed: March 14, 1990 - U.S. District Court for the Eastern
District of New York; Civil #CV-90-0976, FDC #65826.
----
-13-
Product: Basmati Rice (90-566-971).
Charge: Adulterated - Product contains insect filth/was
held under insanitary conditions.
Firm: Main International Inc, Los Angeles, California/
House of Spices, Buena Park, California.
Filed: March 29, 1990 - U.S. District Court for the Central
District of California; Civil #90-1474; FDC #65836/65837.
----
Product: 150 mg Zantac Tablets (89-459-918).
Charge: Counterfeit.
Firm: World Medical and Surgical Supply Corp., Flushing, New York.
Filed: April 12, 1990 - U.S. District Court for the Eastern
District of New York; Civil #CV-90-1262; FDC #65749.