FDA

Enforcement Report

CODE
Best if eaten by 12/1/98.

MANUFACTURER
Slovenski Medovnicky, Bratislava, Republic of Slavakia.

RECALLED BY
International Sweets, Inc., doing business as Gretel's Gingerbread Kitchen, Bristow, Virginia, by press release and by closing the push cart on September 10, 1998, and placing a sign on the cart advising of the label omission. Firm-initiated field correction (relabeling) ongoing.

DISTRIBUTION
Virginia by way of push cart sales.

QUANTITY
Approximately 200-300 cookies were distributed.

REASON
The product contains undeclared eggs, FD&C Yellow No. 5 and FD&C Yellow No. 6.

 PRODUCT
Orange Ring Cake, 9-inch, Ready to Sell, 28 ounces. Recall #F-002-9.

CODE
Lot number 8166 and use by date of 12/11/98.

MANUFACTURER
B.C. Bundt, Taylor, Pennsylvania.

RECALLED BY
Dawn Food Products, Inc., Jackson, Michigan, by press release on August 6, 1998, and by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
New Jersey, Rhode Island, Vermont, New York, Maine, Connecticut, Illinois, Indiana, Michigan, Pennsylvania, Maryland, Massachusetts.

QUANTITY
740 cases (6 units per case) were produced.

REASON
Product contains undeclared pecans.

CODE
Various.

MANUFACTURER
Pak Kashmir Bakery Corporation, Brooklyn, New York.

RECALLED BY
Manufacturer, by visit on April 25, 1997. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
60 cases (12 boxes per case) were distributed).

REASON
Product contains undeclared FD&C Yellow No. 5.

PRODUCT
Melon Cake, in 6 ounce flexible clear plastic containers. Recall #F-651-8.

CODE
None.

MANUFACTURER
Dragonald, Inc., New York, New York.

RECALLED BY
Manufacturer, by letter dated September 30, 1997. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
Undetermined.

REASON
Product contains undeclared FD&C Yellow No. 5 and FD&C Red No. 40.

PRODUCT
Young Coconut Candy, in 4 ounce plastic tray. Recall #F-652-8.

CODE
None.

MANUFACTURER
Sony Trading Company, Tokwawan, Kowloon, Hong Kong (exporter); Cawai Trading Company, Kowloon, Hong Kong (packer).

RECALLED BY
BCN Trading Corporation, Brooklyn, New York, by letter dated May 23, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
Florida, New York, Massachusetts, Pennsylvania, Connecticut, District of Columbia.

QUANTITY
100 cases (48 trays per case) were imported; firm estimates none remains on the market.

REASON
Product contains undeclared FD&C Yellow No. 5 and FD&C Blue No. 1 and an unidentified red ingredient.

PRODUCT
Hopia Mongo, a bean/wheat/rice cake, packaged in wax paper, 10 ounces. Recall #F-653-8.

CODE
None.

MANUFACTURER
Fung Wong Bakery, Inc., New York, New York.

RECALLED BY
Manufacturer. After being notified by the New York State Department of Agriculture and Markets by visit January 22, 1997, the firm posted a sign to advise their customers of the recall situation. Completed recall resulted from sample analysis and follow-up by NYSDAM.

DISTRIBUTION
New York.

QUANTITY
Undetermined.

REASON
Product contains undeclared FD&C Yellow No. 5.

PRODUCT
Sunshine brand cookies, packaged in 2 ounce (56g) foil laminated plastic sealed bags, 60 bags per case: a) Sunshine brand Snack Size Hydrox Creme Filled Chocolate Cookies; b) Sunshine brand Snack Size Vienna Cremes Sandwich Size Cookies. Recall #F-654/655-8.

CODE
Lot numbers: a) L11178F, L11108, L11298F; b) L11288B, L11278F, L11278E.

MANUFACTURER
Laurel Cookie Factory, London, Kentucky.

RECALLED BY
Dollar General Corporation, Scottsville, Kentucky, by voice mail on or about August 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Georgia, South Carolina, Florida.

QUANTITY
a) 276 cases; b) 183 cases were distributed.

REASON
Product is contaminated with paradichlorobenzene.

PRODUCT
Echo Farm brand Chocolate Puddings, in 16 ounce plastic container with snap-on lid. Recall #F-656-8.

CODE
SEP 24 1998 (pull date).

MANUFACTURER
Echo Farm, Inc., Hinsdale, New Hampshire.

RECALLED BY
Manufacturer, by telephone on August 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Connecticut, Massachusetts, Vermont, New Hampshire.

QUANTITY
200 16-ounce containers were distributed.

REASON
Product contains penicillin residues.

PRODUCT
URL Vitamin C 500 mg Tablets, in bottles of 100. Recall #F-657-8.

CODE
Control #1874-6921 EXP 12/00.

MANUFACTURER
Tishcon Corporation, Salisbury, Maryland.

RECALLED BY
Tishcon Corporation (Gel-Tec, Division of Tishcon), Westbury, New York, by letter faxed on May 21, 1998, and mailed on May 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Indiana, Delaware, New York.

QUANTITY
1,200 bottles were distributed.

REASON
Some bottles contain niacin 500 mg tablets.

CODE
Lot #050-8117 EXP 8/1/98 and 050-8188 EXP 8/2/98.

MANUFACTURER
Mallinckrodt, Inc., Maryland Heights, Missouri.

RECALLED BY
Manufacturer, by telephone on July 31, 1998, and by letter dated July 31, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide Canada, Mexico.

QUANTITY
85 kits were distributed; firm estimates none remains on the market.

REASON
Poor radiolabeling (70%) while the specification requires 95% minimum.

PRODUCT
Methylphenidate Hydrochloride, Rx, USP, used in the treatment of attention deficit disorder and narcolepsy: a) 5 mg in 1,000 tablet bottles; b) 10 mg, in 1,00 tablet bottles; c) 20 mg, in 100 and 1,000 tablet bottles. Recall #D-243/245-8.

CODE
Lot numbers: a) M531R05 EXP 09/00; b) M530T11 EXP 10/00; c) M532R01 EXP 09/00, P532E01 EXP 05/01.

MANUFACTURER
MD Pharmaceutical Inc., (Medeva Pharmaceuticals), Santa Ana, California.

RECALLED BY
Manufacturer, on or about September 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
MD label: Lot M532R01 - 960 bottles; Lot M531R05 1,956 bottles; Apothecon label: Lot P532E01 - 9,648 bottles; Lot M530T11 - 2,940 bottles were distributed.

REASON
Product failed content uniformity testing.

PRODUCT
Levothyroxide Sodium Tablets, 25, 50 and 300 microgram, Rx used as replacement or supplemental therapy in patients with hypothyroidism, under the Qualitest and Vintage labels. Recall #D-246-8 and D-263/264-8.

CODE
Lot numbers: 25 mcg - 036077A, EXP 12/98 50 mcg - 027027A, 027027B, 027027C, EXP 1/99 300 mcg - 017047A, EXP 3/99.

MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter dated May 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

25 mcg:   895 bottles; 
50 mcg:   557 bottles of lot 027027A, 284 bottles of lot 027027B
          and 952 bottles of lot 027027C;
300 mcg:  1,852 bottles were distributed.

REASON
Firm has no assurance Levothyroxide Sodium products will maintain potency through expiry.

UPDATE
Recall #D-219-8, Nifedipine Soft Gelatin Capsules, USP, 20 mg, in 300 capsule bottles, which appeared in the August 12, 1998 Enforcement Report should read:

CODE: Lot #7JY06L EXP 5/99.

CODE
Lot #078037A.

MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter dated April 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
2,826 bottles were distributed.

REASON
Product failed to meet dissolution specifications.

PRODUCT
Clorfed Capsules Extended Release product, each capsule contains 8 mg chlorpheniramine maleate, 125 mg pseudoephedrine hydrochloride, in 100 capsule bottles and in 2 count physician sample foil packs, Rx indicated for relief of upper respiratory tract and bronchial congestion. NDC #45985-542. Recall #D-248-8.

CODE
Lot #C66090 EXP 3/99.

MANUFACTURER
Schwarz Pharma Manufacturing, Inc., Seymour, Indiana.

RECALLED BY
Manufacturer, by letters on July 17, 1998, and on August 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, California, Florida, Indiana, Kentucky, Michigan, Mississippi, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas.

QUANTITY
3,010 bottles of 100 tablet bottles, and approximately 187,063 capsules in two count foil packs were distributed.

REASON
Product failed dissolution testing.

PRODUCT

a) Aconite and Iodine Solution (41.6%/58.4%), in 2 fluid ounce
containers
b) Parachlorophenol Camphorated, USP, (Camphor
65%/Parachlorophenol 35%), in 1 and 2 fluid ounce, and 1 gallon
containers;
c) Desensitizer (Phenol, USP 24.2%, Oil of cloves (22.8%), cassia
(5.4%), Eucalyptus (4.0%) Benzocaine, USP 2.0%, in 1 fluid ounce
container; 
d) Novo Devitalizing Paste (Arsenic Trioxide 38.4% Benzocaine
19.2%,Cresol 4.9%, Creosote 2.5%, Thymal 0.5%), in 6.2 g tube;
e) Formocresol (Cresol 48.5%, Formalin 48.5%, Glycerin 3.0%), in
1 and 2 fluid ounce containers, and in 1 gallon containers; 
f) Hemostatic Ferric Swabs, (Ferric subsulfate solution 49.96%,
Glycerin USP 49.96%, Phenol USP 0.08%), in 50 and 100 swab
bottles; 
g) Parachloprophenol, Liquefied (Parachlorophenol 97%), in 7 mL
and 1 gallon bottles; 
h) Perio-Eze 20 (Benzocaine 20%) in 30 g (paste) tubes; 
i) Phenol Compound (Phenol 67.5%, Thymol 16.7% Menthol 8.3) in 1
fluid ounce bottles;
j) Silver Nitrate Ammoniacal (Silver nitrate/Stronger
Ammonia/Water), in 0.5 ounce bottle; 
k) Soc-Eze (Blu Pak/Chlorobutanol 4.0%, Balsam Peru 46.0%,
Eugenol 46.0%, Benzocaine 4.0%), in 0.5 fluid ounce bottles; 
l) Iodoform Aromatic Paste (Zinc Oxide 31.31%, Iodoform 15.78%),
in 8 g paste; 
m) Gysi's Trio Paste (Barium Sulfate 31.2%, Zinc Oxide 10.2%,
Cresol 6.6%), in 11 g paste;
n) Mummifying Paste (Paraformadehyde 3.0%, Thymol 3.0%), in 6 g
paste.  Recall #D-249/262-8.

CODE
All lots manufactured at the York, PA facility:

MANUFACTURER
Moyco Technologies, Inc., York, Pennsylvania.

RECALLED BY
Manufacturer, by letter dated May 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Undetermined.

REASON
Current good manufacturing practice deviations.

CODE
Unit numbers: P24835, P24836, P24837, P24838, P24841, P24842, P24843, P24844.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter dated March 27, 1996. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
8 units were distributed.

REASON
Blood products were incorrectly tested for the Hepatitis B Surface Antigen, (HBsAg).

PRODUCT
Red Blood Cells. Recall #B-1595-8.

CODE
Unit #00-80344.

MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, Michigan.

RECALLED BY
Manufacturer, by telephone on or about February 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that compromises the sterility of the unit.

PRODUCT
a) Red Blood Cells; b) Platelets, Pheresis; c) Recovered Plasma. Recall #B-1540/1542-8.

CODE
Unit numbers: a) 53GQ61661, 53FF37264, 53FF39198; b) 53LF49137; c) 53GQ61661, 53FF37264, 53FF39198.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated June 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland and District of Columbia.

QUANTITY
a) 3 units; b) 1 unit; c) 3 units were distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested reactive for the antibody.

PRODUCT
Red Blood Cells. Recall #B-1599-8.

CODE
Unit #033LE72937.

MANUFACTURER
American Red Cross - National Testing Laboratory, Dedham, Massachusetts (testing laboratory).

RECALLED BY
American Red Cross Blood Services, Farmington, Connecticut, by telephone on August 18, 1997, and by letter dated August 20, 1997. Firm-initiated recall complete.

DISTRIBUTION
Connecticut.

QUANTITY
1 unit was distributed.

REASON
Blood product was not tested in accordance with the manufacturers instructions for either HBsAg or anti-HTLV-1.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1601/1602-8.

CODE
Unit #Z14644.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter dated September 29, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor whose donor history screening was incomplete.

PRODUCT
Platelets, Pheresis. Recall #B-1606-8.

CODE
Unit #9124311.

MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by telephone on July 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
1 unit was distributed.

REASON
Blood product tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc).

PRODUCT
a) Red Blood Cells; b) Platelets; c) Platelets for Further Manufacture; d) Recovered Plasma. Recall #B-1607/1610-8.

CODE
Unit numbers: a) 2726682, 4540357, 2872478; b) 2726682; c) 2872478; d) 4540357, 2872478.

MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by letter on June 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana, New Jersey, Switzerland.

QUANTITY
3 units; b) 1 unit; c) 1 unit; d) 2 units were distributed.

REASON
Blood products were collected from a donor taking the drug Methotrexate.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1611/1612-8.

CODE
Unit #G19983.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter dated August 21, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor whose suitability was not adequately determined.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-1613/1614-8.

CODE
Unit numbers: a) 2004942; b) 2198613.

MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by telephone on July 15 and 31, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
1 unit of each component was distributed.

REASON
Autologous use only blood products were labeled and distributed for homologous use.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma, Frozen. Recall #B-1615/1617-8.

CODE
Unit #1040347.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by letter dated January 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of jaundice.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1618/1619-8.

CODE
Unit #49LG28269.

MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.

RECALLED BY
Manufacturer, by letter dated August 3, 1998, and by fax on August 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of cancer.

PRODUCT
a) ANA-SAL HIV 1+2 Saliva test kits (Version 2) b) ANA-SAL HIV 1+2 & Type O Saliva test kits HIV-2 (Version 3). Recall #B-1620/1621-8.

CODE
Kits may have an expiration date of 2/28/97.

MANUFACTURER
Americare Biologicals, Inc., Miami, Florida.

RECALLED BY
Manufacturer, by letter dated June 2, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Florida, Illinois, Nevada, New York and international.

QUANTITY
a) Approximately 94 kits; b) approximately 6 kits were distributed.

REASON
Unapproved HIV saliva test kits, that contain non functional components, were distributed for promotional/display use without labeling indicating that they should not be used for HIV testing.

PRODUCT
Sunquest Blood Bank and Blood Donor System Computer Software Program. Recall #B-1622-8.

CODE
All copies of Sunquest Blood Bank Modules Version 5.1, 5.2 & 5.22.

MANUFACTURER
Sunquest Information Systems, Tucson, Arizona.

RECALLED BY
Manufacturer, by fax on August 7, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide, Canada, Saudi Arabia, Great Britain, Ireland.

QUANTITY
343 Sunquest clients have this product.

REASON
Computer software contains programing errors which could potentially result in the release of unacceptable test results for blood products.

PRODUCT
Source Plasma. Recall #B-1623-8.

CODE
Unit numbers: G45369-031, G45578-031, G46032-031, G46243-031, G46509-031, G46786-031, G46944-031, G47424-031, G47682-031.

MANUFACTURER
NABI BioMedical Center, San Antonio, Texas.

RECALLED BY
NABI, Boca Raton, Florida, by fax on November 25, 1995. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
9 units were distributed.

REASON
Blood products tested negative for HBsAg, but were collected from a donor who previously tested reactive for HBsAg.

PRODUCT
Red Blood Cells. Recall #B-1625-8.

CODE
Unit numbers: 34-40530, 34-40549, 36-24497, 36-24501, 36-24503, 36-24504, 36-24509, 36-24515, 36-24516, 36-24518, 38-26149, 62-33367, 62-33416, 62-33418, 62-33425, 62-33430, 62-33463, 63-05423, 63-05481, 87-08870, 87-08878, 87-08880, 87-08884, 87-08885.

MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, Michigan.

RECALLED BY
Manufacturer, by fax on June 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
24 units were distributed.

REASON
Blood products were stored at unacceptable temperatures.

CODE
Unit #E93292.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by telephone on January 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Red Blood Cells failed red cell recovery ratio.

PRODUCT
Platelets. Recall #B-1600-8.

CODE
Unit #033LJ76321.

MANUFACTURER
American Red Cross - National Testing Laboratory, Dedham, Massachusetts (testing laboratory).

RECALLED BY
American Red Cross Blood Services, Farmington, Connecticut, by telephone on August 11, 1997, and by letter dated August 13, 1997. Firm-initiated recall complete.

DISTRIBUTION
Connecticut.

QUANTITY
1 unit was distributed.

REASON
Blood product was not tested in accordance with the manufacturers instructions for either HBsAg or anti-HTLV-1.

PRODUCT
a) Platelets; b) Fresh Frozen Plasma. Recall #B-1603/1604-8.

CODE
Unit #24KJ39752.

MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.

RECALLED BY
Manufacturer, by telephone on July 30, 1998, and by letter dated August 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

QUANTITY
1 unit of each component was distributed.

REASON
Blood product was collected from a unit of whole blood with an extended collection time.

PRODUCT
Platelets. Recall #B-1605-8.

CODE
Unit numbers: 13FL79167, 13FM33271, 13FR07570, 13FY34026, 13W88442.

MANUFACTURER
American Red Cross, Detroit, Michigan.

RECALLED BY
Manufacturer, by letter dated July 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
5 units were distributed.

REASON
Platelets were not stored under continuous agitation, and stored at unmonitored temperatures.

PRODUCT
Red Blood Cells. Recall #B-1624-8.

CODE
Units 1100914 and 1100916.

MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by telephone and letter on August 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
2 units were distributed.

REASON
Blood products were exposed to unacceptable shipping temperatures.

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-1626-8.

CODE
Units numbers: 23137-5388, 23137-5668, 23137-5993.

MANUFACTURER
United Blood services, Billings, Montana.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 24, 1998, and by letter dated September 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Montana.

QUANTITY
3 units were distributed.

REASON
Blood products were stored at unacceptable temperatures.

CODE

L-Cath Procedural Trays:  Model Numbers PE-PIC-05, All tray lots
sold (first shipped 2/20/98); Model Numbers PE-NN-02, All tray
lots sold (first shipped 5/30/98);
L-Cath Peripherally Inserted Catheter Kits (with PE-PIC-05 or
PE-NN-02 Procedural Trays:
Model Numbers:  (all model numbers have the prefix PE) 16PIC60K, 
16PIC60TK, 16PIC20K, 16OIC20TK, 16PIC60DK, 16PIC60DTK, 18PIC60K,
18OIC60TK, 18PIC20K, 18PIC20TK, 18PIC60DK, 18PIC60DTK,
18PIC60STK, 20PIC60K, 20PIC20K, 20PIC60TK, 20PIC20TK, 20PIC60DK,
20PIC60DTK, 3FPIC60TK, 3FPIC20TK, (all kits lots beginning with
LMP 4828, first shipped 2/17/98); 23PIC30SK, 23PIC30STK, 24PC8TK,
24P19K, 24P30K, 24PIC30K, 24PIC30TK, 28PIC25K, 28NN8K, 28NN14K,
28NN20K, 28NN25K, (all kit lots beginning with LMP 3251, first
shipped 6/3/96).

MANUFACTURER
Luther Medical Products, Inc., Tustin, California.

RECALLED BY
Manufacturer, by letter on June 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Israel.

QUANTITY
21,292 units were distributed.

REASON
The products are mislabeled as "Latex-Free," however, they contain dry natural rubber components that may contain natural latex proteins.

PRODUCT
Acoma Overhead Tube Support, Model A902000-9, Catalog #0041,a fully counter-balanced heavy-duty radiographic x-ray tube suspension system intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. Recall #Z-010-9.

CODE
Serial numbers 05010391001 through 050100698004, all units shipped between March 1991 and June 1998.

MANUFACTURER
Acoma Medical Imaging, Inc., Wheeling, Illinois.

RECALLED BY
Manufacturer, by sending Equipment Field Modification Bulletin No. 98-01-OTS-001, Acoma Recall #1451001-1998-00001, on 9/24/98 with a cover letter of the same date. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
628 units were distributed.

REASON
Defective welds on the end plate allow the end plate on the lower tube column on the overhead tube support to break free from the column, allowing the x-ray tube/collimator assembly to hang from the high tension/power cables.

PRODUCT
Wang/Mill-Rose Transbronchial Aspiration Needles, Model SW-121, Part Numbers: (P/N) SW-121-1 and SW-121-4, size: 21 gauge, length: 15mm, packaged within a sterile Tyvek pouch, one (1) needle per pouch [P/N SW-121-1] or four (4) needles per pouch [P/N SW-121-4], disposable, single-use needles are intended for use through a bronchoscope to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. Recall #Z-011-9.

CODE
LOT NUMBERS: 12529, 12644, 12645, 13293, 13448, 12484, 13598, 13674, 14029, 14243, and 13599.

MANUFACTURER
Mill Rose Laboratories, Inc., Mentor, Ohio.

RECALLED BY
Manufacturer, by telephone on or about September 8, 1998, followed by fax letter dated September 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
975 units were distributed.

REASON
The needle tip may separate from the sheath during a surgical operation.

PRODUCT
Kodak Diconix Printer Model No. 180si (All Serial Numbers) used With the Nellcor Puritan Bennett Adult Star Ventilator, Model Nos. 1500 and 2000. Printer is sold as an accessory and is used to record settings and patient parameters to put in patient charts. Recall #Z-033-9.

CODE
All serial numbers.

MANUFACTURER
Infrasonics, Inc., San Diego, California.

RECALLED BY
Nellcor Puritan Bennett, Carlsbad, California, by letter dated July 7, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
124 units were distributed.

REASON
Printers are not compatible with the alarm driver boards on the ventilators.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III PRODUCT
VIA Medical Glucose Calibration Kit. Recall #Z-958-8.

CODE
Catalog #GLU2, Lot numbers 9805048 and 9804125.

MANUFACTURER
VIA Medical Corporation, San Diego, California.

RECALLED BY
Manufacturer, by letter on June 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arkansas, California, Florida, Illinois, Indiana, Kansas, Oklahoma, South Carolina, Texas.

QUANTITY
570 kits were distributed.

REASON
Some of the kits contain sodium chloride instead of dextrose solution.

PRODUCT

Disposable Polypectomy Snares, Sterile, used in polypectomy
procedures to remove polyps as follows:
a) Model 4562 Crescent Loop Snare (5.0x2.5cm);
b) Model 4563 Std. Oval Loop (5.0x2.5cm);
c) Model 4567 Micro Oval Loop (2.5x1.5cm);
d) Model 4577 Micro Oval Loop (2.5x1.5cm);
e) Model 4562-OLY Crescent Loop (5.0x2.5cm);
f) Model 4563-OLY Std Oval Loop (5.0x2.5cm);
g) Model 4564-OLY Maxi Oval Loop (5.0x3.5cm);
h) Model 4565-OLY Mini Oval Loop (3.5x2.0cm).
Recall #Z-001/008-9.

CODE

Lot numbers:  a) HO5-98-166; b) HO7-98-445;
c)HO5-98-187, HO5-98-231; d) HO5-98-232;
e) HO6-98-334, HO6-98-362, HO8-98-480;
f) HO5-98-227, HO7-98-435, HO7-98-395, HO8-98-482;
g) HO5-98-228, HO6-98-333; h) HO5-98-169, HO7-98-390
HO8-98-538.

MANUFACTURER
Hobbs Medical, Inc., Stafford Springs, Connecticut.

RECALLED BY
Manufacturer, by letter on September 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Connecticut, Florida, New Hampshire, Michigan, Montana, Iowa, Massachusetts, Texas.

QUANTITY
1,130 units were distributed.

REASON
Snare loop separates from the snare wire.

CODE
All lots produced prior to 7/20/98.

MANUFACTURER
Consolidated Nutrition, Springfield, Missouri.

RECALLED BY
Manufacturer, by telephone on July 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arkansas, Missouri, Oklahoma.

QUANTITY
1,331 50-pound bags were distributed.

REASON
Feed was formulated with bentonite, which is prohibited in carbadox feeds.

SEIZURE ACTION: PRODUCT
Veterinary drugs, prescription chemicals, active ingredients, commercially prepared finished dosage forms, and in-process products. The products are in violation of the new animal drug, adulteration, and misbranding provisions, ((DOC 98-688-688).

CHARGE
New Animal Drug - they are unapproved new animal drugs because they are not generally recognized by qualified experts as safe and effective for their intended uses; Adulterated - the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding do not conform to and are not operated and administered in conformity with GMP requirements for drugs; and Misbranded - they (prescription chemicals, active ingredients, commercially prepared finished dosage forms, and in-process products) fail to bear adequate directions for use and they are not exempt from this requirement because they are used in compounding unapproved new animal drugs.

LOCATON
Mortar & Pestle Veterinary Pharmacy, Inc., Des Moines, Iowa.

FILED
September 11, 1998 - U.S. District Court for the Southern District of Iowa, Central Division; Civil #4-98-CV-90491, FDC #67240.

SEIZED
September 14-16, 1998. Goods valued at $284,814.

END OF ENFORCEMENT REPORT FOR OCTOBER 7, 1998. BLANK PAGES MAY FOLLOW.