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
04/21/1993

Recalls and Field Corrections: Foods -- Class II -- 04/21/1993

APRIL 21, 1993

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________
PRODUCT Various flavors of Atwood & Cooke brand peanut butter:
(a) Creamy Style, 16 ounces;
(b) Banana Crunch, 7.5 ounces;
(c) Chocolate Raspberry, 7.5 ounces;
(d) Chocolate Strawberry, 7.5 ounces;
(e) Chocolate Peanut Butter, 7.5 ounces.
Recall #F-135/139-3.
CODE All lots made from creamy peanut butter imported from
Argentina with Batch #5064/2.
MANUFACTURER Tomeko Corporation, Princeton, New Jersey (importer).
RECALLED BY Atwood Cooke Limited, Boston, Massachusetts, by letter
September 28, 1992. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Georgia, Wisconsin, New York, New Jersey,
Florida.
QUANTITY 648 cases were distributed.
REASON Products contaminated with aflatoxin.

_______________
PRODUCT Ceramic Dinnerware in two different patterns each labeled
Herend Hungary Handpainted: Yellow Dynasty Pattern;
(b) Blue Garden Pattern. Recall #F-249/250-3.
CODE (a) Heremd Hungary Handpainted 2515153;
(b) Herend Hungary Handpainted 1515 W53 H91.
MANUFACTURER Herend, Hungary.
RECALLED BY Gump's Inc., San Francisco, California, by letter dated
January 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON The product contains excessive levels of leachable lead.

_______________
PRODUCT Ebingers pastries packed in green paper boxes:
(a) Pineapple Cheesecake; (b) Lemon Roll;
(c) Lemon French Crumb Cake;
(d) Lemon Crumb Pie. Recall #F-273/276-3.
CODE None.
MANUFACTURER Ebingers Fine Bakers, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter and by visit on or about February
12, 1993. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey.
QUANTITY (a) 350 units; (b) 300 units; (c) 300 units; (d) 400 units
were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Brown's Velvet Dairy Products Lemonade Juice Drink, in 1
gallon bottles. Recall #F-285-3.
CODE Sell by dates: MAR 16, MAR 23, MAR 30, APR 06.
MANUFACTURER National Fruit Flavor Company, Inc., New Orleans
(concentrate).
RECALLED BY Brown's Velvet Dairy Products, New Orleans, Louisiana, by
letter February 4, 1993. Firm-initiated recall complete.
DISTRIBUTION Louisiana, Mississippi.
QUANTITY 7,249 bottles were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Quaker Chewy Granola Bars, Chocolate Chip, in 10 ounce
boxes. Recall #F-294-3.
CODE Package codes: 3H22B*, 3H23B*, 3H24B*, where * = 1 through
10. Shipping Case Codes: Feb2293H, Feb2393H, Feb2493H.
MANUFACTURER The Quaker Oats Company, Danville, Illinois.
RECALLED BY The Quaker Oats Company, Chicago, Illinois, by press
release March 12, 1993, followed by telephone and visits to
be completed March 26, 1993. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, California, Illinois, New York,
Massachusetts, New Jersey, Connecticut, Ohio.
QUANTITY 1,827 cases (10 bars per box, 12 boxes per case) were
distributed.
REASON Product is contaminated with metal fragments.

-2-RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________
PRODUCT Ebingers Pastries packed in green paper boxes:
(a) Cherry Cheesecake; (b) Blueberry Cheesecake.
Recall #F-277/278-3.
CODE None.
MANUFACTURER Ebingers Fine Bakers, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter and by visit on or about February
12, 1993. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey.
QUANTITY (a) 150 units; (b) 350 units were distributed.
REASON Products contains an artificial color whose presence is not
declared on the label.

_______________
PRODUCT Bottled Water:
(a) Smokey Mountain Brand Natural Spring Water, in 16 fluid
ounce, 1 gallon & 2.5 gallon containers;
(b) Red Foods brand Natural Spring Water, in 16 fluid
ounce, 1 gallon & 2.5 gallon containers;
(b) Smokey Mountain brand Premium Water, in 1 gallon
containers;
(c) Smokey Mountain brand Distilled Water, in 1 gallon &
2.5 gallon containers;
(d) Red Foods brand Distilled Water, in 1 gallon & 2.5
gallon containers. Recall #F-279/283-3.
CODE All containers bearing codes 1642 through 2742, inclusive,
and containers coded 9122, 9132, 9142, 9152, 9162, 9202,
9272 and 9292. All of these were packaged by the recalling
firm during the period of 06/12/92 through 09/30/92,
inclusive.
MANUFACTURER Smokey Mountain Premium Water, Inc., Lenoir City,
Tennessee.
RECALLED BY Manufacturer, by visit. Firm-initiated recall complete.
DISTRIBUTION Tennessee, Kentucky, Georgia.
QUANTITY Undetermined.
REASON Product is contaminated with non-fecal coliform.

_______________
PRODUCT Hain Naturals Fruitwich Fruit Bars, 9 ounces, in 3 flavors,
fig, apple raisin, and peach apricot. Recall #F-284-3.
CODE All lots.
MANUFCTURER J & J Snack Food Corporation of California, Los Angeles,
California.
RECALLED BY Hain Pure Food Company, Inc., Los Angeles, California, by
letter dated October 31, 1991. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.

-3-QUANTITY 8,120 cases (12 packages of 6) were distributed.
REASON Product is contaminated with mold.

_______________
PRODUCT Canned Mandarin Oranges, Kings Pantry Whole Segments in
light syrup, 11 ounces. Recall #F-289-3.
CODE The can codes were 3 line codes "S8" over "901104" over
"601", as an example. The top line code and bottom line
code were constant. The 24 can codes varied in the middle
line in the following ranges: 901104 through 901123 and
901208 through 901211.
MANUFACTURER Guanghi Cereal Oils & Foodstuffs Imports and Exports
Corporation, Manning Guanghi, China.
RECALLED BY C.M.G. Trading, Inc., Division of Strohmayer & Arpe, Short
Hills, New Jersey, by telephone on or before March 1, 1992,
by internal letters and bulletins March 2, 1992. Firm-
initiated recall complete.
DISTRIBUTION New York, Texas, Pennsylvania.
QUANTITY 4,776 cases (24 cans per case) were distributed; firm
estimates none remains on the market.
REASON Product is contained in detinning cans.

_______________
PRODUCT Nobility brand Mandarin Oranges, whole segments, in light
syrup. Recall #F-290-3.
CODE All lots with a "P" as the 1st character of the 1st line.
There were 7 lots distributed which contain the "P" code.
The top line codes are P31 or P35. The middle line codes
are 911106, 911107, 91108, or 911109. The bottom line code
is 601.
MANUFACTURER Product of the People's Republic of China.
RECALLED BY Mitsui Foods, Inc., Hackensack, New Jersey February 19,
1993. Firm initiated recall complete.
DISTRIBUTION New York.
QUANTITY 4,000 cases (24 cans per case) were distributed; firm
estimates none remains on the market.
REASON Product is contained in detinning cans.

_______________
PRODUCT (a) Old Family Recipe Parmesan Pepper Dressing, in 8 fluid
ounce bottles;
(b) Old Family Recipe Lite - Parmesan Pepper Dressing
Reduced Calorie, in 8 fluid ounce bottles.
Recall #F-291/292-3.
CODE All date codes prior to JUN 10 93G.
MANUFACTURER Martin Gillet and Company, Inc., Baltimore, Maryland.
RECALLED BY telephone January 7, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Virginia, Washington, D.C., California, Colorado,
Illinois, Massachusetts, New Jersey, Nebraska, Wyoming, New
York, New England.
-4-QUANTITY (a) 3,386 cases (12 bottles per case); (b) 749 cases (12
bottles per case) were distributed.
REASON Product is contaminated with yeast.

_______________
PRODUCT Cashews packed into 25 pound tins labeled as packed by M.
Abdul Rahumankunju Quilon. Recall #F-293-3.
CODE Lot #4318.
MANUFACTURER Specialty Commodities, Los Angeles, California (importer).
RECALLED BY Nutrasource, Seattle, Washington, by telephone March 3,
1993, followed by letter. Firm-initiated recall ongoing.
DISTRIBUTION Alaska, Washington state, Oregon.
QUANTITY 215 tins were distributed.
REASON Product is contaminated with insect filth.

_______________
PRODUCT Health For Life brand L-Carnitine, 250 mg caplets,
nutritional supplement. Recall #F-295-3.
CODE 2609-2.
MANUFACTURER International Vitamin Supplement, Inc., Union, New Jersey.
RECALLED BY Triage Pharmaceutical, Inc., Syracuse, New York, by fax
March 5, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,412 bottles were distributed.
REASON Product is subpotent for L-carnitine, 38% of label claim.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________
PRODUCT Bancap Capsules, (50 mg butalbital and 325 acetaminophen),
in 100 and 500 capsule bottles, Rx for the relief of the
symptoms complex of tension or muscle contraction,
headache. Recall #D-217-3.
CODE Lot #4916 EXP 5/93.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., Maryland Heights, Missouri,
by letters dated February 1, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,606 100-capsule bottles and 60 500-capsule bottles were
distributed.
REASON Unreliable data in the Abbreviated New Drug Application.

_______________
PRODUCT Ampicillin for Oral Suspension, USP, 125 mg/5 ml, 200 ml
(when mixed), Rx product used to treat infections, under
the following labels: URL, Schein, Goldline, Aligen,
Major, Rugby. Recall #D-218-3.
CODE Lot #27871 EXP 3/1/94.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey.

-5-RECALLED BY Biocraft Laboratories, Inc., Fairlawn, New Jersey, by
telephone September 10, 1992, followed by letters of
September 14 and 22, 1992. Firm-initiated recall complete.
DISTRIBUTION New York, Wyoming, Illinois, Kentucky, California,
Pennsylvania, Florida.
QUANTITY 5,010 bottles were distributed.
REASON Subpotency.

_______________
PRODUCT E.S.P. (Erythromycin Ethylsuccinate and Sulfisoxazole
Acetyl) for oral suspension, 200 mg/600 mg/5 ml, a Rx
antibiotic powder. Recall #D-219-3.
CODE Lot numbers: 1H445DQ EXP 9/95, 1I445EF EXP 10/95.
MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY Manufacturer, by letter on or about February 26, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Subpotency.

_______________
PRODUCT Erythromycin Lactobionate, USP Intravenous sterile,
lyophilized powder for reconstitution and injection, used
in the treatment of infections. Recall #D-228-3.
CODE Control numbers: 323-807 (2849-01-111),
307-815 (2849-02-111), 3170848 (2848-56-400).
MANUFACTURER Lederle Parenterals, Carolina, Puerto Rico.
RECALLED BY Manufacturer, by letter March 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,320 units (packages of 10) were distributed.
REASON Product fails pH and potency specifications after
reconstitution.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________
PRODUCT National Health Products Caplets/Tablets: (a) Steroid
Replacer Pacs, an OTC multi-ingredient drug product, 7
tablets wrapped in plastic bags called packets with 30
packets per retail box;
(b) Hormoplex GH, an OTC combination ingredient drug
product in plastic bottles of 90 and 180;
(c) Cleanze System, an OTC multi-ingredient drug, in paper
boxes of 6 tablets and packed in a plastic bag called
packet with 45 packets per retail box.
Recall #D-214/216-3.
CODE All codes.
MANUFACTURER (a) Energy Factors, Inc., Largo, Florida;
(b) Healthy 'N Fit International, Bronx, New York;
(c) Garden State Nutritionals, Fairfield, New Jersey.

-6-
RECALLED BY National Health Products, Orlando, Florida, by letter
February 17 and 18, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately (a) 2,000 boxes; (b) 2,000 boxes; (c) 3,000
to 4,000 boxes were distributed.
REASON Products were marketed without new drug approval.

_______________
PRODUCT Erythromycin Delayed Release Capsules, 250 mg, a Rx oral
antibiotic. Recall #D-220-3.
CODE Lot #1F584EV EXP 7/93.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter on or
about February 26, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Superpotent.

_______________
PRODUCT Erythromycin Stearate Tablets; (a) 250 mg; (b) 500 mg, in
bottles of 500, oral Rx antibiotics. Recall #D-221/222-3.
CODE Lot numbers: (a) 0I013FQ EXP 3/93; (b) 2A219HJ EXP 5/94.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter on or
about February 26, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON (a) Small degrees of subpotency.
(b) Product does not meet content uniformity
specifications.

_______________
PRODUCT Erythromycin Ethylsuccinate Tablets, 400 mg, in bottles of
100, a Rx oral antibiotic. Recall #D-223-3.
CODE Lot #0B259FA EXP 3/94.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter on or
about February 26, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product does not meet content uniformity specifications.

_______________
PRODUCT Aspirin with Codeine Tablets, 325 mg/60 mg, a Rx analgesic.
Recall #D-224-3.
CODE Lot #1C280DT EXP 1/96.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter on or
about February 26, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Subpotent.

-7-_______________
PRODUCT Hydrocodone Bitartrate with Acetaminophen Tablets, 5 mg/500
mg, in bottles of 100, 50, 20, and 30, an
antitussive/analgesic combination. Recall #D-225-3.
CODE Lot #1D325CL EXP 5/94.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter on or
about February 26, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Superpotent.

_______________
PRODUCT Meperidine HCl Tablets, 50 mg, in bottles of 100, a
narcotic analgesic. Recall #D-226-3.
CODE Lot #0B381AT EXP 3/93.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter on or
about February 26, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Subpotent.

_______________
PRODUCT Dicyclomine HCl Capsules, USP, 20 mg, in bottles of 1,000,
an antispasmodic and anticholinergic. Recall #D-227-3.
CODE Lot numbers: 0E126AA EXP 7/94 and 1H125CX EXP 9/95.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter on or
about February 26, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Small degrees of superpotency.

_______________
PRODUCT Topical Heparin Powder, in 55 gallon size fiber drums, used
to manufacture topical ointments. Recall #D-229-3.
CODE Lot numbers: TH-182-92, and TH-183-92.
MANUFACTURER Kabi Pharmacia Hepar, Inc., Franklin, Ohio.
RECALLED BY Manufacturer, by letter dated February 9, 1993. Firm-
initiated field correction ongoing.
DISTRIBUTION France.
QUANTITY 2 drums were distributed.
REASON Product mislabeled as Lithium Heparin.

RECALLS AND FIELD CORRECTIONS; BIOLOGICS -- CLASS I

_______________
PRODUCT Platelets. Recall #B-104-3.
CODE Unit #9A9293.

-8-MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone December 20, 1991. Firm-
initiated recall complete.
DISTRIBUTION Washington state.
REASON Blood product, which tested repeatedly reactive for the
antibody to the hepatitis C virus encoded antigen (anti-
HCV) by both the enzyme immunoassay (EIA) and by the
recombinant immunoblot assay (RIBA), was distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells For Further
Manufacture; (c) Recovered Plasma. Recall #B-226/228-3.
CODE Unit numbers: H28426, M34799; (b) M29306;
(c) H20104/2, H20695/2, M30597/2, M30615/2, M34799/2,
M39202/2.
MANUFACTURER Milton S. Hershey Medical Center, Hershey, Pennsylvania.
RECALLED BY Manufacturer, by letters dated November 27, 1992 and
December 14, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Maryland.
QUANTITY (a) 2 units; (b) 1 unit; (c) 6 units.
REASON Blood products, which tested negative for the antibody to
human immunodeficiency virus type 1 (anti-HIV-1) and the
antibody to hepatitis C virus encoded antigen (anti-HCV),
but were collected from donors who either: 1) previously
tested repeatedly reactive for anti-HIV-1, or 2) previously
tested repeatedly reactive for anti-HIV-1 and anti-HCV,
were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________
PRODUCT Omnitron Model 2000 High Dose Rate Remote Afterloader
System for brachytherapy radiation -- administering
radiation interstitially directly to the tumor bed of a
cancer patient. Recall #Z-169-3.
CODE Serial numbers: 105, 108, 115, 116, 123, 124.
MANUFACTURER Omitron International, Inc., Houston, Texas.
RECALLED BY Manufacturer, by letter January 14, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, Maryland, New Jersey, New York, Pennsylvania,
Tennessee.
QUANTITY 6 units were distributed.
REASON The source wires which were shipped in teflon-lined
containers and exposed to hydrogen fluoride gas may be
subject to embrittlement which would make them more likely
to break.

_______________
PRODUCT Sterile obstetrical/gynecological devices:
(a) Uter Vac Rigid Vacuum Curettes, 6 mm through 16 mm
sizes;
-9- (b) Flexible Curettes labeled as Vacuum Aspiration
Catheters, 4 mm through 8 mm sizes;
(c) Uterine Sounds, Reorder No. 0315011;
(d) Cervical Dilator sets labeled as CervEx Dilators, each
set contains 1-5 dilators, 3 mm through 16 mm;
(e) Uter Cyte Endometrial Sampling Sets;
(f) Menstrual Aspiration Sets;
(g) Uter Vac Tissue Collection Sets. Recall #Z-440/446-3.
CODE All lots.
MANUFACTURER International Medical Technologies Group Inc., Glens Falls,
New York, telephone beginning March 12, 1993, which were
completed on or about March 16, 1993, and by letters dated
March 9, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 468,553 units; (b) 11,638 units; (c) 314 kits; (d) 103
sets; (e) 2,490 units; (f) 25,326 units; (g) 2,834 units
were distributed.
REASON Products are labeled as sterile when they are not.

_______________
PRODUCT Transrectal Biopsy Guide, manual gastorenterology urology
surgical accessory device used with the advanced diagnostic
medical system style transrectal probe. Recall #Z-473-3.
CODE All lots manufactured for the last two years.
MANUFACTURER Acoustic Associates, Marietta, Georgia.
RECALLED BY Manufacturer, by letter August 17, 1992. Firm-initiated
recall complete.
DISTRIBUTION Colorado, Florida, Missouri, New York, Pennsylvania, Texas.
QUANTITY Approximately 1,000 units were distributed.
REASON Product was manufactured under a lack of good manufacturing
practices including no product specifications, no device
history, no sterilization validation, and also lacks
required labeling including product identity, description
and directions for use.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________
PRODUCT Boston Broth Culture Media for cultivation of
Mycoplasmataceae, an in-vitro diagnostic, in 2 ml capped
vials. Recall #Z-471-3.
CODE Product #S1150, lot #7583 EXP 1/14/93.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by discussing problem with both accounts on
December 10 and 21, 1992. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 379 vials were distributed; firm estimates none remains on
the market.
REASON Product may be contaminated with fuzzy mold growth.

-10-_______________
PRODUCT Tryptic Soy Agar with 0.5% Tween 80 and 0.05% Sodium
Thiosulfate (Rodac) Contact Plate, culture media used for
the detection and enumeration of microorganisms on surfaces
of sanitary importance. Recall #Z-472-3.
CODE Product #C6087 Lot #8872 EXP 5/19/93.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufcturer, by telephone March 11, 1993. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 45 cartons (10 plates per carton) were distributed; firm
estimates none remains on the market.
REASON Product may produce extremely poor/unacceptable
growth/recovery of E. coli.

_______________
PRODUCT Nellcor N-250 Pulse Oximeter/ECG Monitor Manual.
Recall #Z-474-3.
CODE All serial numbers distributed between 4/7/91 and 11/26/91.
MANUFACTURER Nellcor, Inc., Chula Vista, California.
RECALLED BY Nellcor, Inc., Hayward, California, by letter December 23,
1991, followed by telephone from January 27, 1992 through
May 28, 1992. Firm-initiated field correction complete.
DISTRIBUTION Texas and international.
QUANTITY 640 units were distributed.
REASON Manual contains incorrect information regarding attachment
of an external alarm.

_______________
UPDATE We are withdrawing Recall #Z-169-3, Invos 3100 Cerebral
Oximeter, which appeared in the January 20, 1993,
Enforcement Report, and are more appropriately classifying
the firm's action as a market withdrawal. After further
review, it appears that the devices were either used as
demonstration units or for investigational pruposes with
IRB approval.

RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS III
_______________
PRODUCT Tryptic Soy Agar with Washed Bovine Blood Cells and 0.1%
Esculin, mastitis test kit. Recall #V-025-3.
CODE Product #M1123, lot #8651 EXP 4/13/93.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois, by telephone
February 17, 1993. Firm-initiated recall complete.
DISTRIBUTION Idaho.
QUANTITY 15 cartons (10 plates per carton) were distributed; firm
estimates none remains on the market.
REASON Plates were contaminated with microorganisms.

-11-
_______________
PRODUCT Tryptic Soy Agar with Washed Bovine Blood Cells and 0.1%
Esculin, mastitis test kit. Recall #V-026-3.
CODE Product #M1123, lot #4575 EXP 5/13/92.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by telephone March 23, 1993. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin, Vermont.
QUANTITY 78 cartons (10 plates per carton) were distributed; firm
estimates none remains on the market.
REASON Plates were grossly contaminated due to contaminated blood.

SEIZURES:
_______________
PRODUCT "ATTENDS" adult protective garments for incontinence
(92-673-761).
CHARGE Adulterated - The article consists in part of a filthy
substance. Misbranded - The article is in package form and
its label fails to bear the name and place of business of
the manufacturer, packer, or distributor, and the label also
fails to bear an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical count.
FIRM Advantage Medical, Inc., Tulsa, Oklahoma.
FILED November 30, 1992; U.S. District Court for the Northern
District of Oklahoma; Civ. #92-C-1093-E; FDC #66615.
SEIZED January 21, 1993 - goods valued at approximately $12,800.

_______________
PRODUCT Dried uneviscerated fish (93-641-248).
CHARGE Adulterated - The articles have been prepared, packed, or
held under insanitary conditions whereby they may have been
rendered injurious to health.
FIRM Phil-Am Distributors, doing business as The Fish House, Long
Beach, California.
FILED March 4, 1993; U.S. district Court for the Central
District of California; Civ. #93-1280WJR(TGx); FDC #66671.
SEIZED March 24, 1993 - goods valued at approximately
$2,760.

-12-

END OF ENFORCEMENT REPORT FOR APRIL 21, 1993. BLANK PAGES MAY
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