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
02/02/1994
Recalls and Field Corrections: Foods -- Class I -- 02/02/1994
February 2, 1994 94-5
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Guacamole distributed under the following labels:
(a) Vons Chili Guacamole, in 8 ounce plastic container;
Pavilions Chili Guacamole, in 8 ounce plastic containers;
El Burrito Chili Guacamole, in 11 ounce plastic containers;
(b) Las Lomas Guacamole, in 10 ounce plastic containers;
(c) Gourmet Las Lomas Guacamole, in 10 ounce plastic
containers. Recall #F-247/249-4.
CODE 11/22/93.
MANUFACTURER El Burrito Mexican Food Products, Inc., Cit of Industry,
California.
RECALLED BY Manufacturer, by fax October 14, 1993, and by press release
October 18, 1993, followed by telephone. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 393 cases were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Cake in jars: (a) Mississippi Mud Cake, 16 ounces;
(b) Fresh Apple Cake, 16 ounces; (c) Buttermilk Pound Cake,
16 ounces. Recall #F-168/170-4.
CODE None.
MANUFACTURER Glynora Enterprises, Inc., Hendersonville, Tennessee.
RECALLED BY Manufacturer, by visit or telephone or letter. Firm-
initiated recall complete.
DISTRIBUTION Arkansas, Florida, Kentucky, North Carolina, Tennessee.
QUANTITY 300 to 400 cakes were distributed.
REASON Cakes would support the growth of Stalphylococcus.
_______________
PRODUCT Pasta products packed in unlabeled plastic bags placed in
corrugated cartons for institutional/restaurant use:
1. Egg Angel Hair
2. Egg Fettucine
3. Egg Linguine
4. Egg Sheets
5. Egg Spaghetti
6. Spinach Angel Hair
7. Spinach Fettucine
8. Spinach Linguine
9. Spinach Sheets
10. Basil Fettucine
11. Basil Linguine
12. Hot Pepper Angel Hair
13. Hot Pepper Fettucine
14. Hot Pepper Linguine
15. Red Pepper Angel Hair
16. Red Pepper Fettucine
17. Red Pepper Linguine
18. Red Pepper Sheets
19. Whole Wheat Angel Hair
20. Whole Wheat Fettucine
21. Whole Wheat Linguine
22. Black Pepper Angel Hair
23. Black Pepper Fettucine
24. Black Pepper Linguine
25. Black Pepper Sheets
26. Straw & Hay Linguine
27. Saffron Fettucine
28. Saffron Linguine
29. Saffron & Squid Ink Linguine
30. Squid Ink Angel Hair
31. Squid Ink Linguine
32. Confetti Angel Hair
33. Confetti Linguine
34. 4 Cheese Tortellini
35. 4 Cheese Tri Color Tortellilni
36. Herb Tortelloni
37. Gialli Tortelloni
38. Asiago & Green Peppercorn Tortelloni
39. Tuscany Tortelloni
40. Fontina & Hazelnut Tortelloni
41. Cheese Agnolotti
42. Pesto Cheese Agnolotti
43. Black Pepper Goat Cheese Agnolotti
44. Porccini Mushroom Agnolotti
45. Spinach Agnolotti
46. Cheese Ravioletti
47. Sundried Tomato Ravioletti
48. Lobster Ravioli
49. Lobster Ravioli White Pasta
50. Basil & Ricotta Ravioli
51. Asparagus Ravioli
52. Classic Cheese Ravioli
53. Sicilian Artichoke Ravioli
54. Gorgonzola & Walnut Ravioli
55. Wild Mushroom Ravioli
56. Wild Mushroom Raviolini
57. Chevre Goat Cheese Ravioli
58. Garden Spinach Ravioli
59. Spinach Ravioli with Spinach Pasta
60. Mediterranean Eggplant Ravioli
61. Tortelloni Verde
62. Santa Fe Ravioli
63. Zucca Ravioli
64. Roasted Pepper & Smoked Mozzarella Ravioli
65. Mascarpone Ravioli. Recall #F-177/241-4.
CODE All date codes below 0356.
MANUFACTURER Nuovo Pasta Products, Ltd., Fairfield, Connecticut.
RECALLED BY Manufacturer, by letter dated December 24, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Products are contaminated with Staphylococcus aureus.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Autumn Apple brand Pasteurized Apple Cider, in 1 gallon
plastic jugs. Recall #F-242-4.
CODE All sell by dates up to and including 01/14/94.
MANUFACTURER M.H. Zeigler & Sons, Inc., Lansdale, Pennsylvania.
RECALLED BY Manufacturer, by telephone December 9, 1993, followed by
visit. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Florida, New Jersey, Delaware, New York.
QUANTITY 4,815 cases (4 jugs per case) were distributed.
REASON Product contains undeclared potassium sorbate.
_______________
PRODUCT King Kullen brand Tuna Fish, in 6-1/8 ounce cans:
(a) Solid White in Water; (b) Solid White in Oil;
(c) Chunk Light in Water; (d) Chunk Light in Oil.
Recall #F-243/246-4.
CODE (a) SASIC F148B, (b) SAOIB F145B; (c) KBSSB F146B; (d) CBOXA
F146B.
MANUFACTURER StarKist Caribe, Inc., Mayaguez, Puerto Rico
(canner/supplier).
RECALLED BY King Kullen Grocery Company, Inc., Westbury, New York, by
memorandum December 27, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY (a) 392 cases (48 cans per case); (b) 196 cases (48 cans per
case); (c) 490 cases (48 cans per case); (d) 196 cases (48
cans per case) were distributed; firm estimates very little
product remains on the market.
REASON Product is short weight (average weight was less than the
minimum value specified).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
==========================
_______________
PRODUCT Albuterol Sulfate Inhalation Solution, 0.5%, 20 ml vial with
calibrated dropper, Rx bronchodilator under the following
labels: Copley, Aligen, Astra, Geneva, Goldline, Major,
H.L. Moore, Qualitest, Rugby, Schein. Recall #D-107-4.
CODE All lots.
MANUFACTURER Copley Pharmaceutical, Inc., Canton, Massachusetts.
RECALLED BY Manufacturer, by letters of December 30, 1993, and January
6, 1994, and by press release January 5, 1994. Firm-
initiated recall ongoing. See also FDA talk papers T94-4,
January 6, 1994 and T94-5, January 7, 1994.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Approximately 4,000,000 units were distributed; firm
estimates 50 percent remains on the market.
REASON Presence of pseudomonas bacteria in some lots.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II -------------------------
_______________
PRODUCT (a) Compressed Medical Oxygen, in C, D, E and M size
cylinders; (b) Liquid Medical Oxygen in cryogenic vessels.
Recall #D-110/111-4.
CODE All fill dates.
MANUFACTURER Better Breathing Respiratory Care, Inc., Lynbrook, New York.
RECALLED BY Manufacturer, by visit. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY (a) 54 cylinders; (b) 15 units were distributed.
REASON Current good manufacturing practice deficiencies.
______________
PRODUCT Transfilled Compressed Medical Oxygen. Recall #D-112-4.
CODE All fill dates.
MANUFACTURER Lewin Agency, Inc., doing business as Lewin Medical Supply,
Riverhead, New York.
RECALLED BY Manufacturer, by visit on or about January 24, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 25 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
________________
PRODUCT Bacitracin Ophthalmic Ointment, in 3.5 g tubes and 500
bacitracin USP, Rx, marketed and packaged under the
following labels: Ocusoft, Major, Rugby, Goldline, Schein,
Medical Ophthalmics, Qualitest, Bausch and Lomb.
Recall #D-115-4.
CODE Lot numbers: 0458, 0529, 0754, 0762, 0821, 0866, 0899,
0913, 0988, 1019, 1091, 1163, 1223, 1265, 1294, 1327, 1349.
MANUFACTURER Pharmafair, Inc., Hauppauge, New York.
RECALLED BY Bausch and Lomb Pharmaceuticals, Inc., Tampa, Florida, by
letter December 16, 1993, followed by telephone. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 310,884 tubes were distributed; firm estiamtes 46,000 remain
on the market.
REASON Potency not assured through expiration date.
_______________
PRODUCT Proparacaine Hydrochloride, sterile ophthalmic solution USP,
Rx, .5%, 2 ml and 15 ml sizes, under the following labels:
Bausch and Lomb, Coopervision, Spectrum, Ocusoft, Eye
Supply, Schein, IDE, Medical Ophthalmics, Pharmascience,
Provet, Richmond, VEDCO, Wilson, Butler, Rugby, H.L. Moore,
and Akorn. Recall #D-116-4.
CODE All lots.
MANUFACTURER Pharmafair, Inc., Hauppauge, New York.
RECALLED BY Bausch and Lomb Pharmaceuticals, Tampa, Florida, by letter
December 16, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 163,108 bottles of the 2 ml size and 368,956 bottles of the
15 ml size were distributed.
REASON Potency not assured through expiration date.
_______________
PRODUCT: Indomethacin Sustained Release Capsules, 75 mg; Rx oral
anti-inflammatory used to treat moderate to severe
rheumatoid arthritis and osteoarthritis, in bottles of 30,
7, 14, 20, 100, and 60. Recall #D-117-4.
CODE Lot numbers: 3054112, 3062108, 3069084, 3090005 (30's);
3264054, 3029085, 3229008, 3232015, 3242045, 3260145,
3251067 (7's); 3005187, 3028004, 3012039, 3031088, 3046105,
3076109, 3120088, 3224088, 3246054, 3266084 (14's); 3008027,
3005197, 3029086, 3229100, 3244062 (20's); 3060034 (100's);
#3068094, 3111045 (60's).
MANUFACTURER Inwood Laboratories, Inc., Inwood, New York.
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by letters dated January 7, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 88 bottles of 30, 92 bottles of 7, 1069 bottles of 14, 190
bottles of 20, 1 bottle of 100, and 5 bottles of 60 capsules
were distributed, with the firm estimating that 25% of the
product remains on the market.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Ergoloid Mesylates Tablets, Rx, used for the symptomatic
relief of idiopathic decline in mental capacity, packed in
bottles of 100, 500 and 1,000: (a) 0.5 mg (sublingual);
(b) 1 mg (sublingual); 1 mg (oral), under the following
labels: Danbury, Schein, Qualitest, URL, Major, Martec,
Rugby, Goldline, Aligen. Recall #D-118/120-4.
CODE All lots within its expiration date. This involves 96 lots
manufactured and distributed since December 1991.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Danbury Pharmacal, Inc., Brewster, New York, by letters of
January 5 and 6, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 400,000 bottles of all sizes were distributed;
firm estimates 24,000 bottles of all sizes remain on the
market.
REASON Products do not meet USP content uniformity specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Fisons brand Delsym, 1/2 fluid ounce, nonprescription, a
controlled release dextromethorphan polistirex suspension
for 12 hour cough relief, professional sample.
Recall #D-113-4.
CODE R0230 EXP 3/94, R0431 EXP 3/94, R0432 EXP 3/94, T0076 EXP
4/94.
MANUFACTURER Fisons Corporation, Rochester, New York.
RECALLED BY Manufacturer, by voice mail on November 13, 1993, followed
by letter November 23, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY R0230 --223,768 bottles were distributed
R0431 --225,254 bottles were distributed
R0432 --222,864 bottles were distributed
T0076 --220,793 distributed were distributed
REASON Potency not assured through expiration date.
_______________
PRODUCT Hydrogen Peroxide Solution USP Topical Anti-Infective, 16
fluid ounce under the following labels: Publix, Duane
Reade, and Schwegmann Giant Super Markets.
Recall #D-114-4.
CODE Lot #0981.
MANUFACTURER Diamond Products, Seffner, Florida.
RECALLED BY Manufacturer, by telephone August 9, 1993, followed by
letter August 10, 1993. Firm-initiated recall complete.
DISTRIBUTION Florida, Louisiana, New York.
QUANTITY 1,003 cases (12 bottles per case), Publix label; 407 cases
(12 bottles per case) Schwegmann label; and 1,241 cases (12
bottles per case) Giant Super Markets label were
distributed.
REASON Superpotency.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-093/095-4.
CODE Unit numbers: 04GF83963, 04GF93584
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone and letters on December 5, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION Maine, Massachusetts, Illinois.
QUANTITY 2 units of each component.
REASON Blood products which were non-reactive for Hepatitis B
surface Antigen (HBsAg), but collected from a donor who
previously tested repeatedly reactive for HBsAg were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-111-4.
CODE Unit #20GG37874.
MANUFACTURER American Red Cross Blood Services, Boise, Idaho.
RECALLED BY Manufacturer, by telephone April 3, 1992, followed by letter
dated April 10, 1992. Firm-initiated recall complete.
DISTRIBUTION Idaho.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had visited an
area designated as endemic for malaria, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-128/130-4.
CODE Unit #22049-2427.
MANUFACTURER United Blood Services Blood System, Inc., Las Vegas, Nevada.
RECALLED BY United Blood Services Blood Systems, Inc., Scottsdale,
Arizona by letter December 2, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nevada.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who received human
pituitary-derived growth hormone, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-131-4.
CODE Unit #8937143.
MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson,
Tennessee.
RECALLED BY Manufacturer, by telephone November 22, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
was collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, was distributed.
_______________
PRODUCT Whole Blood. Recall #B-132-4.
CODE Unit AT5289.
MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, Alaska.
RECALLED BY Manufacturer, by telephone December 17, 1992. Firm-
initiated recall complete.
DISTRIBUTION Alaska.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for the
antibody to hepatitis B core antigen (anti-HBc), was
distributed.
_______________
PRODUCT Microplate Assay Management Software. Recall #B-134-4.
CODE MAS 4.50.
MANUFACTURER Genetic Systems Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by telephone November 1 and 4, 1993. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide, Australia, Brazil, France.
QUANTITY 53 copies.
REASON Computer software, which could cause the assignment of
incorrect sample identification numbers, was distributed.
_______________
PRODUCT Platelets. Recall #B-135-4.
CODE Unit #7518046.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by telephone September 25, 1991. Firm-
initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product labeled with the incorrect expiration date was
distributed.
_______________
PRODUCT Source Plasma. Recall #B-137-4.
CODE Unit #19075004.
MANUFACTURER North American Biologicals, Inc., Manhattan, Kansas.
RECALLED BY Manufacturer, by Fax January 16, 1993. Firm-initiated
recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for the
antibody to the human immunodeficiency virus (anti-HIV)m was
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-136-4.
CODE Unit #4OGT01815.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone October 4, 1993, followed by
letter October 15, 1993. Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit.
REASON Blood product labeled with an incorrect expiration date was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Deknatel Soft Toracic Catheter. Recall #Z-180-4.
CODE Product Code DSTC-28S, lot numbers: 02630, 02663, 02695,
02752, 02784.
MANUFACTURER Mallinkrodt Anesthesiology, Argyle, New York.
RECALLED BY Deknatel, Inc., Fall River, Massachusetts, by letter
September 20, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Peru.
QUANTITY 4,506 units were distributed.
REASON The blue tip of the catheter may separate or fall off during
use.
_______________
PRODUCT Sterile Laparotomy Sponges, packaged 5 per unit; products in
the 400 series contain 200 sponges per case and products in
the 300 series contain 100 sponges per case, distributed
under various labels:
(a) 18" X 18" Lap Sponges:
MAI Reorder Nos. 300, 300NB, 302, 304, 400, 400-3, 401,
401-M, 402, 402-M, 403, 404, 404-S1;
Baxter Healthcare Cat. Nos. 23250-300, 23250-302, 23250-400,
23250-402, 23250-403, 23250-404;
Voluntary Hospitals of America (VHA) Reorder No. V300, V400;
Johnson & Johnson Medical, Inc., Reorder Nos. 2563, 2567;
(b) - 4" X 18" Lap Sponges:
MAI Reorder Nos. 307, 405, 405-S1, 406, 407, 408, 408-M;
Baxter Healthcare Cat. Nos. 23250-307, 23250-405, 23250-407,
23250-408;
Johnson & Johnson Medical, Inc. Reorder Nos. 2564, 2568;
(c) - 12" X 12" Lap Sponges:
MAI Reorder Nos. 311, 409, 411. 411NL, 412, 412-M;
Baxter Healthcare Cat. Nos. 23250-311, 23250-409, 23250-411;
Johnson & Johnson Medical, Inc. Reorder Nos. 2562, 2566;
(d) 8" X 36" Lap Sponges:
MAI Reorder No. 319, 320, 417, 418, 419, 419NL, 420, 420-M;
Baxter Healthcare Cat. Nos. 23250-319, 23250-419;
Johnson & Johnson Medical, Inc. Reorder 2569;
(e) 18" X 36" Lap Sponges: MAI Reorder No. 422;
(f) 8" X 108" Lap Sponges: MAI Reorder No. 427;
(g) 17" X 26" Lap Sponges: MAI Reorder No. 426.
Recall #Z-193/199-4.
CODE Lots 100 through 1434.
MANUFACTURER South Mountain Medical Inc., Asheville, North Carolina.
RECALLED BY Medical Action Industries, Inc., Hauppauge, New York, by,
letter September 9, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 630,000 cases were distributed; firm estimated
that 35,000 cases remained on the market at time of recall.
REASON Some of the laparotomy sponges were found to be nonsterile.
_______________
PRODUCT Software for the Q-Cath Cardiac Catherization Lab Recording
System which monitors, records, and analyzes physiological
signals from patient undergoing a cardia catherization
procedure. Recall #Z-190-4.
CODE All units with a serial numbers below 662.
MANUFACTURER Quinton Instrument Company, Seattle, Washington.
RECALLED BY Manufacturer, by letter on or about August 15, 1992. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 450 units.
REASON A software error may allow electrical noise to be perceived
as a pressure trace, and consequently cause erroneous
calculations for Diastolic Filling Period, Valve Area and
Valve Flow patient parameters.
_______________
UPDATE FDA Enforcement Report dated December 22, 1993, listed two
ongoing Valleylab recalls:
Regarding Recall #Z-150/151-4, Retractable Laparoscope
Elecltrodes Series E2787R and E2788R, the report indicated
that the product was distributed in Switzerland. This is
incorrect. The entry should have been Sweden.
Regarding Recall #Z-152-4, Adult REM PolyHesive II
Disposable Patient Return Electrode, the report indicated
that the product contained within "may be Model E5706".
This is incorrect. The Model should have been "E7506".
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Cidex Activated Dialdehyde Solutions for complete
sterilization or disinfection of medical instruments and
equipment:
(a) Cidex 7 Long Life Activated Dialdehyde Solution;
(b) Cidex Plus 28 Day Solution;
(c) Cidex Activated Dialdehyde Solution.
Recall #Z-181/183-4.
CODE Gallons Quarts
(a) 2250 2245
(b) 2750 2745 & 2783
(c) 2785 2786 & 2683.
MANUFACTURER Arbrook Manufacturing Corporation, San German, Puerto Rico.
RECALLED BY Johnson & Johnson Medical, Inc., Arlington, Texas, by letter
dated August 20, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 500,600 bottles of various Cidex solutions were distributed.
REASON The devices had mismatched front and back labels. The back
label instructions for one product/code were placed on the
container with different coded front label.
_______________
PRODUCT Express Vinyl Polysiloxane Impression Material.
(a) Express Vinyl Polysiloxane Impression Material Kit,
Product #7300H, Batch #3AD1X166;
(b) Express Vinyl Polysiloxane Impression Material Light
Body, Product #7302H, Batch #3AD1X166 & #3AD2X167;
(c) Express Vinyl Polysiloxane Impression Material Regular
Body, Product #7322H, Batch #3AD1X121. Recall #Z-185/187-4.
CODE Catalog Nos. Batch Nos. Packout Day
7302H 3ADX166 19930210, 19930211,
199302151
3A2X167 19930218, 19930222,
19930223, 19930224
7322H 3AD1X121 19930215
7300H 3AD1X166 19930226, 19930227,
19930301, 19930308,
19930401, 19930402
MANUFACTURER 3M Dental Products Division, Irvine, California.
RECALLED BY 3M Dental Products Division, St. Paul, Minnesota, by letter
October 25, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Australia, Canada, Japan, Korea, Mexico,
Singapore, Thailand, United Arab Emirates.
QUANTITY (a) 8,388 kits; (b) 4,440 kits; (c) 1,279 kits.
REASON The labels indicate an insufficient set time for the dental
impression materials.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS I
=====================
_______________
PRODUCT Horse and Pony Feed, and Champ Horse Pellets, non-medicated,
in 50 pound bags. Recall #V-029/030-4.
CODE Dates of production: 7/13/93, 7/22/93, 7/28/93, 7/29/93,
8/5/93, 8/19/93, 9/1/93, 9/2/93.
MANUFACTURER Molinos de Puerto Rico, Inc., Guaynabo, Puerto Rico.
RECALLED BY Manufacturer, by visit September 28, 1993. Firm-initiated
recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 972 bags were distributed.
REASON Potential for contamination of horse feed with Monensin
(drug toxic to horses).
-12-
END OF ENFORCEMENT REPORT FOR FEBRUARY 2, 1994. BLANK PAGES MAY
FOLLOW.
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