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.

June 18, 1997 97-25

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Planters Honey Roasted Cashews, in 2 ounce
packages. Recall #F-463-7.
CODE Date Code 1-07-98.
MANUFACTURER Planters Company, Suffolk, Virginia.
RECALLED BY Nabisco, Inc., Parsippany, New Jersey, by
letters dated February 14 and 21, 1997, and by
press release on February 14, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,725 cases (12 bags per case) were distributed;
firm estimated that 2% of product remained on
market at time of recall initiation.
REASON Some packages of product were found to contain
undeclared peanuts.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Sara Lee frozen coffee cakes, cobblers, Danish
pastries, cakes and muffins in retail, food
service and bakery deli packaging as listed
below:
1. Sara Lee Pecan Coffee Cake, Net weight 11.5
oz., 8 cakes per case, Sara Lee Bakery, Chicago,
IL
2. Sara Lee Butter Streusel Coffee Cake, Net
Weight 11.5 oz., 8 cakes per case, Sara Lee
Bakery, Chicago, IL
3. Foodservice Cobbler Cherry Country Fruit
Cobbler, Net Weight. 5 lb., 2 per case (SKU
5447) and 4 per case (SKU 5433),
4. Food service Cobbler Peach Country Fruit
Cobbler with Artificial Peach Flavor, Net Weight
5 lb., 2 per case, C.P., Traverse City, MI, also
packaged under Monarch Regency Peach Cobbler
with Artificial Peach Flavor, packed for
PYA/Monarch, Inc., Greenville, SC ,
5. Food service Cobbler Blackberry Country
Fruit Cobbler, Net Weight 5 lb., 2 per case,
C.P., P.O. Box 1009, Traverse City, MI
6. Sara Lee Bakery Deli Apple Strip Danish, Net
Weight 14 oz., 12 per case, Sara Lee Bakery,
Chicago, IL, SKU 7651 - individual Danish in box
labeled Apple Danish Coffee Cake, Distributed by
Country Commons Co., Chicago, IL and SKU 7729 -
individual Danish in plastic clamshell labeled
Apple Danish, Distributed by Country Commons
Co., Chicago, IL
7. Sara Lee Bakery Apple Danish, Net Weight
3-1/4 oz., 24 individually wrapped Danish per
case, Sara Lee Bakery, Chicago, IL
8. Sara Lee Food service Apple Demi-Danish,
unwrapped individual Danish, 10 per tray, 5
trays per 3 lb. 14-1/2 oz. case, Sara Lee
Bakery, Chicago, IL
9. Sara Lee Bakery Raspberry Danish, Net Weight
3-1/4 oz., 24 individually wrapped Danish per
case, Sara Lee Bakery, Chicago, IL
10. Bakery Deli Bulk Uniced Chocolate Cupcakes,
24 cupcakes per tray, 5 trays per 8.75 lb. case,
Sara Lee Bakery, Chicago, IL
11. Sara Lee Food service Bakery Old Fashioned
Chocolate Layer Cake, Net Weight 45 oz., 4 per
case, Sara Lee Bakery, Chicago, IL
12. Sara Lee Food service Bakery Old Fashioned
Carrot Layer Cake, Net Weight 60 oz., 4 per
case, Sara Lee Bakery, Chicago, IL
13. Sara Lee Food service Carrot Iced Sheet
Cake, Net Weight 84 oz., 3 per case, Sara Lee
Bakery, Chicago, IL
14. Sara Lee Food service Old Fashioned Cake -
Round Lemon Cream Layer Cake, 4 per case, Sara
Lee Bakery, Traverse City, MI
-2- 15. Sara Lee Food service Old Fashioned Cake -
Round Coconut Layer Cake, 4 per case, Sara Lee
Bakery, Traverse City, MI
16. Sara Lee Food service Bakery Large Cheese
Streusel Muffins 12 4-1/4 oz. muffins per tray,
4 trays per case, Sara Lee Bakery, Chicago, IL
17. Sara Lee Cheese Streusel Muffin, Net Weight
4 oz., 24 individually wrapped muffins per case,
Sara Lee Bakery, Chicago, IL
18. Sara Lee Food service Banana Nut Mini
Muffins, 54 muffins per tray, 2 trays per case,
Sara Lee Bakery, Chicago, IL
19. Sara Lee Food service Bakery Banana Nut
Muffins with Artificial Banana Flavor, 12 4-1/4
oz. muffins per tray, 4 trays per case, Sara Lee
Bakery, Chicago, IL
20. Sara Lee Bakery Deli Jumbo Banana Nut
Muffins with Artificial Banana Flavor, 12 4 oz.
muffins per tray, 4 trays per case, Distributed
by Country Commons Co., Chicago, IL
21. Sara Lee Bakery Deli Blueberry Muffins with
Artificial Blueberry Flavor, 6 muffins per 16
oz. pack, 12 packs per case, Distributed by
Country Commons Co., Chicago, IL
22. Sara Lee Food service Bakery Blueberry
Muffins with Artificial Blueberry Flavor, 12
4-1/4 oz. muffins per tray, 4 trays per case,
Sara Lee Bakery, Chicago, IL
23. Sara Lee Blueberry Muffin with Artificial
Blueberry Flavor, Net Weight 4 oz., 24
individually wrapped muffins per case, Sara Lee
Bakery, Chicago, IL
24. Sara Lee Low Fat Blueberry Muffin with
Artificial Blueberry Flavor, Net Weight 4 oz.,
24 individually wrapped muffins per case, Sara
Lee Bakery, Chicago, IL
25. Sara Lee Bakery Deli Bran Muffins, 6 muffins
per 15 oz. pack, 12 packs per case, Distributed
by Country Commons Co., Chicago, IL
26. Sara Lee Food Service Bakery Bran Muffins,
24 2-1/8 oz. muffins per tray, 4 trays per case,
Sara Lee Bakery, Chicago, IL
27. Sara Lee Bakery Deli Lemon Poppyseed Mini
Muffins, 8 muffins per 6-1/2 oz. pack, 16 packs
per case, Distributed by Country Commons Co.,
Chicago, IL
28. Sara Lee Food Service Bakery Lemon
Poppyseed Mini Muffins, 54 muffins per tray, 2
trays per case, Sara Lee Bakery, Chicago, IL

-3- 29. Sara Lee Corn Muffins, Net Weight. 4-1/4
oz., 24 individually wrapped muffins per case,
Sara Lee Bakery, Chicago, IL.
Recall #F-416/444-7.
CODE 1. SKU 2340, UPC 32100-02340, lot 04086344xx
2. SKU 2342, UPC 32100-02342, lot 04086345xx,
04086346xx, 04086347xx
3. (SKU 5433), UPC 32100-05447, lot 04046344xx
4. SKU 5446, UPC 32100-05446, lot 04046345xx,
AP #0076194, SKU 9069, lot 04046345xx
5. SKU 5449, UPC 32100-05449, lot 04046346xx
6. SKU 7651, lot 04076347xx and SKU 7729,
lot 04096347xx
7. SKU 8356, UPC 32100-08356, lot 04016344xx
8. SKU 8917, lot 04096345xx
9. SKU 8355, UPC 32100-08355, lot 04016345xx
10. SKU 3938, lot 04056344xx
11. SKU 8547, UPC 32100-08547, lot 04136345xx
12. SKU 8549, UPC 32100-08549, lot 04136344xx
13. SKU 5412, lot 04056346xx
14. SKU 5388, lot 04136346xx
15. SKU 5378, lot 04136347xx
16. SKU 8643, UPC 32100-08643, lot 04046344xx
17. SKU 8649, UPC 32100-08649, lot 04016347xx
18. SKU 8821, lot 04046344xx
19. SKU 8613, UPC 32100-08613, lot 04046345xx
20. SKU 7743, UPC 32100-07743, lot 04046345xx
21. SKU 7723, UPC 32100-07723, lot 04126345xx
22. SKU 8607, UPC 32100-08607, lot 04046346xx,
04046347xx
23. SKU 8625, UPC 32100-08625, lot 04016346xx
24. SKU 8699, UPC 32100-08699, lot 04016346xx
25. SKU 7724, lot 04126345xx
26. SKU 8606, lot 04056347xx
27. SKU 7764, UPC 32100-07764, lot 04126346xx
28. SKU 8822, lot 04046346xx
29. Sara Lee Corn Muffins, Net Weight
4-1/4 oz., 24 SKU 8636, UPC 32100-08636,
lot 04016347xx.
MANUFACTURER Sara Lee Bakery, Tarboro, North Carolina.
RECALLED BY Sara Lee, Bakery, Chicago. Illinois, by fax on
February 6, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 80,557 cases were distributed; firm estimated
that 15% of the product remained on market at
time of recall initiation.
REASON The products may contain small pieces of sifter
screen wire.

-4-_______________
PRODUCT Good Day artificially flavored Orange Drink, in
1 gallon plastic containers. Recall #F-458-7.
CODE APR 02..J.
MANUFACTURER Alpenrose Dairy, Portland, Oregon.
RECALLED BY Manufacturer, by telephone on March 26, 1997,
followed by visit between March 27 and 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Washington state and Oregon.
QUANTITY 500 gallons were distributed; firm estimates
none remains on the market.
REASON Product is contaminated with yeast.

_______________
PRODUCT Ginger Ale, in 3 liter bottles under the World
Classics label. Recall #F-460-7.
CODE Production date codes 06299 and 06344.
MANUFACTURER Cott Distributors USA, Inc., Oakfield, New York.
RECALLED BY Cott Beverages USA, Inc., Columbus, Georgia, by
letter dated April 3, 1997. Ongoing recall
resulted from sample analysis and followup by
the New York State Department of Agriculture and
Markets.
DISTRIBUTION New York and Pennsylvania.
QUANTITY 1,806 cases (6 units per case) were distributed;
firm estimated little if any product remained on
market at time of recall initiation.
REASON Product contains yeast.

_______________
PRODUCT Blueberry Pie Filling in 21 ounce cans under the
Flavorrite, Fry's, Kroger, Meijer, Shurfine,
Smith, and Spartan labels. Recall #F-461-7.
CODE 24961BFF, 24962BFF, 25061BFF, 25461BFF,
25462BFF, 25561BFF, 25562BFF, and 26061BFF.
MANUFACTURER Burnette Foods, Inc., Elk Rapids, Michigan.
RECALLED BY Manufacturer, by telephone in October/November
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 250,000 cans were distributed.
REASON Product is contaminated with Byssochlamys.

_______________
PRODUCT Motts 100% Apple Juice from concentrate packaged
in 64 fluid ounce plastic bottles.
Recall #F-462-7.
CODE WP70203 - WP70204.
MANUFACTURER Motts, Inc., Williamson, New York.
RECALLED BY Mott's North America, Stamford, Connecticut, by
letter on February 13, 1997. Firm-initiated
recall ongoing.
-5-DISTRIBUTION New York, Michigan, Virginia, Minnesota.
QUANTITY 4,150 cases were distributed.
REASON Product is contaminated with yeast
(Saccharomyces cervisae).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
II ============
_______________
PRODUCT Levothyroxine Sodium Tablets, USP 0.025 mg in
bottles of 100, Rx, prescribed as a thyroid
replacement therapy, under the following labels:
MOVA, Pharmascience, Warner Chilcott, Duramed,
Major. Recall #D-186-7.
CODE Lot numbers: MNT1221A, MNT1222A, MNT1223A,
MNT1224A, MNT1225B, MNT1225C EXP 7/97.
MANUFACTURER MOVA Pharmaceutical Corporation, Caguas, Puerto
Rico.
RECALLED BY Manufacturer, by letter dated April 15, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 8,155 units were distributed.
REASON Subpotent (stability).

_______________
PRODUCT Clinda-Derm Clindamycin Phosphate Topical
Solution USP 1%, in bottles with a net content
of 60 ml, used in the treatment of acne
vulgaris. Recall #D-188-7.
CODE Lot numbers: 6B6891, 6B6892, 6D6130, 6F6289,
6H6484, 6A6485, and 6L6669. All of these lots
were distributed under the Clinda-Derm brand.
Only lot 6H6484 also included product labeled
with the h.l. Moore brand.
MANUFACTURER Paddock Laboratories, Inc., Minneapolis,
Minnesota.
RECALLED BY Manufacturer, by letter on May 16, 1997, Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 36,400 vials were distributed.
REASON Bulk Clindamycin was recalled by Roussel
Corporation (parent firm of Biochimica Opos) due
to AADA (Abbreviated Antibiotic Drug
Application) discrepancies regarding
manufacturing process.

_______________
PRODUCT Demerol (Meperidine HCl, USP) Syrup, 10 mg/ml,
in 16 ounce bottles, used for relief of moderate
to severe pain. Recall #D-190-7.
CODE Lot numbers: LB323 EXP 2/98, KK361 EXP 9/97,
LF369 EXP 6/98.
-6-MANUFACTURER Bayer Corporation, Myerstown, Pennsylvania.
RECALLED BY Sanofi Pharmaceuticals, Inc., New York, New
York, by letter dated April 23, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 22,203 units were distributed.
REASON Superpotent.

_______________
UPDATE Recall #D-174-7, Ciba Vision Ophthalmics
(Duluth, Georgia) Miochol-E (Acetylcholine
Chloride Intraocular Solution, 20 mg/2 ml vial
has been extended as follows:
CODE Lot numbers: U2291 EXP 2/98, U2291D EXP 2/98.
DISTRIBUTION Nationwide.
QUANTITY 14,508 units were distributed between November 1
and 6, 1996.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Bio-Safe Antibacterial Lotion (Triclosan 0.3%),
in 2 fluid ounce plastic bottles.
Recall #D-184-7.
CODE Lot #12 EXP 98 6887.
MANUFACTURER Stanford Personal Care Manufacturing, Saugus,
California.
RECALLED BY Bio-Safe Skin Products, Milwaukee, Oregon, by
letter dated April 14, 1997, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Hawaii, Oregon, Washington
state, Wisconsin.
QUANTITY 798 bottles were distributed.
REASON Separation of lotion.

_______________
PRODUCT Aspirin Free Excedrin Extra Strength Caplets, in
bottles of 100, OTC pain reliever.
Recall #D-185-7.
CODE Lot #EREQ6M1AV, Case Code 0893, EXP 5/99.
MANUFACTURER Bristol-Myers Products, Morrisville, North
Carolina.
RECALLED BY Bristol-Myers Products, A Bristol-Myers Squibb
Company, Hillside, New Jersey, by letter dated
January 23, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION New Jersey, Georgia, California, Illinois,
Hawaii.
QUANTITY 1,655 cases (24 bottles per case) were
distributed.

-7-REASON Labeling -- Carton incorrectly lists aspirin as
ingredient.

_______________
PRODUCT Benadryl Itch Stopping Gel, 2%, Extra Strength
in 4 ounce containers. Recall #D-187-7.
CODE Lot #'S 86826l and 86826LX as open stock items,
and the Benadryl poison ivy display lot 00836Y,
01236Y, 01336Y, and 01336YA.
Lot 86826l was packaged into 60.552 containers
each containing 4 oz. of the gel and bearing the
item code 17160. The entire lot of the 4 oz
containers was shipped to the recalling firms
customer service center to be packaged as 1,260
units of the Poison Ivy 48-Pie E Wing Unit
display and the displays were assigned lots
numbers 00836Y, 01136Y, 01236Y, and 01336YA.
Part of these displays, 134 units, were later
broken down to generate open stock items and
were assigned the lot number 86826lX. Each
individual container does however bear the lot
number 86826l.
MANUFACTURER Paco Pharmaceutical Services, Lakewood, New
Jersey.
RECALLED BY Warner-Lambert, Consumer Healthcare Division,
Morris Plains, New Jersey, by letter dated April
14, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,650 units were distributed.
REASON Product fails to meet zinc acetate content
specifications through shelf-life (stability).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT Platelets. Recall #B-628-7.
CODE Unit #S55766.
MANUFACTURER Irwin Memorial Blood Centers, San Francisco,
California.
RECALLED BY Manufacturer, by telephone on May 28, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT Source Plasma. Recall #B-649-7.
CODE Unit #70689150.
MANUFACTURER Bio-Blood Components, Inc., Gary, Indiana.

-8-RECALLED BY Manufacturer, by fax and letter on November 11,
1996. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of incarceration.

_______________
PRODUCT a) Red Blood Cells; b) Red Blood Cells -
Leukocytes Reduced; c) Platelets; d) Fresh
Frozen Plasma. Recall #B-711/714-7.
CODE Unit numbers: a) 8521398, 8462215; b) 8626609;
c) 8626609, 8521398, 8462215; d) 8521398.
MANUFACTURER Community Blood Centers of South Florida, Inc.,
Lauderhill, Florida.
RECALLED BY Manufacturer, by fax or telephone on January 15,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Florida and New York.
QUANTITY a) 2 units; b) 1 unit; c) 3 units; d) 1 unit was
distributed.
REASON Blood products were collected from a donor with
a history of receiving human pituitary-derived
growth hormone.

_______________
PRODUCT Red Blood Cells. Recall #B-861-7.
CODE Unit #24KH09152.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated April 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of cancer.

_______________
PRODUCT Recovered Plasma. Recall #B-875-7.
CODE Unit #17026-0665.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by
letter dated April 9, 1997. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had
previously self-excluded.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-877/879-7.

-9-CODE Unit numbers: a)11045-9363, 11043-3315, 11034-9969; b) 11045-9363, 11043-3315, 11034-9969; c)
11034-9969, 11043-3315.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated February 21, 1997, and May 2,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Texas, New Mexico, New York, North Carolina.
QUANTITY a) 3 units; b) 3 units; c) 2 units were
distributed.
REASON Blood products were collected from a donor who
had previously self-excluded.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c)
Cryoprecipitated AHF; d) Recovered Plasma.
Recall #B-881/884-7.
CODE Unit #38E20474.
MANUFACTURER American Red Cross Blood Services, Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by letter dated August 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana, Ohio, Illinois, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
taking the drug Proscar.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-895/896-7.
CODE Unit 38FN37281.
MANUFACTURER American Red Cross Blood Services, Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by letter dated January 5, 1996
and by telephone on January 26, 1996. Firm-initiated recall complete.
DISTRIBUTION Indiana and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose
spouse had hepatitis C.

_______________
PRODUCT Platelets. Recall #B-897-7.
CODE Unit numbers 38E09656 and 38E09653.
MANUFACTURER American Red Cross Blood Services, Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by telephone on December 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 2 units were distributed.

-10-REASON Blood products were prepared from units of whole
blood with extended collection times.

_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-898/899-7.
CODE Unit #03FX06420.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated April 2, 1997, and
by telephone on March 27, 1997. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products corresponded to a unit of Red
Blood Cells that was reported as clotted.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-900-7.
CODE Unit #03FV43408.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on March 12, 1997,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red
Blood cells that was reported as clotted.

_______________
PRODUCT Red Blood Cells. Recall #B-901-7.
CODE Unit #21Q62771.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated April 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-903/904-7.
CODE Unit #42K86167.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated March 25, 1997.
Firm-initiated recall complete.
-11-DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-905-7.
CODE Unit #42K83914.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by telephone on March 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking
the drug Methotrexate.

_______________
PRODUCT Red Blood Cells. Recall #B-906-7.
CODE Unit #42Y83723.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated March 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-907/908-7.
CODE Unit #42S47612.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated April 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT Platelets. Recall #B-913-7.
CODE Unit numbers: 4156355, 4156359, 4156362,
4156358, 4156360, 4156370.
MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, Alaska.

-12-RECALLED BY Manufacturer, by telephone on February 22, 1997.
Firm-initiated recall complete.
DISTRIBUTION Alaska.
QUANTITY 6 units were distributed.
REASON Blood products were labeled with extended
expiration dates.

_______________
PRODUCT Source Plasma. Recall #B-914-7.
CODE Unit numbers XM28528, XM27960, XM27151, XM26485,
XM25753, XM25270, XM24467, XM24120, XM23398,
XM22762, XM19617, XM18168, XM16331, XM15941,
XM15124, XM14349, XM13527, XM13079, XM12431,
XM10193, XM08356, XM06504, XM05642, XM04121,
XM02720, XM02400, XM01669, XM00517, XM00218.
MANUFACTURER Community Bio-Resources, Inc., Grand Rapids,
Michigan.
RECALLED BY Manufacturer, by letter dated July 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 29 units were distributed.
REASON Blood products were collected from a donor who
had sexual contact with an HIV positive
individual.

_______________
PRODUCT Platelets. Recall #B-915-7.
CODE Unit 11315-2655.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, inc., Scottsdale, Arizona, by
letter dated March 17, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole
blood designated as a difficult collection.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Recovered Plasma. Recall #B-862-7.
CODE Unit #24KH09152.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter April 2, 1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of cancer.

-13-_______________
PRODUCT Recovered Plasma. Recall #B-885-7.
CODE Unit #25-16362.
MANUFACTURER Michigan Community Blood Center, Grand Rapids,
Michigan.
RECALLED BY Manufacturer, by fax on December 5, 1996. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was not tested for viral markers.

_______________
PRODUCT Platelets. Recall #B-889-7.
CODE Unit numbers: 41-38622, 41-38624, 41-38625, 41-38626, 41-38627, 41-38629, 41-38631, 41-38635,
41-38636, 41-38639, 41-38642, 41-38644.
MANUFACTURER Michigan Community Blood Center, Traverse City,
Michigan.
RECALLED BY Manufacturer, by telephone on January 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 12 units were distributed.
REASON Blood products were shipped at an unacceptable
temperature.

_______________
PRODUCT Platelets. Recall #B-894-7.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 594-1191
for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.
RECALLED BY Manufacturer, by letter dated December 12, 1995.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 570 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.

_______________
PRODUCT Red Blood Cells. Recall #B-902-7.
CODE Unit #21GK70903.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on April 7,1997,
followed by letter dated April 9, 1997. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.

-14-REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-909/911-7.
CODE Unit numbers: a & c) 042H98676, 042FF34748,
042FW32359, 042J11375, 042FF04835, 042Y53911; b)
042FW32359.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters dated February 3, 1997,
and January 31, 1997. Firm-initiated recall
complete.
Distribution Ohio, California, Switzerland.
QUANTITY a) 6 units; b) 1 unit; c) 6 units were
distributed.
REASON Blood products were collected from a donor who
was taking the drug Megace.

_______________
PRODUCT Baxter's Hemofil M (Antihemophilic Factor
(Human) Method M Monoclonal Purified).
Recall #B-912-7.
CODE Lot numbers: 2935E075AA, 2935E076AA,
2935E097AA, 2935M004AA, 2935M005AA, 2935M016AA,
2935M017AA,
Foreign distribution: 2935E096AA.
ARC LOTS 29356071AA, 29356072AA.
MANUFACTURER Baxter Healthcare Corporation, Glendale,
California.
RECALLED BY Manufacturer, by letter on May 24 and 27, 1997,
and by fax on May 25, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 31,303 vials were distributed.
REASON Baxter's Antihemophilic Factor recorded
temperature deviations (lower validated
temperatures) during solvent detergent viral
inactivation treatment.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II ==========
_______________
PRODUCT Dial brand BC-101 Liquid Barcarbonate
Concentrate for Dialysis, in 1 gallon
containers. Recall #Z-644-7.
CODE Lot #612237C.
MANUFACTURER Gambro Healthcare, DeLand, Florida.
RECALLED BY Manufacturer, by telephone on June 13-14, 1996.
Firm-initiated recall complete.
-15-DISTRIBUTION New York, New Jersey, District of Columbia,
Illinois.
QUANTITY 580 cases (4 units per case) were distributed.
REASON The concentrate is diluted resulting in low
conductivity alarms at user clinics.

_______________
PRODUCT 2-K Dial Medical brand Acid Concentrate for
Bicarbonate Dialysate, ratio 1:44, in 55 gallon
drums. Product #AC-2041. Recall #Z-647-7.
CODE Lot #620807D.
MANUFACTURER Gambro Healthcare, Deland, Florida.
RECALLED BY Manufacturer, by telephone on July 29-30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Louisiana, South Carolina.
QUANTITY 7 drums were distributed.
REASON The concentrate magnesium content is below
specifications.

_______________
PRODUCT 3-K Dial brand Acid Concentrate for Bicarbonate
Dialysis ratio 1:44, Product #AC-2419, in 1
gallon containers and 55 gallon drums.
Recall #Z-648-7.
CODE Lot #70920D.
MANUFACTURER Gambro Healthcare, Deland, Florida.
RECALLED BY Manufacturer, by telephone on April 8-9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio, Virginia, Florida, New York, Pennsylvania,
Missouri.
QUANTITY 113 cases (4 1-gallon units per case) and 70 55-gallon drums were distributed.
REASON The concentrate is high for the magnesium
content specification.

_______________
PRODUCT Narrow Platform Abutment Screws, for use with
3.3 mm narrow platform endosseous implant
fixtures:
a) Product #SDCA568: healing Abutment, 3mm high
b) Product #SDCA569: healing Abutment, 4mm high
c) Product #SDCA570: healing Abutment, 5mm high
d) Product #SDCA594: Standard Abutment, 3mm high
e) Product #SDCA595: Standard Abutment, 4mm high
f) Product #SDCA596: Standard Abutment, 5mm
high. Recall #Z-649/654-7.
Lot numbers: a) 523929, 524276, 524774
b) 523958, 524277, 524937
c) 523972, 524278, 524956
d) 524051, 525404, 526296, 526297
-16- e) 524078, 525403, 526346
f) 524001, 525239, 526347.
MANUFACTURER Nobel Biocare AB, Gothenburg, Sweden.
RECALLED BY Nobel Biocare USA, Inc., Westmont, Illinois, by
letter dated April 17, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 753 units were distributed; firm estimated that
50% of product remained on market at time of
recall initiation.
REASON Some are slightly oversize in the threaded area
of the screw, and some resistance may be
encountered when attempting to tighten the
screw.

_______________
PRODUCT Rubber Dam Clamp and Rubber Dam Clamp Kits:
a) Ivory Brand Rubber Dam Clamp:
Product Code
b) Ivory Brand Rubber Dam Complete Kit,
c) Ivory Brand Rubber Dam Starter Kit, Type.
Recall #Z-655/657-7.
CODE Product Code Type Lot Numbers
57322 3 C6, Y6
57324 4 C6, A6, P6
57328 7 C6,A6, M6
57528 W7 A6
57330 7A C6
57336 8A A6, M6, Y6
57536 W8A C6, L6, M6, R6
57522 W3 L6, M6
57348 12A C6, A6
57352 13A C6, A6, M6
57356 14A C6, L6, A6, M6
57556 W14A C6, A6, Y6
57843 2T A6.
b) Product Code 57966,
Lot Nos. 082996, 111196, and 111196A;
c) Product Code 57968,
Lot Nos. 0929396, 100996 and 120396.
MANUFACTURER Heraeus Kulzer, Inc., South Bend, Indiana.
RECALLED BY Manufacturer, by letter March 19, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 57,890 units were distributed.
REASON Some clamps have broken during initial use or
after a few uses.

-17-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT Dial brand DiaLyte Concentrate for Bicarbonate
Dialysate, Product #BC-103, ratio 1:27.57, in 1
gallon jugs. Recall #Z-645-7.
CODE Lot #602123C.
MANUFACTURER Gambro Healthcare, Deland, Florida.
RECALLED BY Manufacturer, by telephone on July 10 and 11,
1996. Firm-initiated recall complete.
DISTRIBUTION Georgia, Pennsylvania, Wisconsin.
QUANTITY 184 cases (4 jugs per case) were distributed.
REASON The concentrate contains excessive mold.

_______________
PRODUCT 3-K Dial brand Acid Concentrate for Bicarbonate
Dialysis, ratio 1:35.83, Product #AC-1034, in 55
gallon plalstic drums. Recall #Z-646-7.
CODE All lots.
MANUFACTURER Gambro Healthcare, Deland, Florida.
RECALLED BY Manufacturer, by letter on March 7, 1997. Firm-initiated field correction complete.
DISTRIBUTION Texas, Pennsylvania, Tennessee, New Mexico,
North Carolina, Florida, Iowa, Kansas, Maryland,
Alabama.
QUANTITY 496 units were distributed.
REASON The sodium chloride concentration is stated
incorrectly on the label.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ====
_______________
PRODUCT Broiler Premix 3017-1, in 50 pound bags a
medicated feed containing roxarsone,
Lincomycin and Monensin. Recall #V-039-7.
CODE Lot #213126 EXP 5/99; Drug Lot #AB560 468.
MANUFACTURER Precision Microblenders, Inc., Ciales,Puerto
Rico.
RECALLED BY Manufacturer, by telephone on March 31, 1997.
Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 40 50-pound bags (2,000 pounds) were
distributed.
REASON Subpotent -- Roxarsone level was below
expected levels.

-18-

END OF ENFORCEMENT REPORT FOR JUNE 18, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for