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.
May 20, 1998 98-20
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Basha Foods brand Taboule Salad packaged in 7
ounce and 12 ounce containers and in 5 pound
bulk containers. Recall #F-491-8.
CODE All lots containing a three or four digit
numeric code which begins with the number 2 or
the number 02 and all lot numbers containing a
three or four digit code which begins with 3
or 03 and is followed by two numbers ranging
from 01 through 11.
MANUFACTURER Basha International Foods, Inc., Hamtramck,
Michigan.
RECALLED BY Manufacturer, by visit beginning February 20,
1998. Firm-initiated recall complete. See
also FDA press release P98-7, February 20,
1998.
DISTRIBUTION Illinois, Indiana, Michigan.
QUANTITY Approximately 1,250 pounds of taboule were
distributed.
REASON Products may be contaminated with Listeria
monocytogenes, Salmonella Arizona,
Enterobacter cloacae, or Citrobacter freundii.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Various bakery products:
1. 9 Inch Lemon Glazed Angelfood Cake, item
code 80362, net weight 24 ounce
2. Dillons Signature 6 German Chocolate
Brownies, item code 80375, net weight 8 ounce
3. Dillons Signature 6 Caramel Brownies, item
Code 80376, net weight 8 ounce
4. 7 Inch German Chocolate Cake, item code
80312, net weight 26 ounce
5. Supreme Chocolate Cake, item code, 80346,
net weight 20 ounce
6. 6 German Chocolate Cupcakes, item code
80371, net weight 10 ounce
7. 7 Inch Cherry White Cake, item code 80302,
net weight 25 ounce
8. 7 Inch Cherry Nut Cake, item code 80311,
net weight 26 ounce
9. Supreme Cherry White Cake, item code
80342, net weight 16 ounce
10. 6 Cherry White Cupcakes, item code 80368,
net weight 10 ounce
11. 7 Inch Devilsfood Cake, item code 80305,
net weight 26 ounce
12. 7 Inch Pecan Fudge Cake, item code 80306,
net weight 26 ounce
13. 7 Inch Chocolate Almond Cake, item code
80309, net weight 26 ounce
14. 8 Inch Devilsfood Cake, item code 80321,
net weight 33 ounce
15. Supreme Devilsfood Cake, item code 80344,
net weight 16 ounce
16. Supreme Pecan Fudge Cake, item code 80345,
net weight 20 ounce
17. 9 Inch Cherry Glazed Angelfood Cake, item
code 80363, net weight 24 ounce
18. 6 Devilsfood Cupcakes, item code, 80369,
net weight 10 ounce
19. 12 Pk. Mini Chocolate Cupcakes, item code
80412, net weight 8 ounce.
Recall #F-454/472-8.
CODE All misbranded product.
MANUFACTURER Dillons, Hutchinson, Kansas.
RECALLED BY Manufacturer, by fax on March 6, 11 and 12,
1998. Firm-initiated recall complete.
DISTRIBUTION Kansas.
QUANTITY Approximately 865 packages were distributed.
REASON The products contain undeclared certified
colors, FD&C Yellow No. 5, Yellow No. 6, Blue
No. 1, and Red No. 40.
_______________
PRODUCT Refrigerated pizza in 10 ounce pop-open cans,
12 cans per case, under various private labels
a. Kroger Pizza Crust Ready To Bake,
Distributed by The Kroger Co., Cincinnati, OH
b. America's Choice Pizza Crust, Distributed
by Compass Foods, Montvale, NJ
c. Stop & Shop Roll Out, Top, and Bake Pizza
Crust, Distributed by The Top & Shop
Supermarket Company, Boston, MA
d. Price Chopper Roll Out, Top and Bake
Hot'n Fresh Pizza Dough, Distributed by The
Price Chopper, Inc., Schenectady, NY
e. Merico Roll Out, Top & Bake Pizza Crust,
Distributed by Merico, Inc., St. Louis, MO
f. Weis Quality Hot'n Fresh Roll out...Top
and Bake Pizza Crust, Packed for Weis Markets
Inc., Sunbury, PA
g. Roundys Quality Ready To Bake Pizza Crust,
Distributed by Roundy's Inc., Milwaukee, WI
h. Acme Hot 'N Fresh Pizza Crust, Distributed
by American Procurement & Logistics Co., Salt
Lake City, UT
I. Grand Union Read to Top & Bake Pizza
Crust, Distributed by The Grand Union Co.,
Wayne, NJ
j. Flavorite Hot'n Fresh Roll Out, Top & Bake
Pizza Crust, Distributed by Preferred
Products, Inc., Chaska, MN
k. HyVee Pizza Crust, Distributed by Hy-Vee
Inc., West Des Moines, IA
l. Food Club Roll Out..Top & Bake Hot'n Fresh
Pizza Crust, Distributed by Topco Associates,
Inc., Skokie, IL
m. Smith's Hot'n Fresh Roll Out, Top and Bake
Pizza Crust, Distributed by Smith's Food &
Drug, Layton, UT. Recall #F-490-8.
CODE All product with an expiration code of May 31,
AFDxx or earlier.
MANUFACTURER Merico, Inc., Carrollton, Texas.
RECALLED BY The Earth Grains Company, Clayton, Missouri
(responsible for labeling), by letter dated
April 3, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 5,200 - 7,000 cases were
distributed.
REASON Product contains undeclared milk.
_______________
PRODUCT Holiday Cookies (St. Patrick's Day variety),
manufactured by several different companies
who packaged the cookies in bulk into fully
labeled cases. Recall #F-492-8.
CODE All with codes on the market as of February
26, 1998.
MANUFACTURER Various manufacturers.
RECALLED BY Dillons, Hutchinson, Kansas
(repacker/responsible firm), by fax on
February 26, 1998. Firm-initiated recall
complete.
DISTRIBUTION Kansas.
QUANTITY 700 5-pound or 10-pound cases were
distributed.
REASON Product does not bear an ingredient statement
and contains eggs.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT Amenity Hair Conditioner and Hand & Body
Products: a) Canterbury conditioner, 1.25
fluid ounce bottle; b) Canterbury Hand & Body
Lotion, 1.25 fluid ounce bottle.
Recall #F-488/489-8.
CODE a) I257P, J207P; b) I187P, KII7P, K157P,
L087P.
MANUFACTURER Packaging Technology GP, Inc., Waukegan,
Illinois.
RECALLED BY The Dial Corporation, Scottsdale, Arizona, by
letter on April 1, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 614 cases (288 units per case) were
distributed.
REASON Products are contaminated with Burkholderia
cepacia (formally Pseudomonas).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
============
_______________
PRODUCT Premarin Tablets, (Conjugated Estrogens
tablets, USP), Rx, 1.25 mg, repacked into 100
count bottles. NDC #0046-0866-81.
Recall #D-136-8.
CODE Lot #9971786 EXP 5/02.
MANUFACTURER Wyeth-Ayerst Laboratories, Philadelphia,
Pennsylvania.
RECALLED BY National PharmPak Services, Inc., Zanesville,
Ohio (repacker/responsible firm), by letter
faxed on April 20, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,750 bottles were distributed.
REASON Mispackaging - Some units may contain Ceftin
(Cephalosporin) 250 mg tablets (light blue
colored).
_______________
PRODUCT Levothroid (levothyroxine sodium tablets,
USP), 100 mcg tablets, repackaged in 100 count
bottles, indicated as replacement therapy for
diminished thyroid function resulting in
hypothyroidism, distributed under the AHP
American Health Packaging label.
NDC #0456-0323-01. Recall #D-137-8.
CODE Lot #6667 EXP 11/99.
MANUFACTURER Forest Pharmaceuticals, Inc., St. Louis,
Missouri.
RECALLED BY AmeriSource Health Services, doing business as
American Health Packaging, Columbus, Ohio, by
letter on April 21, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Virginia, Ohio, Kentucky, New Jersey,
Tennessee, Massachusetts, Texas, New York,
Florida.
QUANTITY 324 bottles were distributed.
REASON Dissolution failure.
_______________
PRODUCT Levothroid Tablets (Levothyroxine sodium
tablets, USP), 100 mcg, in 5,000 tablet
bottles, Rx, indicated as replacement therapy
for diminished thyroid function resulting in
hypothyroidism. NDC #0456-0323-51.
Recall #D-138-8.
CODE Lot #109732 EXP 11/99.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati,
Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., subsidiary of
Forest Laboratories, Inc., St. Louis,
Missouri, by letter on April 17, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION California, Illinois, New York, Ohio, Oregon.
QUANTITY 282 5,000-tablet bottles were distributed.
REASON Dissolution failure.
_______________
PRODUCT Levothroid (Levothyroxine Sodium Tablets USP),
100 mcg, repackaged in 100 count bottles,
under the National PharmPak label, indicated
as replacement therapy for diminished thyroid
function resulting in hypothyroidism,
NDC #0456-0323-01. Recall #D-139-8.
CODE Lot #109732 EXP 11/99.
MANUFACTURER Forest Pharmaceuticals, Inc., St. Louis,
Missouri (responsible firm).
RECALLED BY National PharmPak Services, Inc., Zanesville,
Ohio (repacker), by fax on April 27, 1998,
followed by telephone on April 28, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,485 bottles were distributed.
REASON Dissolution failure.
_______________
PRODUCT Levothroid Tablets (Levothyroxine sodium,
USP), 50 mcg, hospital unit dose blister
strips, 10 tablets per strip, 10 strips per
carton, Rx, for use as replacement or
substitution therapy for diminished or absent
thyroid function. Recall #D-142-8.
CODE Lot #69635 EXP 7/98.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati,
Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., subsidiary of
Forest Laboratories, Inc., St. Louis,
Missouri, by letters dated April 22 and 29,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,826 boxes were distributed.
REASON Subpotent (stability 18 month interval).
_______________
PRODUCT Armour Thyroid Tablets (Thyroid tablets, USP),
1 grain (60 mg), in 50,000 tablet drums, Rx
for use as a replacement or supplemental
therapy in patients with hypothyroidism.
NDC #0456-0459-69. Recall #D-143-8.
CODE Lot #19813 EXP 10/98.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati,
Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., subsidiary of
Forest Laboratories, Inc., St. Louis,
Missouri, by letter on April 16, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Rhode Island, Arkansas, Wisconsin.
QUANTITY 8-50,000 drums were distributed.
REASON Tablets were found out of specification for
weight and thickness.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Q-Tuss Sustained Release (SR) Tablets
(Phenylephrine HCL 25mg/phenylpropanolamine
HCL 50 mg/Chlorpheniramine Maleate 8
mg/Hyoscyamine Sulfate 0.19 mg/Atropine
Sulfate 0.04 mg/Scopolamine Hydrobromine 0.01
mg), in bottles of 100 and 500,
antihistaminic, nasal decongestant and
anti-secretory preparation. Recall #D-131-8.
CODE 043096B 002047B 043096C
015067A 043096D 015067B
043096E 016067A 044096A
016067B 044096B 030106A
001047D 031106A 001047E
031106B 001047F 031106C
002047A 031106D.
MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated January 22,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Alabama.
QUANTITY 78,255 bottles were distributed.
REASON Incomplete validation data.
_______________
PRODUCT Atrohist Plus Sustained Release (SR) Tablets,
(Phenylephrine HCL 25 mg/phenylpropanolamine
HCL 50 mg/Chlorpheniramine Maleate 8
mg/Hyoscyamine Sulfate 0.19 mg/Atropine
Sulfate 0.04 mg/Scopolamine Hydrobromide 0.01
mg), in bottles of 100 and 500 tablets, and 4
tablet samples, Rx, antihistaminic, nasal
decongestant and anti-secretory preparation.
Recall #D-132-8.
CODE Lot numbers:
045056A 046056C 047056A
001086A 002086A 003086A
004086A 022106A 023106C
003017A 004017A 064047B
005087C 006087A.
MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated January 22,
1998. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 537,692 bottles were distributed.
REASON Incomplete validation data.
_______________
PRODUCT Cyanocobalamin Injection, USP, 1,000 mcg/mL,
in 1 mL multiple dose vials, 25 vials per
carton, Rx indicated for Vitamin B12
deficiencies. NDC #0469-1044-25.
Recall #D-133-8.
CODE Lot numbers: 370007, 370080, 370139, 370187,
370305, 370338, 370396, 370489, 370570,
382027.
MANUFACTURER FUJISAWA USA, Inc., Grand Island, New York.
RECALLED BY Manufacturer, by letter dated April 10, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Egypt, Saudi Arabia, Canada.
QUANTITY 1,651,450 units (66,058 cartons) were
distributed.
REASON Unapproved change in raw material.
_______________
PRODUCT Luvox (Fluvoxamine Maleate) 100 mg, in unit
dose blisters (hospital use) of 10 tablets
with 10 tablets per blister card, Rx,
indicated for the treatment of obsessions and
compulsions in patients with Obsessive
Compulsive Disorder(OCD), as defined in the
DMS-III-R. Recall #D-135-8.
CODE Lot #88007.
MANUFACTURER Solvay Pharmaceuticals, Inc., Marietta,
Georgia.
RECALLED BY Manufacturer, by letter sent on April 7, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,944 units were distributed.
REASON Some units are missing the strength
declaration.
_______________
PRODUCT Promotion brochures for (OTC):
a) DHEA Therapy Tablets, Wild Yam, Ginkgo
Biloba, Gotu Kola, Siberian Ginseng, Kelp,
L-Tyrosine, L-Glutamine, L-Arginine,
L-Ornithine) 90 tablets per bottle;
b) Pycnogenol Capsules, (Grape seed extract,
Pine bark extract...) in 60 capsule bottles.
Recall #D-140/141-8.
CODE None.
MANUFACTURER Energy Factors, Inc., Largo, Florida.
RECALLED BY Jack Davis and Associates, Inc., Albany,
Georgia (own label distributor/responsible
firm), by instructing sales people to pickup
product on February 26, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Misbranding - Promotional literature makes
unapproved drug claims.
_______________
UPDATE Gliadel Wafer, Polifeprosan 20 with Carmustine
Implant, (Rhone Poulenc Rorer Pharmaceuticals,
Inc., Collegeville, Pennsylvania),
Recall #D-065-8, which appeared in the
February 18, 1998 has been extended to include
lot #K97B4.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-798-8.
CODE Unit #49Y46174.
MANUFACTURER American Red Cross Southwest Region, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on December 17,
1997. Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Failure to quarantine a blood product that was
exposed to uncontrolled shipping and handling
conditions.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-925/926-8.
CODE Unit #22FR83033.
MANUFACTURER American Red Cross Blood Services,
Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by letters dated September 3 and
15, 1997, and October 3, 1997, and by
telephone on August 29, 1997. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were not quarantined after
receiving information concerning a post
donation illness.
_______________
PRODUCT Platelets. Recall #B-993-8.
CODE Unit #12R53725.
MANUFACTURER American Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letter dated December 8,
1997. Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was incorrectly labeled with the
wrong ABO typing.
_______________
PRODUCT Pheresis, Split Unit, Leukocytes Removed.
Recall #B-1010-8.
CODE Unit #42FR60438.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated November 13,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Leuko-reduced blood products were not
collected in accordance with manufacturers
instructions.
_______________
PRODUCT Red Blood Cells. Recall #B-1011-8.
CODE Unit #3872501.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by letter dated either September
12 or 15, 1997. Firm-initiated recall
complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had ear piercing within 12 months of donation.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1012/1013-8.
CODE Unit #3871699.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated either September 12
or 16, 1997. Firm-initiated recall complete.
DISTRIBUTION Georgia, New Jersey, New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
whose suitability was not adequately
determined.
_______________
PRODUCT Red Blood Cells. Recall #B-1014-8.
CODE Unit #3876786.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated August 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had taken medication within four weeks of
donation.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1021/1022-8.
CODE Unit #3871684.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated September 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an
unsuitable donor.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1027/1028-8.
CODE Unit #2258987.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated either September 12
or 15, 1997. Firm-initiated recall complete.
DISTRIBUTION Florida, Kentucky, Missouri.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
whose suitability was not adequately
determined.
_______________
PRODUCT Red Blood Cells. Recall #B-1029-8.
CODE Unit #2258972.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated either September 12
or 15, 1997. Firm-initiated recall complete.
DISTRIBUTION Kentucky and Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
suitability was not adequately determined.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1031/1032-8.
CODE Unit #3874773.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated July 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION New Jersey, District of Columbia,
Massachusetts.
QUANTITY 1 unit of each component.
REASON Blood product was collected from a donor whose
suitability was not adequately determined.
_______________
PRODUCT Red Blood Cells. Recall #B-1040-8.
CODE Unit #2258991.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated September 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
suitability was not adequately determined.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1041/1042-8.
CODE Unit #2258926.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated September 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kentucky and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood product was collected from a donor whose
suitability was not adequately determined.
_______________
PRODUCT Red Blood Cells, Leukocytes Reduced.
Recall #B-1043-8.
CODE Unit numbers: 49GF05481, 49GF05482,
49GF05483, 49GF05504, 49GF05510, 49L85971,
49R82971, 49R82976, 49R82985, 49S74686,
49S74688, 49Y45703, 49Y45705.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on December 15,
1997 and by letters dated December 17, 1997,
and January 20, 1998. Firm-initiated recall
complete.
DISTRIBUTION Oklahoma and Texas.
QUANTITY 13 units were distributed.
REASON Blood products were mislabeled as CMV antibody
negative.
_______________
PRODUCT Red Blood Cells. Recall #B-1045-8.
CODE Unit #06LR57563.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by telephone on July 31, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined while
resolving an ABO/RH historical discrepancy,
which confirmed the donor as B positive, was
labeled as B negative.
_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-1046/1047-8.
CODE Unit #13FJ28936.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.
RECALLED BY Manufacturer, by letter dated January 29 and
30, 1998. Firm-initiated recall complete.
DISTRIBUTION Michigan.
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 Red Blood Cells. Recall #B-1048-8.
CODE Unit #38FC32811.
MANUFACTURER American Red Cross Blood Services, Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by telephone on January 21,
1998. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
previously tested CMV positive, was labeled
CMV negative.
_______________
PRODUCT Red Blood Cells. Recall #B-1049-8.
CODE Unit #18FC94471.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by telephone on January 12,
1998. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from an overweight
unit of whole blood.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1065-8.
CODE Unit #1041735.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by letter dated January 9, 1998.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area designated as endemic for
malaria.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1066/1067-8.
CODE Unit numbers: a) 1037096, 1030621, 1023482
b) 1023482.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by letter dated January 9, 1998.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY a) 3 units; b) 1 unit was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as
endemic for malaria.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1068/1069-8.
CODE Unit #36-13640.
MANUFACTURER Michigan Community Blood Centers, Bay City,
Michigan.
RECALLED BY Manufacturer, by letter on December 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with Graves disease.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1070/1071-8.
CODE Unit numbers: 61-30567 and 61-24420.
MANUFACTURER Michigan Community Blood Centers, Grand
Rapids, Michigan.
RECALLED BY Manufacturer, by letter on July 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan and California.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor
with Graves disease.
_______________
PRODUCT Red Blood Cells. Recall #B-1092-8.
CODE Unit numbers: 0310652 and 0310612.
MANUFACTURER Inland Northwest Blood Center, Spokane,
Washington.
RECALLED BY Manufacturer, by telephone on January 8, 1998.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 2 units were distributed.
REASON Blood products were incorrectly labeled as
irradiated.
_______________
PRODUCT Red Blood Cells. Recall #B-1093-8.
CODE Unit #2257923.
MANUFACTURER Inland Northwest Blood Center, Spokane,
Washington.
RECALLED BY Manufacturer, by letter dated December 23,
1997. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that
compromises the sterility of the unit.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-815-8.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance
(301) 827-6220 for individual unit numbers
recalled.
MANUFACTURER United Blood Services, Albuquerque, New
Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone or fax between January 15 and 21,
1998, followed by letter dated February 13,
1998. Firm-initiated recall complete.
DISTRIBUTION New Mexico and Utah.
QUANTITY 96 units were distributed.
REASON Blood products were leukoreduced by filtration
at an unacceptable temperature.
_______________
PRODUCT Platelets. Recall #B-987-8.
CODE Unit #50LH00012.
MANUFACTURER American Red Cross Blood Services, Toledo,
Ohio.
RECALLED BY Manufacturer, by letter dated December 9,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood which may have had an extended
collection time.
_______________
PRODUCT Red Blood Cells, Leukocytes Removed By
Filtration. Recall #B-1064-8.
CODE Unit numbers: 1041172, 1041173.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on November 24,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio and Indiana.
QUANTITY 2 units were distributed.
REASON Unlicensed blood products were distributed
without obliteration of the firm's license
number.
_______________
PRODUCT Recovered Plasma. Recall #B-1072-8.
CODE 61-30567, 61-24420.
MANUFACTURER Michigan Community Blood Centers, Grand
Rapids, Michigan.
RECALLED BY Manufacturer, by letter on July 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan and California.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
with Graves disease.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT IVAC MedSystem III Administration Sets, Model
28080E. Recall #Z-549-8.
CODE Lot #801548.
MANUFACTURER Sistemas Medico Alaris, SA DE C.V., Tijuana,
Mexico.
RECALLED BY Alaris Medical Systems, Inc., San Diego,
California, by telephone and by letter on
April 7, 1998. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Illinois, Indiana, North
Carolina, Wisconsin.
QUANTITY 500 sets were distributed; firm estimated that
384 sets remained on market at time of recall
initiation.
REASON Devices were mis-assembled. The tubing
sections were reversed which could result in
medication not being delivered and/or blood
being drawn from the patients IV site.
_______________
PRODUCT Dermagraft brand of Human Dermal Replacement,
indicated for use as a temporary wound
covering for surgically excised thermal burn
wounds: a) Dermagraft-TC; b) Dermagraft.
Recall #Z-571/572-8.
CODE Lot numbers: a) 101182 to 102722, non-sequential;
b) 101720 to 12783, non-sequential.
MANUFACTURER Advanced Tissue Sciences, Inc. (ATS), La
Jolla, California.
RECALLED BY Manufacturer, by letter on March 25, 1998, and
by press release on March 30, 1998.
Firm-initiated recall ongoing.
DISTRIBUTIO a) Nationwide and international; b)
international.
QUANTITY a) 478 units; b) 281 units were distributed.
REASON Devices were manufactured and distributed from
fetal bovine serum that did not meet firms
specification for endotoxin.
_______________
UPDATE Recall #Z-514-8, Model TED 60T Portable Oxygen
Monitor (Teledyne Electronic Technologies
Analytical Instruments (TET/AI), City of
Industry, California), which appeared in the
April 22, 1998 Enforcement Report should read:
RECALLED BY: Manufacturer, by letter on
August 27, 1996. Firm-initiated recall
ongoing.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Ormco C-Type Release Module, for orthodontic
headgear or neck pads:
a) Part No. 715-2020, medium (white) force;
b) Part No. 715-2021, heavy (gray) force.
Recall #Z-563/564-8.
CODE Lot numbers beginning with 7K, 7L, 7M, 8A, 8B,
and 8C, covering lots manufactured in October,
November and December 1997, and January,
February, and March 1998.
MANUFACTURER Sybron Dental Specialties, Inc., Orange,
California (responsible firm).
RECALLED BY Ormco Corporation, subsidiary of Sybron Dental
Specialties, Inc., Glendora, California, by
letter on March 19, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,152 units were distributed.
REASON The release module does not release the neck
pad or headgear from the face bow if it is
accidentally pulled away from the patient.
_______________
PRODUCT Motloid Cold Pac Tooth Acrylic, Formula 302M,
in 8 fluid ounce and 16 fluid ounce bottles, a
liquid self cure temporary crown and bridge
resin monomer (cross-linked, colorfast) used
to prepare temporary dental work.
Recall #Z-567-8.
CODE Lot Nos. 348601 and 348602.
MANUFACTURER The Motloid Company, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on January 29,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and The Netherlands.
QUANTITY 96 8-fluid ounce bottles and 60 16-fluid ounce
bottles were distributed.
REASON The resin does not harden.
_______________
PRODUCT Motloid Cold Pac Tooth Acrylic, Formula 302M,
in 4 fluid ounce and 8 fluid ounce bottles, a
liquid self cure temporary crown and bridge
resin monomer (cross-linked, colorfast), used
to prepare temporary dental work.
Recall #Z-568-8.
CODE Lot numbers: 363701 (4 oz), 363702 (8 oz).
MANUFACTURER The Motloid Company, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on February 4,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 200 4-fluid ounce and 144 8-fluid ounce
bottles were distributed; firm estimated that
50 percent of the product remained on market
at time of recall initiation.
REASON The resin does not harden.
END OF ENFORCEMENT REPORT FOR MAY 20, 1998. BLANK PAGES MAY
FOLLOW.
####
End of Enforcement Report for
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