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.
April 8, 1998 98-14
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Wang Derm brand Salted Scomber Fish, also
called Pla Too in Thai), vacuum packed in
flexible plastic bags, approximately 8 ounces
per bag. Recall #F-192-8.
CODE None.
MANUFACTURER Wang Derm Exporter L.P., Bangkok, Thailand.
RECALLED BY Vasinee Food Corporation, Brooklyn, New York
(importer), by letter dated November 25, 1997,
and by fax on December 17, 1997. Completed
recall resulted from sample analysis and
follow-up by the New York State Department of
Agriculture and Markets.
DISTRIBUTION New York, Massachusetts, Connecticut,
Maryland, New Jersey, Illinois, Rhode Island,
Pennsylvania, Tennessee.
QUANTITY 102 cases (36 bags per case) were distributed.
REASON The product, uneviscerated dried fish, has
the potential to support the growth of and
toxin production by Clostridium botulinum.
_______________
PRODUCT Rich's Carrot Cake, 8" Uniced, Round Layer
Cake. Recall #F-194-8.
CODE All lots currently within expiration date.
Products coded 7152 thru 8056 are subject to
recall.
MANUFACTURER Country Oven Bakery, Bowling Green, Kentucky.
RECALLED BY Rich Products Corporation, Buffalo, New York,
by memorandum and letter dated March 2, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and United Arab Emirates.
QUANTITY 4,550 cases (24 cakes per case) were
distributed.
REASON Product contains undeclared eggs.
_______________
PRODUCT a) Dominick's Bakery Fudge Iced Brownies,
whole, chocolate brownie with icing in a
square foil pan with a clear plastic lid,
approximately 18 ounces and 7" square
b) Brownie Slices, square iced chocolate
brownie slices in a hinged clear plastic dome
package, 2 slice package and 6 slice package.
Recall #F-290/291-8.
CODE All product with Sell By dates prior to Mar
22, 98.
MANUFACTURER Dominick's Commissary, Northlake, Illinois.
RECALLED BY Dominick's Finer Foods, Inc., Northlake,
Illinois, by telephone on March 14, 1998,
followed by E-mail. Firm-initiated recall
complete.
DISTRIBUTION Illinois and Indiana.
QUANTITY 2,521 packages of Fudge Iced Brownies, 14,287
packages of 2 Brownie Slices, and 263 packages
of 6 Brownie Slices were distributed and sold.
Firm estimates none of the products remain on
the market.
REASON Products contain undeclared whole eggs.
_______________
PRODUCT Fire Roasted Vegetable with Roasted Garlic and
Sundried Tomato Gourmet Style Gardenburger
Veggie Patties. Recall #F-339-8.
CODE The individual boxes contain the following
codes: 012099, 020999, 021099, 022599,
022699, 030699, 021199, 021299, 021399.
MANUFACTURER Gardenburger, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by telephone beginning on March
17, 1998, and by press release on March 18,
1998. Additional telephone calls, letters and
a press release were issued on April 2, 1998,
extending the recall to additional codes.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,287 cases (12 boxes per case) were
distributed.
REASON Product contains undeclared egg whites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT DiaB Extra Comprehensive Wound Nutrition
Tablet Dietary Supplement, in bottles of 60.
Recall #F-193-8.
CODE Lot Number 740410, no expiration date.
MANUFACTURER Alpine Health Industries, Orem, Utah.
RECALLED BY Carrington Laboratories, Inc., Irving, Texas,
by letter dated July 15, 1998. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,429 bottles were distributed. Firm
estimates none remains on the market.
REASON Product contains excessive levels of lead.
_______________
PRODUCT Popcorn Tins that contain cheese, caramel, and
regular popcorn with Christmas, NFL or
miscellaneous decorations in 3 1/2 gallon (38
oz.) or 5 1/2 gallon (60 ounce tins).
Recall #F-289-8.
CODE All product which fails to declared FD&C
Yellow No. 5 & 6.
MANUFACTURER Golden Harvest Products, Inc., Ontario,
California, and Houston Harvest Gift Products,
LLC, Overland Park, Kansas.
RECALLED BY Houston Harvest Gift Products, LLC, Overland
Park, Kansas, by fax letter dated December 12,
1997, followed by certified letter dated
February 26, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,174,767 38-ounce tins and 400,872 60-ounce
tins were distributed.
REASON Product contains undeclared FD&C Yellow No. 5
& 6.
_______________
PRODUCT Caffeine Free Coca Cola Classic in 12 ounce
cans packed in 24-packs. Recall #F-323-8.
CODE "SEP 21 98 HOE 1330" through "SEP 21 98 HOE
1342".
MANUFACTURER Coca-Cola Bottling Company Indianapolis, Inc.,
Speedway, Indiana.
RECALLED BY Manufacturer, by press releases on January 15
and 16, 1998, and by visits on January 9 and
16, 1998. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY Approximately 281 cases (24 cans per case)
were distributed.
REASON Product is contaminated with ammonia, which
may cause it to be injurious to health.
_______________
PRODUCT Basha Foods brand Hommus packaged in plastic
containers, a refrigerated dip-like product
made primarily of chick peas:
a) Hommus Original in 8 ounce, 16 ounce and 5
pound containers;
b) Hommus Vegetable, in 8 ounce containers
c) Hommus South-of-the-Border, in 8 ounce
containers
d) Hommus Roasted Red Pepper, in 8 ounce
containers
e) Hommus Scallion, in 8 ounce containers
f) Hommus Garlic, in 8 ounce containers
g) Hommus Dill, in 8 ounce containers
h) Hommus Zesty, in 8 ounce containers.
Recall #F-324/331-8.
CODE All lots.
MANUFACTURER Basha International Foods, Inc., Hamtramck,
Michigan.
RECALLED BY Manufacturer, by visit beginning on March 6,
1998. Firm-initiated recall complete.
DISTRIBUTION Colorado, Florida, Illinois, Michigan.
QUANTITY Approximately 32,000 pounds of product were
distributed.
REASON Products contain undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-514-8.
CODE Unit numbers: 4799682, 4799560, 4760515,
4760139, 4760146, 4799585, 4799594, 4761333,
4761551.
MANUFACTURER National Naval Medical Center, Bethesda,
Maryland.
RECALLED BY Manufacturer, by telephone on or about
February 5, 1997. Firm-initiated recall
complete.
DISTRIBUTION New Jersey.
QUANTITY 9 units were distributed.
REASON Blood products were not tested for HIV-1 Ag.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-618/619-8.
CODE Unit #1385890.
MANUFACTURER Central Texas Regional Blood and Tissue
Center, Austin, Texas.
RECALLED BY Manufacturer, by letter dated September 23,
1997, and October 17, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of exposure to hepatitis.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c)
Platelets, Pheresis. Recall #B-645/647-8.
CODE Unit numbers: a) 038E50493, 038K43442,
038K43521, 038K44340, 038FC18942, 038FC26037,
038FC26040, 038FC26399, 038FC26810
b) 038E50493, 038K43442, 038K43521, 038FC26037
c) 038P43542, 038P47121, 038P47190.
MANUFACTURER American Red Cross Great Lakes Region, Fort
Wayne, Indiana.
RECALLED BY Manufacturer, by telephone on August 19, 1997,
and by letter dated September 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana and Ohio.
QUANTITY 9 units; b) 4 units; c) 3 units were
distributed.
REASON Blood products were mislabeled as CMV antibody
negative, were distributed.
_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF;
c) Plasma; d) Platelets, for Further
Manufacture; e) Recovered Plasma.
Recall #B-657/661-8.
CODE Unit numbers: a) 53FQ28625 and 53FQ10004
b) 53FQ28625; c) 53FQ10004; d) 53FQ10004
e) 53FQ28625.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated October 21 and
24, 1997, and December 4, 1997. Firm-initiated recall complete.
DISTRIBUTION Maryland, District of Columbia, Pennsylvania,
Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit;
e) 1 unit was distributed.
REASON Blood product were collected from a donor who
reported previously testing positive for
hepatitis.
_______________
PRODUCT Source Leukocytes, For Manufacturing Use Only.
Recall #B-693-8.
CODE Unit #01KK33558.
MANUFACTURER American Red Cross Blood Services, Syracuse,
New York.
RECALLED BY Manufacturer, by fax on May 30, 1997. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
taking the drug Methotrexate.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c)
Source Leukocytes; d) Recovered Plasma; e)
Platelets for further manufacture.
Recall #B-830/834-8.
CODE Unit numbers: a) 2194948, 1609413
b) 1609413; c) 2194948; d) 2194948
e) 2194948.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter on September 8 and 17,
1997. Firm-initiated recall complete.
DISTRIBUTION Indiana, New Jersey, Switzerland.
QUANTITY a) 2 units; b-e) 1 unit of each component was
distributed.
REASON Blood products were collected from donors
taking the drug Proscar.
_______________
PRODUCT Recovered Plasma. Recall #B-
-8.
CODE Unit #13FJ26037.
MANUFACTURER American Red Cross Southeastern Regional,
Detroit, Michigan.
RECALLED BY Manufacturer, by fax dated January 14, 1998.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of cancer.
_______________
PRODUCT Red Blood Cells. Recall #B-854-8.
CODE Unit #13FM21536.
MANUFACTURER American Red Cross Southeastern Region,
Detroit, Michigan.
RECALLED BY Manufacturer, by letter dated October 10,
1997. Firm-initiated recall complete.
DISTRIBUTION Michigan.
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-856/857-8.
CODE Unit #38-34277.
MANUFACTURER Michigan Community Blood Centers, Midland,
Michigan.
RECALLED BY Manufacturer, by letter on March 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of Hashimoto's Disease.
_______________
PRODUCT a) Recovered Plasma; b) Platelets for Further
Manufacture. Recall #B-861/862-8.
CODE Unit #18R86354.
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by letter or fax on September 8,
1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor
whose spouse tested positive for hepatitis C.
_______________
PRODUCT Red Blood Cells. Recall #B-865-8.
CODE Unit #0103837.
MANUFACTURER Ashford Blood Bank, Inc., Ashford Medical
Center, Santruce, Puerto Rico.
RECALLED BY Manufacturer, by telephone on September 2,
1997. Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for
the antibody to the Hepatitis B core antigen
(HBc), with neither duplicate nor confirmatory
test performed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-515-8.
CODE Unit #4764980.
MANUFACTURER National Naval Medical Center, Bethesda,
Maryland.
RECALLED BY Manufacturer, by telephone on or about
February 5, 1997. Firm-initiated recall
complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood products were not tested for HIV-1 Ag.
_______________
PRODUCT Red Blood Cells. Recall #B-560-8.
CODE Unit #17182-2574.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Manufacturer, by telephone on September 17,
1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product may have remained at room
temperature for an unacceptable length of
time.
_______________
PRODUCT Red Blood Cells. Recall #B-855-8.
CODE Unit #38FC31432.
MANUFACTURER American Red Cross - Fort Wayne Region, Fort
Wayne, Indiana.
RECALLED BY Manufacturer, by telephone on December 19,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was exposed to unacceptable
temperatures.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT a) VAPR Side Effect Electrode, Sterile,
Disposable, Catalog No. 225301
b) VAPR Angled Side Effect Electrode, Sterile,
Disposable, Catalog No. 225302, used in
arthrosopic surgical procedures.
Recall #Z-474/475-8.
CODE Model #25301, Lot numbers: 970432, 970722,
9705801, 9706801, 9707802 9708803, 9709801,
9709802, 9709804, 9709805,9709806,9709807
Model #225302, Lot numbers: 970433, 9707806,
970724, 9709803.
MANUFACTURER Gyrus Medical Ltd., Cardiff, Wales, United
Kingdom.
RECALLED BY Mitek Products, Westwood, Massachusetts, by
letter on March 23, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Austria, France, Italy, Spain
Japan, United Kingdom, Scotland.
QUANTITY a) 5677 units; b) 729 units were distributed.
REASON Electrode may crack and fragment resulting in
medical intervention.
_______________
PRODUCT Suture Retrievers, packaged individually in
sterile Tyvek pouches, a component of the BTS
Mini-Laparotomy MMK Set, Model UM-250, and the
BTS Urethropexy Suture Placement Set, Model
UM-300, a sterile, disposable device (for
single patient use only) used to capture and
retrieve the suture tails during a
urethropexy, or an MMK surgical procedure,
included as a component of urethropexy sets,
and of mini-laparotomy MMK kits, and is not
sold separately. Recall #Z-480/481-8.
CODE Lot #9ML80206-04 (Model UM-250,
Mini-Laparoscopy MMK Set) and Lot #9ML71201-03
(Model UM-300, Urethropexy Kits).
MANUFACTURER Louisville Laboratories, Inc., Louisville,
Kentucky.
RECALLED BY MedWorks Corporation, Louisville, Kentucky, by
letter on March 6, 1998. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania, New Jersey, Virginia, Illinois,
Nevada, Oklahoma, Washington state.
QUANTITY 56 surgical sets were distributed.
REASON Lack of assurance of sterility of the devices
due to possible puncture of the packaging by
sharp tip of Suture Retriever.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Stone Extractor Baskets, used for endoscopic
removal of stones and foreign bodies.
Recall #Z-423/473-8.
CODE 1. Product No. BMB5-2X4-8;
2. Product No. MB5-2X4-8;
3. Product No. MB5-2X4-8-MP3205;
4. Product No. MB5-3X6-8;
5. Product No. MBG-220-1.5X2.5;
6. Product No. MBG-220-2X4;
7. Product No. MPB-2X4-8;
8. Product No. MPB-3X6-8;
9. Product No. MSB-1.5X3-5;
10. Product No. MSB-1.5X3.5-0169;
11. Product No. MSB-1.5X3.5-0346;
12. Product No. MSB-1.5X3.5-0463;
13. Product No. MSB-1.5X3.5-F;
14. Product No. MSB-1.5X3.5-F-0169;
15. Product No. MSB-1.5X3.5-F-0463;
16. Product No. MSB-1.5X3.5-SF;
17. Product No. MSB-2.5X5;
18. Product No. MSB-2.5X5-0169;
19. Product No. MSB-2.5X5-0346;
20. Product No. MSB-2.5X5-0463;
21. Product No. MSB-2.5X5-F;
22. Product No. MSB-2.5X5-F-0169;
23. Product No. MSB-2.5X5-F-0463;
24. Product No. MSB-2.5X5-SF;
25. Product No. MSB-2X4;
26. Product No. MSB-2X4-0169;
27. Product No. MSB-2X4-0346;
28. Product No. MSB-2X4-0463;
29. Product No. MSB-2X4-6;
30. Product No. MSB-2X4-F;
31. Product No. MSB-2X4-F-0169;
32. Product No. MSB-2X4-F-0463;
33. Product No. MSB-2X4-SF;
34. Product No. MSB-3X6;
35. Product No. MSB-3X6-0169;
36. Product No. MSB-3X6-0346;
37. Product No. MSB-3X6-0463;
38. Product No. MSB-3X6-6;
39. Product No. MSB-3X6-F;
40. Product No. MSB-3X6-F-0169;
41. Product No. MSB-3X6-F-0463;
42. Product No. MSB-3X6-SF;
43. Product No. MSB-60-2X4;
44. Product No. MSB5-1.5X3.5;
45. Product No. MSB5-2X4;
46. Product No. MWB-1.5X3.5;
47. Product No. MWB-2.5X5;
48. Product No. MWB-2X4;
49. Product No. MWB-3X6;
50. Product No. MWB5-1.5x3.5;
51. Product No. WCMB-200-4.
MANUFACTURER Wilson-Cook Medical, Inc., Winston-Salem,
North Carolina.
RECALLED BY Manufacturer, by telephone and by mail on or
about November 5, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,363 units were distributed.
REASON The sheath may separate from the handle
rendering the device inoperable.
_______________
PRODUCT Roche Calibrator Serum a Class II device, is
an in vitro diagnostic calibrator intended for
use on COBAS chemistry instruments with Roche
clinical chemistry reagents. Recall #Z-482-8.
CODE Product Code: 44157, Lot #s 0005 and 0005A EXP
12/1/98.
MANUFACTURER Chiron Diagnostics, Irvine, California.
RECALLED BY Roche Diagnostic Systems, Somerville, New
Jersey, by letter on October 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Israel, Australia, Switzerland.
QUANTITY 1,987 kits (lot 0005) and 493 kits (lot 005A)
were distributed; firm estimates none remains
on the market.
REASON The device does not meet its labeling claim
for six days of stability after
reconstitution.
_______________
PRODUCT Roche Control Serum and Calibrator:
a) Control Serum N, a lyophilized preparation
of human serum used to monitor the accuracy
and precision of clinical chemistry assay
procedures; b) Control Serum P, a lyophilized
preparation of human serum used to monitor the
accuracy and precision of clinical chemistry
assay procedures; c) Calibrator (Human), a
human serum-based calibrator with lot specific
established values for the major constituents
of diagnostic interest commonly measured in
clinical laboratories. Recall #Z-483/485-8.
CODE Lot numbers: a) N3041, N3041A, N3041B;
b) N3141, N3141A; c) T1237, T0941.
MANUFACTURER Boehringer Mannheim, Mannheim, Germany.
RECALLED BY Roche Diagnostic Systems, Somerville, New
Jersey, by letter on March 31, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Amount Shipped:
Control Serum N
lot N3041 - 36 kits
lot N3041A2 - 25 kits
lot N3041B - 62 kits
Control Serum P
lot N3141 - 25 kits
lot N3141A - 67 kits
Roche Calibrator
lot T1237 - 100 kits
lot T0941 - 24 kits.
REASON These control sera and calibrators were
calibrated against an incorrect standard and
yielded results that were 10-15 % higher than
expected.
END OF ENFORCEMENT REPORT FOR APRIL 8, 1998. BLANK PAGES MAY FOLLOW.
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