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.
December 10, 1997 97-50
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Danish Bakery Larsens Pumpkin Muffins in hard
clear plastic cellophane containers, 16
ounces. Recall #F-134-8.
CODE Pull dates 11-5 through 11-9 inclusive.
MANUFACTURER Larsen Brothers Danish Bakery, Lynwood,
Washington.
RECALLED BY Manufacturer, by telephone on November 5,
1997. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY Approximately 25 packages 4 muffins per
package were distributed.
REASON Product contained undeclared walnuts.
_______________
PRODUCT Cream Cheese and Vegetables packed in plastic
8 ounce cups for retail use, and 8 pound
buckets for bulk use. Recall #F-136-8.
CODE All codes.
MANUFACTURER Rite Foods, Inc., Boston, Massachusetts.
RECALLED BY Manufacturer, by telephone on October 30,
1997, followed by fax, and by press release
on October 31, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Massachusetts, Connecticut, New Hampshire,
Rhode Island, Maine, Vermont, New York,
New Jersey, Pennsylvania.
QUANTITY Approximately 990 cases (12 8-ounce
containers) and 300 8-pound buckets were
distributed.
REASON Product may be contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Margarine/spread under the following labels:
1. Country Crock 12 pack case of 3 lb. tubs; 12
pack case of 1 1/2 lb. tubs; 24 pack case of 1 lb.
tubs; 6 pack case of 5 lb. tubs; 18 pack case of 2
lb. 8 oz. tubs
2. Country Crock Light 12 pack case of 3 lb. tubs
3. Country Crock Churnstyle 12 pack case of 3 lb.
tubs
4. I Can't Believe It's Not Butter! Six pack case
of 3 lb. tubs; 24 pack case of 1 lb. tubs; 18 pack
case of 2 lb. 8 oz. tubs
5. Imperial 6 pack case of 3 lb. tubs
6. I Can't Believe It's Not Butter! Squeeze 18
pack case of 16 oz. bottles
7. Promise Light 24 pack case of 2 lb. 8 oz. tubs
8. Buttermatch 6 pack case of 3 1/2 lb. tubs
9. Kroger 6 pack case of 3 lb. tubs
10. Albertson's Butter 18 pack case of 1 lb. tubs
11. Great Value 12 pack case of 2 lb. tubs; 6 pack
case of 3 lb. tubs
12. Hy-Top 6 pack case of 3 lb. tubs
13. Janet Lee 6 pack case of 3 lb. tubs
14. Morning Fresh 6 pack case of 3 lb. tubs
15. Publix 6 pack case of 3 lb. tubs
16. Albertson's 18 pack case of 1 lb. tubs
17. Shedd's 6 oz. mug
18. Shedd's Liquid 2 1/4 lb. bottle
19. Shedd's Garlic Spread 12 pack case of 1 lb.
tubs
20. Shedd's Whip 20 lb. tub
21. Monarch Whip 20 lb. tub
22. Sysco Whip 20 lb. tub
23. Filberts Stick 30 pack case of 1 lb. Quarters
24. I Can't Believe It's Not Butter! 30 pack case
of 1 lb. Quarters
25. Quarters
-2-
26. Country Crock 30 pack case of 1 lb. Quarters
27. Country Crock Churnstyle 30 pack case of 1 lb.
Quarters
28. Shedd's Spread 30 pack case of 1 lb. Quarters
29. Better Value 30 pack case of 1 lb. tubs
30. Blue Ribbon 30 pack case of 1 lb. tubs
31. Albertson's 30 pack case of 1 lb. Quarters
32. Albertson's 30 pack case of 50 lb. Quarters
33. Publix 30 pack case of 1 lb. Quarters
34. Filberts 8 pack case of 6 lb. tins
35. NIFDA 30 pack case of 1 lb. Solids
36. Nugget 30 pack case of 1 lb. Solids
37. Pocahontas 30 pack case of 1 lb. Solids
38. All Kitchen 30 pack case of 1 lb. Solids
39. Blue Ribbon 30 pack case of 1 lb. Solids
40. Frosty Acres 30 pack case of 1 lb. Solids
41. Shedd's 30 pack case of 1 lb. Solids
42. Country Crock 5 gm
43. Country Crock 14 gm
44. Blue Ribbon 5 gm
45. Sysco Farm Fresh 5 gm, 14 gm
46. Country Crock and Honey 10 gm
47. Promise 5 gm. Recall #F-139/185-8.
CODE Date Codes DEC1697A, DEC1797A, and DEC1897A.
MANUFACTURER Lipton Foods, Atlanta, Georgia.
RECALLED BY Manufacturer, by fax on June 26, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Florida, Indiana, Kentucky,
Massachusetts, North Carolina, Pennsylvania, Ohio,
South Carolina, Tennessee, Virginia, Puerto Rico.
QUANTITY 51,798 cases were distributed.
REASON The products were processed under insanitary
conditions whereby they may become injurious to
health.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Great Value brand Frozen Concentrated Orange
Juice, in 12 fluid ounce plastic "cans".
Recall #F-135-8.
CODE B7210.
MANUFACTURER Citrus Belle, LaBelle, Florida.
RECALLED BY Manufacturer, by telephone on September 29,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Midwest and Southeast United States.
QUANTITY Approximately 63,000 units were distributed.
REASON Product is contaminated with sand.
-3-
_______________
PRODUCT Izalco Cebada Rosada (Pink Barley Drink Mix),
in 12 ounce containers. Recall #F-137-8.
CODE None.
MANUFACTURER Abeco Alimentos & Bebidas, La Libertad,
El Salvador.
RECALLED BY Cacique Foods, Inc., Jersey City, New Jersey,
by letter dated August 20, 1997. Ongoing
recall resulted from sample analysis and
followup by the New York Department of
Agriculture and Markets.
DISTRIBUTION Nationwide.
QUANTITY Approximately 100 cases (24 packages per case)
were distributed; firm estimated that 10
percent of product remained on market at
time of recall initiation.
REASON Product contains undeclared FD&C Red No. 40
and Red No. 3.
______________
PRODUCT Ferrara brand Grenadine Syrup packed in
26.4 fluid ounce plastic bottles with
white plastic screw on caps.
Recall #F-138-8.
CODE None. All product distributed 6/96 through
1/97.
MANUFACTURER Colavita USA, Inc., Linden, New Jersey.
RECALLED BY Manufacturer, by letter February 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION New York and New Jersey.
QUANTITY 85 cases (1,020) units were distributed;
firm estimates none remains on the market.
REASON Product contained undeclared FD&C Red No. 40.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Red Blood Cells
b) Red Blood Cells-Leukocytes Removed
c) Platelets; d) Fresh Frozen Plasma.
Recall #B-262/265-8.
CODE Unit numbers: a) 10491-6125, 10506-3479
b) 10502-1846; c) 10502-1846, 10506-3479
d) 10491-6125.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona,
by letter dated July 9, 1996, and January 15,
1997. Firm-initiated recall complete.
DISTRIBUTION Arizona.
-4-
QUANTITY a) 2 units; b) 1 unit; c) 2 units; d) 1 unit was
distributed.
REASON Blood products were collected from a donor whose
health history screening was inadequately
performed.
_______________
PRODUCT Red Blood Cells. Recall #B-281-8.
CODE Unit #KR96959.
MANUFACTURER The Blood Center of Central Iowa, Des Moines,
Iowa.
RECALLED BY Manufacturer, by letter dated June 6, 1997.
Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported travel to an area designated as endemic
for malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-282-8.
CODE Unit #LC21805.
MANUFACTURER The Blood Center of Central Iowa, Des Moines,
Iowa.
RECALLED BY Manufacturer, by telephone on March 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
was not tested for syphilis.
_______________
PRODUCT Platelets. Recall #B-286-8.
CODE Unit #KE53960.
MANUFACTURER The Blood Center of Central Iowa,
Des Moines, Iowa.
RECALLED BY Manufacturer, by telephone and by letter dated
July 20, 1993. Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative 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.
_______________
PRODUCT Red Blood Cells. Recall #B-287-8.
CODE Unit #KT85533.
MANUFACTURER The Blood Center of Central Iowa,
Des Moines, Iowa.
-5-
RECALLED BY Manufacturer, by letter dated June 6, 1997.
Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
who reported travel to an area designated
as endemic for malaria.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-289/290-8.
CODE Unit #8144243.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated September 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a tattoo within 12 months of donation.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-291/292-8.
CODE Unit #7833339.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated September 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
was exposed to blood of two different people.
_______________
PRODUCT Platelets. Recall #B-293-8.
CODE Unit #24FH11763.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by telephone on September 11, 1997,
and by letter dated November 14, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-266-8.
CODE Unit # 10502-1846, 10506-3479.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
-6-
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona,
by letter on July 9, 1996. Firm-initiated
recall complete.
DISTRIBUTION Switzerland.
QUANTITY 2 units were distributed.
REASON Blood product was collected from a donor
whose health history screening was
inadequately performed.
_______________
PRODUCT Red Blood Cells. Recall #B-288-8.
CODE Unit #KC94403.
MANUFACTURER The Blood Center of Central Iowa,
Des Moines, Iowa.
RECALLED BY Manufacturer, by telephone on May 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Concentrate Bicarbonate Dialysate, labeled for use
only with acid concentrate solution in a 3-stream
proportioning artificial kidney equipment using
Purified Water (AAMI Standard RD5).
Recall #Z-205-8.
CODE Lot numbers 714043C and 716341C.
MANUFACTURER Gambro Healthcare, DeLand, Florida.
RECALLED BY Manufacturer, by letter mailed on August 30, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Florida, Pennsylvania, New York, Tennessee,
Georgia, Ohio, New Jersey, Iowa, Massachusetts,
California, South Carolina, Virginia, North
Carolina, Kansas, Texas, Nebraska.
QUANTITY 933 cases were distributed.
REASON The bags are mislabeled as "BP-001-15"(product
which yields 15 gallons of liquid bicarbonate)
when in fact the bags contain "BP-001-25" (product
which yields 25 gallons of liquid bicarbonate).
_______________
PRODUCT B & F Medical Disposable Home Ventilator Circuits,
used in conjunction with Life Products and
Lifecare Ventilators, to provide respiratory
therapy for individuals receiving in-home patient
care:
a) Model No. 64673; b) Model No. 64677;
c) Model No. 64693; d) Model No. 64694;
-7-
e) Model No. 64698; f) Model No. 64699.
Recall #Z-206/211-8.
CODE The recalled ventilator circuits are identified
with six digit lot numbers, the first four digits
of which are: 2747 through 3047.
MANUFACTURER Allied Healthcare Products, Inc., doing business
as, B & F Medical Products, Disposable Products
Division, Toledo, Ohio.
RECALLED BY Manufacturer, by letter on November 11, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 7,230 circuits were distributed.
REASON The devices may have small particles of
polyethylene plastic in the exhalation valve
connector tee.
SEIZURES: =================================================
_______________
PRODUCT Frozen Shrimp (97-768-221).
CHARGE Adulterated -- Decomposition.
LOCATION Americold Corporation, Tampa, Florida.
FILED November 26, 1997 - U.S. District Court for
the Middle District of Florida, Tampa
Division; Civil No. 97- 2826-CIV-T-26C,
FDC 67215.
SEIZED November 26, 1997 -- 555 cases valued at
$30,000.
_______________
PRODUCT Liquid Oxygen USP stored in a bulk stand tank
and in cryogenic vessels and home units
(DOC 97-557-804).
CHARGE Adulterated -- good manufacturing practice
violations. Misbranded -- labels fail to
bear adequate directions for use and the
prescription legend, "Caution: Federal
law prohibits dispensing without prescription."
LOCATION Praxair Distribution, Inc., Mankato, Minnesota.
FILED October 16, 1997 - U.S. District Court for the
District of Minnesota; Civil No. 97-2310;
FDC 67207.
SEIZED October 22, 1997 - Goods valued at $95,468.
-8-
END OF ENFORCEMENT REPORT FOR DECEMBER 10, 1997. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
![[FDA HOME PAGE]](/icon/iconhome.gif)