FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
01/06/1993
RECALLS AND FIELD CORRECTIONS: January 6, 1993
FOODS -- CLASS I 93-1
PRODUCT El Ranchito Queso Fresco, soft Mexican Cheese. RecallF-161-3.
CODE Violative code is NOV 28. However, the firm has recalled all
codes of product.
MANUFACTURER Country Morning Farms, Othello, Washington.
RECALLED BY El Ranchito, Zillah, Washington, by visits of October 14
through 19, 1992. Firm-initiated recall complete.
DISTRIBUTION Washington state and Oregon.
QUANTITY Firm estimates none remains on the market.
REASON The product contains Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Yogurt, Sour cream, and guacamole dip packed under Kroger Lite,
Homeland, and Westover labels:
(a) Kroger Lite Lemon Yogurt, in 8 ounce plastic containers;
(b) Kroger Lite Strawberry Yogurt, in 8 ounce plastic
containers;
(c) Kroger Lite Cherry Vanilla, in 8 ounce plastic containers;
(d) Kroger Lite Pina Colada Yogurt, in 8 ounce plastic
containers;
(e) Kroger Sour Cream, in 24 ounce plastic containers;
(f) Kroger Guacamole Dip, in 8 ounce plastic containers;
(g) Westover Dairy Sour Cream, in 16 ounce plastic containers;
(h) Homeland Sour Cream, in 16 ounce plastic containers.
RecallF-148/155-3.
CODE Kroger Lite Yogurts - OCT 31 481215;
Kroger Sour Cream - OCT 16 481215;
Homeland Sour Cream - OCT 15 481215;
Kroger Guacamole Dip - NOV 15 481215.
MANUFACTURER The Kroger Company, doing business as Vandervoort's Dairy Foods
Company, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone September 17, 1992, and by letter
September 18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Oklahoma and Texas.
QUANTITY 113 cases of the 8 ounce yogurt, 19 cases of the 24 ounce sour
cream, 29 cases of the 16 ounce sour cream, and 17 cases of the
8 ounce guacamole dip were distributed; firm estimates none
remains on the market.
REASON Product is contaminated with metal cutter pieces.
UPDATE Shucks Butter Popcorn, RecallF-133-3 manufactured by Golden
Harvest Popcorn Company, a Class II recall which appeared in
the December 23, 1992 Enforcement Report should read:
Reason: Product contains undeclared FD&C Yellow5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Nalley's Fine Foods brand: (a) Mayonnaise, in 32 ounce glass
jars; (b) French Dressing, in 16 fluid ounce plastic bottles.
RecallF-156/157-3.
CODE (a) 0 92 18 21 Buy Before Jan 10, 1993; (b) Best When Purchased
Before Apr 9, 1993.
MANUFACTURER Nalley's Fine Foods, Tacoma, Washington.
RECALLED BY Manufacturer, by telephone October 7, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Washington state, Utah, Idaho, Alaska, Oregon
QUANTITY (a) 774 cases (12 bottles per case); (b) 1,115 cases (12
bottles per case) were distributed.
REASON Products are contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Whole Blood for further manufacturing use. RecallB-038-3.
-2-
CODE Unit s were not identified with unit numbers. The donor's name
(last name, first name) was handwritten on the label. The
following is a listing of the donors' initials only (last,
first & middle): LRD, KSM, TSJ, GRD, OKP, GHU, PTR, LCA, MJM,
HAG, CPA, GLR, WSU, LJC, SMA. All 15 units were collected in
Fenwal Bags with bag lot number F125799.
MANUFACTURER M.D. Laboratories, San Diego, California.
RECALLED BY Manufacturer, by telephone July 17, 1992, followed by letter
July 20, 1992. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 15 units.
REASON Blood products, not collected in accordance with good
manufacturing practices, were distributed.
PRODUCT Red Blood Cells. RecallB-039-3.
CODE Unit numbers: 53G57453, 53GL37560, 53GZ37648, 53KN36288,
53KN36289, 53KN36297, 53KN36298, 53KN36301.
MANUFACTURER American Red Cross Blood Services, Greater Chesapeake and
Potomac Region, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone October 28, 1991. Firm-initiated
recall complete.
DISTRIBUTION Washington, D.C., Maryland.
QUANTITY 8 units.
REASON Blood products, corresponding to units of Platelets which were
implicated in a case of post-transfusion Escherichia coli
(E.coli) septicemia, were distributed.
PRODUCT Platelets. RecallB-046-3.
CODE Unit 50G85540.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone March 24, 1991, followed by letter
April 27, 1991. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood products, corresponding to units implicated in a case of
post transfusion Yersinia enterocolitica infection, were
distributed.
PRODUCT Platelets. RecallB-048-3.
CODE Unit49G03143.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone February 28, 1991. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood products, which correspond to a unit of Red Blood Cells
which was implicated in a case of post-transfusion Yersinia
enterocolitica septicemia, were distributed.
-3-
PRODUCT Platelets. RecallB-101-3.
CODE Unit numbers: 6T3049, 6T3051, 6T3062, 6T3064, 6Z9038, 6Z9048,
6Z9050, 6Z9058, 6Z9062, 6Z9064, 6Z9066, 6Z9068.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Consignee notified firm April 21, 1992. Firm-initiated recall
complete.
DISTRIBUTION Washington state.
QUANTITY 12 units.
REASON Blood products which were labeled with incorrect expiration
dates were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Recovered Plasma. RecallB-040-3.
CODE Unit numbers: 53G57453, 53GL37560, 53GZ37648, 53NK36288,
53KN36289, 53KN36297, 53KN36298, 53KN36301.
MANUFACTURER American Red Cross Blood Services, Greater Chesapeake and
Potomac Region, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone October 28, 1991. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 8 units.
REASON Blood products, corresponding to units of Platelets which were
implicated in a case of post-transfusion Escherichia coli (E.
coli) septicemia, were distributed.
PRODUCT Recovered Plasma. RecallB-047-3.
CODE Units 50G85540 and 50G85543.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone March 24, 1991, followed by letter
April 17, 1991. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 2 units.
REASON Blood products, corresponding to units implicated in a case of
post transfusion Yersinia enterocolitica infection, were
distributed.
PRODUCT Recovered Plasma. RecallB-049-3.
CODE 49G03143.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone February 27, 1991. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood products, which correspond to a unit of Red Blood Cells
was implicated in a case of post-transfusion Yersinia
enterocolitica septicemia, were distributed.
-4-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Wavicide-01 Sterilizing and Disinfecting Solution, in 1 gallon
containers. RecallZ-172-3.
CODE Lot numbers: 02-118 through 02-192 and 02-1121 through 02-293.
MANUFACTURER Wave Energy Systems, Cedar Grove, New Jersey.
RECALLED BY Manufacturer, by letter August 5, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Europe.
QUANTITY 13,664 cases of 2% solution and 336 55-gallon drums of 20%
solution.
REASON Due to variability of the testing methodology, the 0.5%
glutaraldehyde (1:4 dilution) tuberculocidal claim has been
deleted from the labeling. The product should be used
full-strength as instructed on the label.
PRODUCT Colgate Sterall Sterilizing and Disinfection Solution, in 1
gallon containers, a re-usuable sterilizing and disinfection
solution, brand of potentiated glutaraldehyde. RecallZ-173-3.
CODE All lots.
MANUFACTURER Colgate Hoyt/Gel-Kam, Dallas, Texas;
Concentrate (sterall) (initial registrant) -- Wave Energy,
Cedar Grove, New Jersey
RECALLED BY Colgate Hoyt/Gel-Kam, Division of Colgate-Palmolive Company,
Canton, Massachusetts, by letter August 3, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Based on new preliminary testing, the usage instructions for
the solution diluted 1:4 (0.5% Glutaraldehyde) for
tuberculocidal use have been deleted. The product should be
used full strength as instructed on the label.
PRODUCT Barrel Bur (6.1 mm), Part1607-2-1, a cutting accessory for
orthopedic bone drill. RecallZ-174-3.
CODE Lot92080331.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter September 18, 1992. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 box of 3 products was distributed.
REASON Each box containing 3 burs may not contain a warning insert
sheet, which includes a caution on limited speed bur operation.
PRODUCT Constavac Radiopaque Wound Drains (3/16"), Part215-31 and
(1/4") Part215-32. RecallZ-175/176-3.
CODE Lot92041062 for both sizes.
MANUFACTURER Stryker Puerto Rico, Arroyo, Puerto Rico.
RECALLED BY Stryker Corporation, Instruments Division, Kalamazoo, Michigan,
by letter June 29, 1992. Firm-initiated recall complete.
-5-
DISTRIBUTION California, Florida, Iowa, Virginia, New Jersey, New Mexico,
Texas.
QUANTITY 15 units of part215-31 and 3 units of Part215-32 were
distributed.
REASON There is an inordinate amount of excess silicone adhesive
blocking the tubing at the trocar end of the wound drain.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Certified Wright's Stain Solution, an in-vitro diagnostic
device used as a biological stain, for staining blood smears
for microscopic examination of cell morphology and differential
counting. RecallZ-171-3.
CODE CatalogSW16-1, lotDS1057 EXP 9/1/94.
MANUFACTURER American Biological Technologies (AbT), Seguin, Texas.
RECALLED BY Manufacturer, by letter October 23, 1992. Firm-initiated
recall complete.
DISTRIBUTION Delaware, Illinois, New Jersey.
QUANTITY 144 bottles were distributed; firm estimates none remains on
the market.
REASON The product was labeled with incorrect expiration date of
01SEP94. The correct expiration date is 01SEP93.
PRODUCT Mandibular Osteotomy Blade, Aggressive, 5.0 mm cut edge,
Part277-31-52. RecallZ-177-3.
CODE 10911191.
MANUFACTURE