|
FDA Recalls & Court
Actions
|
March 9,
2005
|
|
CLASS II
|
|
Majestic Royal Jelly
|
|
1000 mg. Plus
Ginseng, Made in the U.S.A., in bottles of 10 capsules
and 30 capsules per bottle. Lot no. 1005004, NFS Code
no. 1516-C, Exp 10/2007.
|
|
Manufacturer:
|
Nutritional
Food Supplements, Copiague, NY.
|
|
Recalled
by:
|
Manufacturer,
by telephone, fax and mail on or about Dec. 20, 2004.
Firm-initiated recall is complete.
|
|
Distribution:
|
Jordan; 1,400
bottles (30 capsules per bottle) and 700 bottles (10
capsules per bottle).
|
|
Reason:
|
The ginseng
powder raw material supplied to the firm was found to
be contaminated with pesticides.
|
|
Recall
number:
|
F-194-5.
|
|
Similac
Advance with Iron Formula Powder
|
|
12.9 oz. can.
The product is packaged as 6 cans per case for delivery
to retail stores. Lot number "20307RB" containing use
by date f "1 SEP 2006" printed on the bottom of
individual cans. The product can list number is 55958.
The product case list number is 55957.
|
|
Manufacturer:
|
Ross Products
Division, Abbott Laboratories, Columbus, OH.
|
|
Recalled
by:
|
Manufacturer,
by letter on Feb. 2, 2005. Firm-initiated recall is
ongoing.
|
|
Distribution:
|
Nationwide;
82,986 cans.
|
|
Reason:
|
The product
may contain rigid polyvinyl chloride plastic (PVC)
foreign material.
|
|
Recall
number:
|
F-198-5.
|
|
CLASS III
|
|
Effervescent Antacid and Pain
Medication
|
|
Aspirin 325
mg, citric acid 1000 mg and sodium bicarbonate 1916 mg,
in 36 and 72 effervescent tablet packages packaged
under Good Sense brand. Also sold under other brands
as: American Fare brand; Eckerd brand; Equate brand;
Family Dollar brand; Kroger brand; Major brand; Meijer
brand; Pathmark brand; Rite Aid brand; Safeway brand;
Today's Health brand; Top Care brand, and Western
Family brand. Lots 3EP0066, 3EP0067, 3EP0074, 3EP0075,
3EP0076, 3FP0001, 3FP0002, 3FP0003, 3FP0076, 3GP0001,
3GP0002, 3GP0026.
|
|
Manufacturer:
|
Perrigo
Company, Allegan, MI.
|
|
Recalled
by:
|
Manufacturer,
by letter dated Feb. 23, 2005. Firm-initiated recall is
ongoing.
|
|
Distribution:
|
Nationwide;
109,804 packages.
|
|
Reason:
|
Stability
Failure: The product exceeded the firm's specification
for salicylic acid at the 18 month stability
period.
|
|
Recall
number:
|
D-141-5.
|
|
Junior's
chewable tablets
|
|
Acetaminophen
160 mg, USP in 20-tablet bottles, bubblegum flavor
labeled as Life brand, OTC, Lots 3KE0967, 3KE0674,
4AE0013, 4AE0775 and 4BE0421; Exp. 09/15/2005.
|
|
Manufacturer:
|
Perrigo
Company, Allegan, MI.
|
|
Recalled
by:
|
Manufacturer,
by telephone on Feb. 4, 2005 and by fax on Feb. 16,
2005. Firm-initiated recall is ongoing.
|
|
Distribution:
|
Canada;
50,268 bottles.
|
|
Reason:
|
Dissolution
Failure.
|
|
Recall
number:
|
D-139-5.
|
|
EDITORS' NOTE:
Tabulation prepared from information provided by
FDA. The agency has three classes of recalls. Class
I - violative product poses reasonable probability
of serious adverse health consequences or death;
Class II - violative product may cause temporary or
medically reversible adverse health consequences;
probability of serious consequences remote; Class
III - violative product not likely to cause adverse
health consequences. Editors of "The Tan Sheet"
appreciate hearing from any company that would like to
provide additional information on any recall listed in
a weekly tabulation.
|
