August 23, 2001Multiple Brands of Liquid Antacid Recalled by York Pharmaceuticals
City, KS (SafetyAlerts) - The Food
and Drug Administration (FDA) said today that York Pharmaceuticals, Inc. is recalling
multiple brands of liquid antacid because of total aerobic microbial count failures
and lack of preservative effectiveness testing.
This is the first public notice of
this Class II
recall issued by the FDA.
RECALL NUMBER, PRODUCT AND
1. D-283-1, Regular strength liquid antacid packaged in 1-gal. jugs and 12-fl.
oz. bottles, each 5-ml. tsp. contains 200-mg. aluminum hydroxide (equiv. to dried gel,
USP), 200-mg. magnesium hydroxide, and 20-mg.
simethicone. Product is packaged and distributed in the 12-fl. oz. size under the
following labels and sizes:
a. York Antacid Liquid with
Simethicone Antacid - Anti-Gas Original Flavor, 1-gal. container, Lot 0006052. The
responsible firm on the label shows the product is manufactured by York Pharmaceuticals,
Inc., Kansas City, KS.
b. ShurFine Fast Acting Antacid Anti-Gas Original, 12-fl. oz. bottles, Lot 0003018.
Distributed by Shurfine International, Inc., Northlake, IL.
c. Dollar General Regular Strength Fast Acting Antacid Liquid Antigas/Antacid
Original, 12-fl. oz. bottles, Lot 0006052. Distributed By Dolgencorp, Inc., Scottsville,
d. Smart Choice Liquid Antacid Plus Simethicone, 12-fl. oz. bottles, Lot 0006052.
Distributed by National Distribution Network, Merrick, NY.
2. D-284-1, Maximum strength liquid
antacid packaged in 1-gal. jugs and 12-fl. oz. bottles, each 5-ml. tsp. contains 400-mg.
aluminum hydroxide (equiv. to dried gel, USP), 400-mg. magnesium hydroxide, and 40-mg.
simethicone, indicated for use in heartburn, acid indigestion, sour stomach, associated
symptoms of gas and upset stomach, overindulgence in food and drink.
a. York Extra Strength Antacid
Suspension with Simethicone Antacid - Anti-Gas Original Flavor, 1-gal. jug, Lot 0006092.
Manufactured by York Pharmaceuticals, Inc., Kansas City, KS.
b. Rite Aid Fast Acting Antacid & Anti-gas Maximum Strength Original, 12-fl.
oz. bottles, Lot 0003048. Distributed by Rite Aid Corporation, Harrisburg, PA.
c. Select Brand Maximum Strength Fast Acting Antacid Anti-Gas Original, 12-fl. oz.
bottles, Lot 0006092. Distributed by Select Brand Distributing, Pine Bluff, AR.
d. Discount Drug Mart Food Fair Maximum Strength Fast Acting Antacid Liquid Original
Flavor, 12-fl. oz. bottles, Lot 0006092. Distributed by Drug Mart-Food Fair, Medina, OH.
Lot 0003018, exp. 3/02
Lot 0003048, exp. 3/02
Lot 0006052, exp. 6/02
Lot 0006092, exp. 6/02
York Pharmaceuticals, Inc., Kansas City, KS
Manufacturer, by letters on 6/26
FIRM INITIATED RECALL:
OK, MS, MO, MD, CA, OR, AR, ND, NY, and OH
The following approx. amounts were dist: Lot 0003018 - 965/12/12-fl. oz. btl cs; Lot
0003048 - 260/12/12-fl. oz. btl cs; lot 0006052 - 1,826/12/12-fl. oz. btl cs and
135/4/1-gal. jug cs; lot 0006092 - 502/12/12-fl. oz. btl cs and 132/4/1-gal jug cs
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.