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SafetyAlerts
August 23, 2001

Multiple Brands of Liquid Antacid Recalled by York Pharmaceuticals Inc.

Kansas 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 CODE:
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, KY.
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.

CODE:
Lot 0003018, exp. 3/02
Lot 0003048, exp. 3/02
Lot 0006052, exp. 6/02
Lot 0006092, exp. 6/02

MANUFACTURER/RECALLING FIRM:
York Pharmaceuticals, Inc., Kansas City, KS

RECALLED BY:
Manufacturer, by letters on 6/26

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
OK, MS, MO, MD, CA, OR, AR, ND, NY, and OH

QUANTITY:
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.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.