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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 13, 1998

PRODUCT
Various OTC products, distributed under generic and various brand names including Health Care, Pharmacy Classics, Personal Care, and Equality Health Care:

a) Liquid Antacid (Magnesium Hydroxide 200 mg/Aluminum Hydroxide 200 mg) in 12 fluid ounce bottles

b) Liquid Antacid with Simethicone (Magnesium Hydroxide 200 mg/Aluminum Hydroxide 200 mg/Simethicone 20 mg), in 12 fluid ounce bottles

c) Children's Acetaminophen Elixir (Acetaminophen 160 mg) cherry flavored in 4 fluid ounce bottles

d) Sore Throat Spray (Phenol 1.4%) alcohol/sugar free, in 6 fluid ounce bottles

e) Children's Night Time (Dextromethorphan Hydrobromide 15 mg/Chlorpheniramine Maleate 2 mg/Pseudoephedrine Hydrochloride 30 mg), in 6 fluid ounce bottles

f) Nightime(Nite Time) for Adults (Acetaminophen 1000 mg/Dextromethorphan Hydrobromide 30 mg/Doxylamine Succinate;

g) Pink Bismuth (Bismuth subsalicylate 262 mg/tablespoon) in 6 fluid ounce bottles

h) Pediatric Tussin (Dextromethorphan Hydrobromide 7.5 mg) in 4 fluid ounce bottles

i) Tussin Syrup/Tussin DM (Guaifenesin USP 100 mg/Dextromethorphan Hydrobromide USP 10 mg) in 4 fluid ounce bottles

j) Milk of Magnesia (Magnesium Hydroxide 400 mg) in 12 fluid ounce bottles.

Recall #D-121/130-8.

CODE
All lots on the market within expiration date.

MANUFACTURER
South Atlantic Industries, Inc., Greenville, South Carolina.

RECALLED BY
Manufacturer, by letter on or about April 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Michigan, Mississippi, North Carolina, Georgia, California, Ohio, Illinois, New York.

QUANTITY
Undetermined.

REASON
Lack of good manufacturing practice controls.

 

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.