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Safety Alerts
June 24, 1998

Product
Generic and private label forms of over-the-counter liquid medications:

a) Milk of Magnesia (Magnesium Hydroxide 400 mg), in 12 fluid ounce bottles;

b) Tussin DM (Guaifenesin, USP 100 mg/Dextromethorphan Hydrobromide, USP 10 mg), in 4 fluid ounce bottles;

c) Nite Time Adult (Acetaminophen, USP 1000 mg/Dextromethorphan Hydrobromide, USP 30 mg/Pseudoephedrine Hydrochloride, USP 12.5 mg), in 6 fluid ounce bottles;

d) Pink Bismuth (Bismuth Subsalicylate 262 mg per 30 ml), in 12 fluid ounce bottles;

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

f) Antacid Liquid (Magnesium Hydroxide/Aluminum Hydroxide), in 12 fluid ounce bottles.

Recall #D-161/163 & 165/168-8.

CODE
All lot numbers.

MANUFACTURER
OTC Technologies, Inc., Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter on May 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Michigan, California, Mississippi, North Carolina, Florida.

QUANTITY
Approximately 14,214 cases (12 units per case) were distributed.

REASON
Good manufacturing practice and formulation deviations (reduced or lack of active ingredients).

 

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.