June 24, 1998
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.
All lot numbers.
OTC Technologies, Inc., Atlanta, Georgia.
Manufacturer, by letter on May 1, 1998. Firm-initiated recall ongoing.
Michigan, California, Mississippi, North Carolina, Florida.
Approximately 14,214 cases (12 units per case) were distributed.
Good manufacturing practice and formulation deviations (reduced or lack of active