September 20, 2000Aluminum Hydroxide Gel, USP,
SC (SafetyAlerts) - The Food and
Drug Administration (FDA) has announced that Pharmaceutical Associates, Inc., is recalling
certain lots its Aluminum Hydroxide Gel, USP, Antacid because of resuspension problems.
This is the first public notice of
this Class III
recall issued by FDA.
Aluminum Hydroxide Gel, USP, Antacid, 320 mg/5mL, mint flavor, in 12 and 16-fluid
Lot Numbers: 9I13 and 9I11.
Pharmaceutical Associates, Inc., Greenville, South Carolina.
Manufacturer, by letter on February 28, 2000. Firm-initiated recall **complete.
**Completed recall: While the FDA has completed
processing of this particular recall, it does not mean this particular product has been
fully accounted for.
6,000 16-ounce and 8,359 12-ounce bottles were distributed.
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