April 4, 2001Aldroxicon II Double Strength
Antacid/Anti-gas Liquid Recalled
Dale, IL (SafetyAlerts) - The Food
and Drug Administration (FDA) said today that Textilease Medlique has recalled Aldroxicon
II Double Strength antacid/anti-gas liquid because the product exceeded the microbial
limits for release.
This is the first public notice of
this Class II
recall issued by FDA.
(OTC) Aldroxicon II Double Strength antacid/anti-gas liquid, (Aluminum Hydroxide
400 mg, Magnesium Hydroxide 400 mg, Simethicone 40 mg), 30 mL screw cap tubes in units of
10 per box.
Recall # D-147-1.
York Pharmaceuticals, Kansas City, KS. The unit dose packager, Specialty Packaging,
Somerville, NJ, which was responsible for the microbial problem in the product."
Textilease Medlique, Wood Dale, IL., by telephone on 2/23/02. Firm-initiated recall
AL, AZ, CT, GA, IL, LA, ND, OH, TX and WI.
33 cartons of 10 tube each and 227 cartons of 50 tubes.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.