FDA Safety Alert
alerting consumers, pharmacy and health care professionals to a
nationwide recall of one lot of 81 mg Enteric Coated Aspirin Tablets
because of the possibility that the tablets in these bottles may
actually contain tablets with 500 mg of acetaminophen, the active
ingredient in other pain relievers such as Tylenol. The aspirin,
intended for the treatment of minor aches and pains, was manufactured
and packaged by Advance Pharmaceutical Inc. under the label of Rugby
Risk: Consumers who inadvertently
take 500 mg of acetaminophen are at risk of severe liver damage if they
take other drugs containing acetaminophen, consume three or more
alcoholic drinks every day, or have liver disease. The label directions
on the mislabeled products instruct patients to take four to eight
tablets every four hours, but not more than 48 tablets in 24 hours.
Consumers who take 48 tablets daily of the defective product may be
ingesting up to 24,000 mg of acetaminophen, which is six times the
maximum recommended daily dose. The affected lot Enteric Coated Aspirin
Tablets is Lot 13A026 with an expiration date of January 2015.
who have the affected lot should immediately discontinue its use and
return it to the pharmacy or store where it was purchased.
should contact their physician or health care professional if they have
experienced any problems that may be related to taking or using this
product. Signs of liver damage include abdominal pain and swelling,
yellowish discoloration of the skin and eyes, and dark urine.
- Consumers with questions may contact Advance Pharmaceutical Inc., Monday-Friday, 9 a.m.-5 p.m. ET at 631-981-4600, Ext. 308.
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