Advance Pharmaceutical Issues Nationwide Voluntary Recall of One Lot of Ferrous Sulfate Tablets
Published: Jan 18, 2013
Consumers who take three tablets daily of the defective product for treatment of iron deficiency will would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Consumption of meclizine three times a day instead of once daily as monograph recommended is likely to lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose. Meclizine toxicity may lead to dose-related serious adverse events, including impaired alterness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatment meclizine toxicity has the potential to be life-threatening.
Consumers who have the affected lot may contact Advance Pharmaceutical with questions at 631-981-4600, Ext.300 on Monday through Friday between 8:30 am and 4:30 pm ET.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.