The manufacturer of an iron supplement has recalled one lot of the product due to bottles of the affected lot potentially containing anti-nausea tablets instead.
Advance Pharmaceutical's lot number 12G468 of Rugby Natural Iron Supplement Ferrous Sulfate may contain 25 mg tablets of meclizine HCl instead of the indicated 325 mg ferrous sulfate tablets.
Meclizine is an over-the-counter and prescription antihistamine used to treat motion sickness and dizziness.
Patients who take the improperly labeled supplements may be at risk for meclizine toxicity, which can cause dose-related serious adverse events, including impaired alertness, drowsiness, confusion, hypotension, coma, and respiratory depression, the company said posted on the FDA's website.
Consumers may also be at serious risk if meclizine is taken with alcohol or other sedatives, if they are older, if they are infants of lactating mothers who received the drug, or if they are newborns whose mothers received the drug immediately before childbirth, the company noted. Others at serious risk include those with a pre-existing central nervous system disorder or impaired liver or kidney function.
"Consumers who take three tablets daily of the defective product for treatment of iron deficiency would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine products," the statement said.
The product is packaged in 100-count bottles with a yellow label.
Customers with affected lots of the product should not consume it and should contact Advance Pharmaceuticals for further information.