The U.S. Food and Drug Administration (FDA) has announced a recall of iron supplements on Jan. 17. The Advance Pharmaceutical Company has recalled the Rugby Natural Iron Supplement Ferrous Sulfate nationwide because it could contain Meclizine HCI, a medication used to treat or prevent nausea, vomiting and dizziness caused by motion sickness.
The recall was prompted as a result of a pharmacist complaint when it was discovered that Meclizine HCI 25 mg. tablets was found in a bottle meant for Rugby Natural Iron Supplements Ferrous Sulfate, 325 mg.
The two tablets are similar in size – see pictures shown in this article – and can be easily mistaken for the intended one to consume.
The iron supplements will have the expiration date of July 2014 with lot number 12G468.
The direction on the bottles of iron supplements indicates for the user to ingest three times per day. Consumers with the affected product will have ingested 75 mg. of meclizine HCI – the maximum dose is 100 mg. – almost the maximum daily dose requirement for adults.
According to the FDA, “Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.”
Consumers who have the affected product of ferrous sulfate may contact Advance Pharmaceutical at 631-981-4600, extension 300 on Monday through Friday between 8:30 a.m. – 4:30 p.m. Eastern Standard Time.
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Advance Pharmaceutical Issues Nationwide…, U.S. Food and Drug Administration website