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Wrong Medication Prompts Recall

Posted on in Drugs

The Food and Drug Administration (FDA) recently announced a recall for one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, because these tablets may actually contain Meclizine HCl 25 mg tablets. Meclizine HCl is given for the treatment of nausea and vomiting. According to the FDA's press release, ingesting 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.”

The problem was discovered by a pharmacist, who complained to the manufacturer of the Ferrous Sulfate, Advance Pharmaceutical Inc. The company immediately issued a voluntary recall. The tablets were sold with the label Rugby Natural Iron Supplement Ferrous Sulfate in 100 count bottles. The lot of Rugby Ferrous Sulfate is 12G468 and expires on 7/14.

A patient who has been prescribed a daily dosage of three Ferrous Sulfate, but received the defective product, would be actually be taking 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Taking the medication three times per day instead of once per day could also 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. Side-effects of meclizine toxicity include impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. The effects can even become life-threatening.

If you have suffered serious side-effects from being given the wrong drug, contact an experienced Illinois defective product attorney today to find out what compensation you may be entitled to.

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