Advance Pharmaceutical Inc. notified the public of a recall of one lot of ferrous sulfate tablets 325mg, after notification by a pharmacist that a bottle of ferrous sulfate tablets, 325mg contained Meclizine HCl 25mg tablets. The lot of the Rugby Ferrous Sulfate is 12G468. Expiration date for the lot is 07/14.
The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate (see Product Photo page). Meclizine toxicity may lead to dose-related serious adverse events, including impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatmentmeclizine toxicity has the potential to be life-threatening.
BACKGROUND: Taking Meclizine HCl 25mg as ferrous sulfate 325mg 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 take three tablets daily of the defective product for treatment of iron deficiency would be inadvertently ingesting 75mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100mg. 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.
- Source: US Food and Drug Administration