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MyKidz Iron 10 FDA Alerts

The FDA Alerts below may be specifically about MyKidz Iron 10 or relate to a group or class of drugs which include MyKidz Iron 10.

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for MyKidz Iron 10

Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall - Bottle May Contain Meclizine HCl 25 mg Tablets

ISSUE: Advance Pharmaceutical Inc. notified the public of a recall of one lot of Ferrous Sulfate Tablets 325 mg, after notification by a pharmacist that a bottle of Ferrous Sulfate Tablets, 325 mg contained Meclizine HCl 25 mg 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 treatment meclizine toxicity has the potential to be life-threatening.

BACKGROUND: 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 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 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.

RECOMMENDATION: Consumers who have the affected lot should not take the product. They may contact Advance Pharmaceutical with questions at 631-981-4600, Ext.300, Monday through Friday between 8:30 am and 4:30 pm ET.

[01/17/2013 - Press Release - Advance Pharmaceutical]
[01/17/2013 - Product Photos - FDA]

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