Recalls

Dangerous drug mix-up leads to recall of iron supplement

Recall iron supplement Dangerous drug mix up leads to recall of iron supplement Bottles of Ferrous Sulfate Tablets 325 mg used to treat iron deficiency are being recalled because a pharmacist reported that a bottle of the medication contained Meclizine HCl 25 mg tablets instead. Meclizine is a drug used to treat or prevent nausea, vomiting, and dizziness caused by motion sickness. 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 pre-existing CNS disorders, those with impaired kidney or liver function, the elderly, nursing infants, or lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.

Consumers who take three tables daily of the defective product for the 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. Only one dose per day is recommended for Meclizine, and to consume it three times a day would likely 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. Without treatment, Meclizine toxicity can be life threatening with adverse events including drowsiness, confusion, low blood pressure, coma, and respiratory depression.

The recall affects one lot of Ferrous Sulfate Tablets, 325 mg, Lot 12G468 Exp. 07/14, UPC Barcode 0 0536-5890-01 3. The lot was manufactured and packaged in 100-count bottles by Advance Pharmaceutical Inc., under the label of Rugby Natural Iron Supplement.

Consumers with affected bottles of Ferrous Sulfate Tablets should contact Advance Pharmaceuticals with any questions at 631-981-4600, Ext. 300.

Any side effects with this or any other drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA