A recall has been issued for Rugby Natural Iron Supplement tablets, after a pharmacist found the wrong drugs inside of a bottle.
The Rugby Natural Iron Supplement recall was announced by the FDA on January 17, after at least one complaint was received by the manufacturer, Advance Pharmaceutical Inc., indicating that a bottle was filled with Meclizine tablets, which are sold under the brand names Dramamine, Bonine, Postafen, Sea Legs, Meclozine and Antivert. There have been no adverse events or injuries reported in connection with the recall.
Rugby Natural Iron Supplements are ferrous sulfate tablets, but the tablets found inside the bottle, Meclizine HCI 25 mg, could cause serious side effects to those taking sedatives or consuming alcohol, as well as to those with a pre-existing CNS disorder, those who have kidney or liver problems, and could also harm the elderly or infants nursing on mothers who were given the drugs immediately after childbirth.
Meclizine is an antihistamine usually prescribed to treat nausea, motion sickness and some forms of vertigo. The iron supplement pills are designed to be taken three times daily, and taking the Meclizine three times a day would put the consumer near the maximum daily dose of 100 mg. It is a long-acting drug that builds up inside the body and whose affects could last up to 24 hours. Other side effects can include impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. The FDA and Advance Pharmaceutical warn that toxicity from the drug could build to life-threatening levels.
The recall affects Ferrous Sulfate Tablets, 325 mg, with a lot number of 12G468, and an expiration date of 07/14. They were sold under the Rugby Natural Iron Supplement label and have a UPC barcode of 0 0536-5890-01 3. The recalled lot was sold in 100 count bottles.
Consumers with questions or who have an affected lot can contact Advance Pharmaceutical with questions at (631) 981-4600, ext. 300.