Chase Laboratories And Geneva Generics Recall Prenatal Vitamins With Folic Acid Due To Potential Iron Toxicity Hazard

Description

March 10, 1992 Release # 92-061 Chase Laboratories And Geneva Generics Recall Prenatal Vitamins With Folic Acid Due To Potential Iron Toxicity Hazard PRODUCT: "Prenatal Vitamins with Folic Acid" by Chase Laboratories under the Geneva Generics label, containing 100 tablets of vitamins with iron. PROBLEM: Lack of child-resistant closure means that a child could accidentally swallow these vitamins with iron. Just four or five tablets if consumed by a child at one time can cause serious illness or death. WHAT TO DO: Immediately return the "Prenatal Vitamins with Folic Acid" (100-tablet bottles) to the store where purchased for a refund of the purchase price. WASHINGTON, DC - In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Chase Laboratories, Inc. of Newark, NJ is voluntarily recalling their 100 tablet bottles of "Prenatal Vitamins with Folic Acid" packaged under the Geneva Generics label because they are not packaged with child-resistant closures. The product intended for pregnant or lactating women, contains 60 milligrams of iron per tablet. The iron contained in just four or five tablets, if consumed by a child at one time, can cause serious illness or death. The recalled Prenatal Vitamins contain 100 tablets with a total of 6,000 milligrams (mg) of iron. The package is not child-resistant as required by the Poison Prevention Packaging Act. The CPSC enforces the requirement that any over-the-counter medication or dietary supplement which contains more than 250 mg of iron in a single package must be supplied with child- resistant packaging. Chase Laboratories reported the packaging problem and their initiation of the recall to CPSC under the reporting requirements of Section 15(b) of the Consumer Product Safety Act, 15 U.S.C. {2064(b). Consumers should immediately return the product to the store where purchased for a refund of the purchase price. Since the product's introduction in 1990, approximately 70,000 bottles of Prenatal Vitamins with Folic Acid packaged under the Geneva Generics Label were distributed in non-child-resistant packaging through 342 retail and wholesale druggists nationwide. Chase Laboratories, the manufacturer, and Geneva Generics, the private label distributor, instituted the recall of this product because of the potential hazard to children from these tablets due to the lack of child- resistant packaging. Neither of the recalling firms nor the Commission is aware of any poisoning incidents due to this product. Data from the American Association of Poison Control Centers report that 11 children in the United States died in 1991 from ingestion of iron-containing medicines and dietary supplements. CPSC is announcing this recall as part of its mission to protect the public from unreasonable risks of injury and death associated with consumer products. The Commission's objective is to reduce the estimated 28.5 million injuries and 21,600 deaths associated each year with the 15,000 different types of consumer products under CPSC's jurisdiction