FOR IMMEDIATE RELEASE
February 17, 1994
Release # 94-038
PRODUCT: Approximately 4,435 bottles of Fem-Plus" nutritional supplements for women by Enzymatic Therapy, Inc. The recalled Fem-Plus were sold in white, opaque plastic bottles with blue screw-on plastic caps from 6/1/93 through 8/2/93. Each bottle contains 60 capsules with 25 milligrams (mg) of iron per capsule.
PROBLEM: Because of its iron content, Fem-Plus must be sold in child-resistant packaging. The recalled bottles lack the required packaging. A child could easily open the bottle and ingest too much iron, leading to serious illness or death.
WHAT TO DO: Return unused portions of any bottles to the place of purchase for a replacement or full refund. Consumers may call 1-800-783-2286.
WASHINGTON, DC --- CPSC, Enzymatic Therapy, Inc., of Green Bay, WI is voluntarily recalling its "Fem-Plus" nutritional supplement for women. Because of its iron content, Fem-Plus must be sold in child-resistant packaging to comply with the Poison Prevention Packaging Act. The recalled bottles lack child-resistant packaging. A child could accidentally ingest too much iron at one time, leading to serious illness or death.
The recalled Fem-Plus were sold in white, opaque plastic bottles with blue screw-on plastic caps. Each bottle contains 60 capsules with 25 milligrams (mg) of iron per capsule. The bottle is labeled "HERBAL BIO-THERAPY *** Fem-Plus *** NO. 811 *** 60 CAPSULES." The label also reads, "MANUFACTURED EXCLUSIVELY FOR ENZYMATIC THERAPY, INC., GREEN BAY, WISCONSIN 54311."
This recall only applies to Fem-Plus packaged in containers with blue conventional screw caps. It does not include Fem-Plus packaged with white child-resistant caps labeled "push down and turn" nor any other iron-containing products manufactured by Enzymatic Therapy, Inc.
Approximately 4,435 bottles of the recalled iron product were sold to consumers through retail health food and nutrition stores nationwide between June 1, 1991 and August 2, 1993. Enzymatic Therapy has been selling Fem-Plus in child-resistant packaging since August 3, 1993. Enzymatic Therapy, Inc. has manufactured and sold this product for several years.
Neither Enzymatic Therapy, Inc. nor the Commission is aware of any poisoning incidents due to the Fem-Plus iron capsules. However, the Commission is aware of several ingestions and at least 25 deaths since 1990 from other iron- containing products, as reported by the National Association of Poison Control Centers.
Consumers should immediately return unused portions of any bottles of the recalled Fem-Plus capsules to the store where they purchased it. They will receive either a replacement bottle with child-resistant packaging or a full refund. Consumers may call Enzymatic Therapy's toll-free number 1-800-783-2286 for more information.
CPSC became aware of the packaging problem through its ongoing poison prevention packaging inspection program. CPSC enforces the requirement that any dietary supplement containing an equivalent of 250 mg or more of iron per package must have child-resistant packaging.
The U.S. Consumer Product Safety Commission 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 mission is to reduce the estimated 28.6 million injuries and 21,700 deaths associated each year with the 15,000 different types of consumer products under CPSC's jurisdiction.
The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC’s work to ensure the safety of consumer products has contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years.
Federal law bars any person from selling products subject to a publicly announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission.
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