(301) 504-0580 Ext. 1193
|Release # 94-038
Enzymatic Therapy Inc. Recalls Iron
Product Without Child-Resistant Packaging
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
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 --- In cooperation with the U.S. Consumer Product Safety Commission (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
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 protects the public from the unreasonable risk of injury or death from 15,000
types of consumer products under the agency's jurisdiction. To report a dangerous product
or a product-related injury and for information on CPSC's fax-on-demand service, call
CPSC's hotline at (800) 638-2772 or CPSC's teletypewriter at (800) 638-8270. To order a
press release through fax-on-demand, call (301) 504-0051 from the handset of your fax
machine and enter the release number. Consumers can report product hazards to firstname.lastname@example.org.