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“Fem-Plus" nutritional supplements

CPSC Recall #94-038 — February 16, 1994

Recall Summary

Recall Number94-038
Recall DateFebruary 16, 1994
Remedy TypeRefund, Replace
Units AffectedApproximately 4,435

Product

“Fem-Plus" nutritional supplements

Description

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.

Hazard

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.

Incidents & Injuries

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.

Remedy Instructions

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.

What Should You Do?

Stop using this product immediately. Contact the manufacturer for a Refund, Replace at no charge. If you experienced an injury, report it at SaferProducts.gov.

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Frequently Asked Questions

Follow the consumer action instructions in the recall notice above. Most recalls require you to stop using the product and contact the manufacturer directly — either by calling the toll-free number listed in the official CPSC notice or by visiting the manufacturer's website. You generally do not need a receipt or original packaging to claim a remedy. The manufacturer is legally required to provide the remedy (Refund, Replace) at no cost to you.

Yes. If you were injured by a defective consumer product — whether recalled or not — you may have grounds for a product liability claim against the manufacturer and potentially the retailer. A recall notice can serve as evidence that the manufacturer was aware of the defect. Injuries that may support a claim include burns, lacerations, fractures, electric shock, choking incidents, and chemical exposure. Most product liability attorneys work on a contingency fee basis, meaning you pay nothing unless you win. Consult an attorney promptly, as statutes of limitation vary by state.

In most cases, no. CPSC-coordinated recall remedies are designed to be accessible without proof of purchase. Manufacturers typically ask consumers to self-certify ownership and may ask for photos of the product or its serial number. Some manufacturers request that you mail in a portion of the product (such as a cut cord or removed component) as proof of disposal. Check the specific remedy instructions for this recall for exact requirements. If you registered your product at the time of purchase, the process is usually even simpler.

If the original manufacturer has gone out of business, the recall remedy may no longer be available through them. In this case, contact CPSC directly at 1-800-638-2772 or cpsc.gov for guidance. If the brand was acquired by another company, the acquiring company may have assumed recall obligations. In some cases where a remedy is unavailable, CPSC advises consumers to safely dispose of the product. If you were injured by the product of a defunct company, consult a product liability attorney — parent companies, distributors, and retailers may still bear liability in some circumstances.

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