Recalls: Tablet or Capsule Drugs
December 17, 1992 Release # 93-02 PRODUCT: "Vita-Worth" brand iron tablets, by General Nutrition Corporation. The tablets are packaged in a white plastic bottle with a screw-on cap. There are 100 tablets per bottle. PROBLEM: Lack of child-resistant closure means that a child could accidentally swallow the iron tablets. Just eight or ten tablets, if consumed by a child at one time, can cause serious illness or death. WHAT TO DO: Immediately return the "Vita-Worth" recalled iron tablets to the store where purchased for a refund. WASHINGTON, DC --- CPSC, General Nutrition Corporation of Pittsburgh, PA is voluntarily recalling its 100 tablet size bottles of "Vita-Worth" brand iron tablets. The Vita-Worth iron tablets were sold without child-resistant closures as required by the Poison Prevention Packaging Act. The lack of child-resistant closure means that a child could accidently swallow the iron tablets. Just eight or ten tablets, if consumed by a child at one time, can cause serious illness or death. The tablets are packaged in a white plastic bottle with a screw-on cap. There are 100 tablets per bottle. The bottles' paper labels read, in part, "Vita-Worth *** Iron, 37.5 *** 100 Tablets *** Distributed by General Nutrition Corporation, Pittsburgh, PA 15222, USA." The recall does not include the 60 tablet bottles, which have child-resistant packaging. Approximately 22,000 bottles of the iron tablets were sold to consumers through the firm's 1,000 company-owned and 250 franchisee-owned retail stores nationwide. The pills were sold between July 1, 1992 and October 31, 1992. Consumers should immediately return the recalled iron tablets to the store where purchased for a refund. Neither the recalling firm nor the Commission is aware of any poisoning incidents due to the Vita-Worth brand iron tablets. However, the Commission is aware of several ingestions and at least 11 deaths in 1991 from iron containing products, as reported by the American Association of Poison Control Centers. CPSC became aware of the packaging problem as a result of its ongoing poison prevention packaging inspection program. 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 CPSC enforces the requirement that any dietary supplement containing an equivalent of 250 mg or more of iron per package must be supplied with child-resistant packaging. The Commission's mission 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 Read more.
December 12, 1978 Release # 78-104 Armour Replaces Safety Caps On Thyroid Tablets WASHINGTON, D.C. (Dec. 12) -- Armour Pharmaceutical Company and the U.S. Consumer Product Safety Commission (CPSC) today announced that Armour will replace the child-resistant caps on approximately 140,000 100-tablet bottles of prescription thyroid tablets. Efficacy and safety of the tablets themselves are not in question and no recall is involved. The firm voluntarily initiated the cap replacement program, which involves only those packages held in its warehouses, after Commission testing indicated that some adults might be unable to properly reclose the safety feature of the present package during use in the home. Regulations under the Poison Prevention Packaging Act currently require that at least 90% of those adults tested be able, not only to open the packages, but also to properly close them to protect young children from accidentally swallowing the contents. In addition to replacing caps on current inventory, Armour plans to continue its on-going safety packaging program to meet its own standards of quality and to assure compliance with CPSC regulations. In presenting this matter to the Commission, the staff acknowledged that upon receipt of the results of Commission testing, Armour promptly stopped distribution of the product in question and took immediate action to investigate and correct the problem Read more.
Product Substitution For Excedrin Announced NEWS from CPSC U.S. Consumer Product Safety Commission Office of Information and Public Affairs Washington, DC 20207 FOR IMMEDIATE RELEASE June 7, 1977 Release # 77-059 Product Substitution For Excedrin Announced WASHINGTON, D.C. (June 7) -- Bristol Myers Products, a division of Bristol Myers Company, and the Consumer Product Safety Commission (CPSC) announced today a product substitution of the company's 225 tablet package size and 375 tablet size of Excedrin analgesic tablets which were distributed nationwide prior to April 1977. CPSC testing found same packages for this product failed to comply with Federal regulations requiring that the packages be child-resistant. The product substitution covers warehouse inventories of those major wholesale and retail customers handling approximately 81% of the merchandise. Existing inventories of these packages are being retrieved and replaced by upgraded packages which were tested by Bristol Myers to assure CPSC compliance. The product substitution will involve approximately 150,000 packages and will be completed by the middle of June. These two sizes represent less than 3% of Excedrin analgesic annual unit sales volume. Bristol Myers Products, in addition, has improved its packages for these sizes of Excedrin analgesic products and has expanded its quality control program to reduce the likelihood of similar situations arising in the future. This program is not a substitute for any legal action which may be deemed necessary by CPSC. Read more.
