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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.
Approximately 140,000
Recall Details
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.
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.
Note: Individual Commissioners may have statements related to this topic. Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.
Related Recalls
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The recalled dietary supplements contain iron which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
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The cord on the hair stylers can detach if the unit is dropped, posing an electrocution or shock hazard to users.
The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risk of injury or death associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product-related 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 injuries associated with consumer products over the past 50 years.
Federal law prohibits any person from selling products subject to a Commission ordered recall or a voluntary recall undertaken in consultation with the CPSC.
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