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Robert Kurkiewicz Sr. Vice President, Regulatory Affairs (800) 8184555 4105 Robert. Kurkiewicz sunpharma.com URGENT: DRUG RECALL Hydrochloride ExtendedRelease Tablets USP (SR), 200 mg July 17, 2015,
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How to fill out attachment 3 - recall?
01
Gather all necessary information: Before filling out attachment 3 - recall, ensure that you have all the required details related to the recall. This may include the date of the recall, the product or service being recalled, and any other relevant information.
02
Identify the reason for the recall: Determine the specific reason why the recall is being initiated. This could be due to safety concerns, product defects, or other regulatory requirements. It is important to clearly state the reason in attachment 3 - recall.
03
Provide a detailed description: In attachment 3 - recall, provide a comprehensive description of the recalled product or service. Include specific details such as the brand name, model number, batch or lot numbers, and any distinguishing features. This information will help consumers or recipients identify if they have the recalled item.
04
Specify the potential risks: Clearly outline the potential risks or hazards associated with the recalled product or service in attachment 3 - recall. Highlight any dangers to consumer health, safety, or well-being, and provide instructions on what actions should be taken in response to the recall.
05
Include contact information: Make sure to include the contact information for the responsible party or organization initiating the recall in attachment 3 - recall. This should include a phone number, email address, and mailing address, where consumers or recipients can reach out for further assistance or information.
Who needs attachment 3 - recall?
01
Manufacturers: Attachment 3 - recall is particularly important for manufacturers who need to initiate a product recall. It allows them to provide relevant details about the recall, such as the reasons, potential risks, and instructions for affected parties.
02
Distributors: Distributors who have received the recalled product and are responsible for its distribution should also be aware of attachment 3 - recall. It helps them understand the product or service being recalled and enables them to take appropriate actions to notify and assist their customers.
03
Retailers: Retailers who have sold the recalled product need attachment 3 - recall to inform them about the recall details. This allows them to take the necessary steps, such as removing the product from shelves or contacting customers who have made purchases.
04
Consumer Protection Agencies: Government agencies responsible for consumer protection may require attachment 3 - recall in order to document and oversee product recalls. This information helps them investigate and address potential risks to the public.
05
Consumers or Recipients: Attachment 3 - recall is essential for consumers or recipients of the recalled product or service. It provides them with the necessary information to identify if they possess the recalled item, understand the associated risks, and take appropriate actions recommended in the recall notice.
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What is attachment 3 - recall?
Attachment 3 - recall is a form used to report product recalls to the appropriate regulatory body.
Who is required to file attachment 3 - recall?
Manufacturers and distributors are required to file attachment 3 - recall.
How to fill out attachment 3 - recall?
Attachment 3 - recall must be filled out with detailed information about the recalled product, including the reason for the recall and the steps being taken to address the issue.
What is the purpose of attachment 3 - recall?
The purpose of attachment 3 - recall is to ensure that recalled products are properly documented and reported in accordance with regulatory requirements.
What information must be reported on attachment 3 - recall?
Information such as the product name, lot number, reason for recall, number of units affected, and corrective actions being taken must be reported on attachment 3 - recall.
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