Human Drug Model Press Release
(Insert Information where bolded text appears)
Company Name Issues Voluntary Worldwide/Nationwide Recall of Product Due to
Reason for Recall
FOR IMMEDIATE RELEASE – Date – City, State, Company Name is voluntarily recalling quantity lots of product name, description of dosage form to the hospital, retail or consumer level. The products have been found to describe reason for recall/problem.
Risk Statement: The product has/potentially could result in describe public health risk. [Note: risks associated with the use of recalled product should include information about groups that would most likely be affected]. Company has received reports of state adverse events or injuries, number, type, and status have been received/Company has not received any reports of adverse events related to this recall.
The product is used as a state indication(s) and is packaged in state type of packaging, number of units, and any associated codes. The affected product name lots include the following lot numbers and expiration dates [this information may also be included in table format within the body of the press release for recalls involving a large number of products or lot numbers]. The product can be identified by provide additional details about how product can be identified by users. Product was distributed Worldwide/Nationwide to describe type of outlets (wholesale/retail/via internet).
Company is notifying its distributors and customers by describe method and is arranging for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.
Consumers with questions regarding this recall can contact Company by phone number or e-mail address on days of the week from beginning and ending time, specifying time zone. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.