Below is an excerpt of the Medical Device Recall Notification Letter and Response form template. For correct formatting, Download the formatted Word Doc FDA Medical Device Model Recall Notification Letter and Response form template to freely edit. Company Name Date (Month, Day, Year) URGENT:¹ MEDICAL DEVICE RECALL² PRODUCT NAME (1) Attention to Customer: [...]
MODEL DRUG RECALL LETTER EXAMPLE John Doe Laboratories Somewhere, U.S.A. 12345 Control Division Date _______________ (red print) --URGENT: DRUG RECALL -- Nonsterile injectable Re: List 1234, Cyanocobalamin Injection Lot No. 4321 Recent tests showed that the above lot number of this product is not sterile and therefore, represents a potential public health hazard. [...]
Published by the FDA under Industry Guidance for Recalls Note: Text in bold should be modified to reflect appropriate company information Company Name Issues Nationwide Recall of Product(s) Name(s) FOR IMMEDIATE RELEASE: Date of News Release Company Address Telephone/Company Website On date of recall initiation, Company Name initiated a nationwide recall of quantity and name of product(s). The product(s) have been [...]