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. Consequently, we are recalling this lot from the market. Other lot numbers are not involved.
Please examine your stocks immediately to determine if you have any of Lot 4321 on hand. If so, discontinue dispensing the lot and promptly return via parcel post, to our New York City Plant; ATTENTION RETURNED GOODS.
NOTE: If a sub-recall is indicated in a particular situation, the following paragraph should be added:
“If you have distributed any of lot 4321, please immediately contact your accounts, advise them of the recall situation, and have them return their outstanding recalled stocks to you. Return these stocks as indicated above.”
You will be reimbursed by check or credit memo for the returned goods and postage.
Please return the enclosed card immediately providing the requested information.
This recall is being made with the knowledge of the Food and Drug Administration. The FDA has classified this recall as class __________ (if classified).
We appreciate your assistance.
John Doe
President