Health directors received this via email. How much more confusing can this be?
Barb Whitehead, IBCLC
Eastern NC


RE:  ENFAMIL NUTRAMIGEN "RECALL"
> **************************************************
> **************************************************
>
> FDA is providing this update to ask our State and local
> counterparts for their assistance and to keep FDA informed of
> the current status of the Nutramigen recall by the Mead Johnson
> Company.
>
> We are NOT asking you to undertake an emergency response.  However,
> state and local agencies who inspect retail drug, food or mass
> merchandiser stores may be able to provide FDA with significant
> assistance during such inspections by assuring that the proper
> Spanish instructions for the Nutramigen recall are available at the
> retail stores where the product is sold and by helping resolve any
> confusion at retailers concerning the status of Nutramigen.
>
> Please note that our previous message to you referenced placards to
> be placed at the point of sale in retail stores.  This has changed.
> It was decided that it would be more helpful to the consumer if a
> tearpad was placed on the shelves rather than a placard, so that the
> caregiver could take the correct Spanish instructions for use at home.
> The tearpads were sent by Mead Johnson to retail stores via an
> express delivery service and were to have arrived at all retail
> stores between July 14, 2001 and July 16, 2001.
>
> Language barriers continues to present a problem with this action.
> The cover letter written in English, which was sent with the
> tearpads contains specific instructions for the placement of the
> tearpads.  A Spanish version is not available.  The instructions
> for use of the product on the tearpads are written only in Spanish.
> The Spanish instructions for use on the Nutramigen can labels are
> on the reverse side of the label and can only be seen or read after
> the label has been removed from the can.  As a result of this, FDA
> has observed the following:
>
>       1)        Some retail stores are not displaying the tearpads
> because the Nutramigen label on the outside of the product is in
> English with appropriate instructions for use and the retail store
> personnel do not realize that Spanish labeling is on the inside,
> therefore they see no use for the Spanish language tearpads.
>
>       2)        Spanish speaking personnel in retail stores with
> large hispanic customer populations may not read, or be able to
> read, the English cover letter instructing them to place the
> tearpads at the location of the Nutramigen.
>
> In addition, FDA has observed the following:
>
>       1)        Some tearpads are being placed on the pharmacy counter
> instead of being placed near the affected Nutramigen products.
>
>       2)        Some stores have the ready to use and the powdered
> formulas in significantly separated areas of their stores, but
> have placed tearpads at only one of the products.
>
>       3)        Some stores claim not to have received tearpads.
>
> FDA has become aware of at least one company (Unity Wholesale
> Grocery, Lexington, KY) that purchases these Nutramigen products
> from retail stores at discounted prices, recases them, and ships
> them to stores who are not Mead Johnson customers.  We are working
> with this company to make sure appropriate action is taken by their
> customers, but Mead Johnson will NOT send tearpads or other notices
> to these customers, since they have no knowledge of who they might
> be.  Since FDA knows of one company with this practice, there may
> others that FDA is not aware of.  Thus, tearpads may not be in place
> at some retail stores because the products have been diverted.  Thus,
> if tearpads are not present, it will be important to determine
> whether the product was received from Mead Johnson, or from some
> other source.
>
> Mead Johnson has sent out brokers to place sticker labels bearing
> correct instructions for use [in both English and Spanish] on
> in-store stocks and to assure that tearpads are in place.  New
> labels have been applied in approximately 5,000 stores to date,
> and will continue until all 35,000 stores have been re-labeled
> with the correct labeled instructions .  Mead Johnson has been
> informed that the brokers will be able to visit approximately
> 10,000 stores per week.  Warehouse stocks is being sent back to
> Mead Johnson for relabeling.  This effort, therefore, may result
> in a shortage of product over the next several weeks.  Mead Johnson
> is restocking their supply chains as fast as possible and is making
> emergency shipments to persons unable to find Nutramigen locally.
> Consumers who cannot find Nutramigen should be referred to Mead
> Johnson at 1-800-BABY123 from 8 AM to 4:30 PM Monday through
> Saturday, Central Time.  This number may also be used for any
> adverse events, complaints, injury or illness reports.
>
> Mead Johnson has also provided a toll-free number for stores needing
> additional supplies of tearpads.  Mead Johnson can be reached at
> 1-800-718-7725.
>
> A copy of the letter to retailers and a copy of the tearpad
> information may be obtained from the Division of Federal-State
> Relations by calling (301) 827-6906. We are sending a separate
> Message by email to food and food service program directors which
> will have these two documents as attachments.
>

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