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Subject:
From:
Phyllis Adamson <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Wed, 12 Jan 2005 07:32:48 -0700
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Was the FDA posting date of this announcement given? The letter from B-M-S
was Dec 9,'03, well before the "use by" date. Was this letter to the FDA?
If so, why did the FDA wait until months after the "use by" date to
publicly post the notice on their site? If any hospital had them, any
remaining product would have long since been thrown out. No residue to be
tested in case of baby illness or retroactive investigation.

We had some RTF in our hospital that had an ugly greyish residue on the
bottom of the bottles. We complained to the sales rep. She said it was
normal separation and all bottles should be shaken up very well (hard)
before use to blend all the ingredients. I think that stopped the refunds
from the babies. Of course, no one wanted to make an FDA report because
these preemie babies were only spitting it up, not getting sick.

Phyllis
 

> was on the FDA website this morning:

>  

> PRODUCT

> Mead Johnson Nutritionals brand Enfamil LactoFree with LIPIL milk-based 

> infant formula, lactose-free, iron fortified, concentrated liquid in a 13
fl. oz. 

> can. Sold in cases of 12 cans each; case UPC  3-0087-0614-01. Recall # 

> F-132-5.

> CODE

> USE BY 1 AUG 04/ LACLIP/  AGA29.

> RECALLING FIRM/MANUFACTURER

> Bristol Myers Squibb Company, Evansville, IN, by letter dated December 9, 

> 2003. Firm initiated recall is complete.

> REASON

> May have an off-odor, clumping and product separation.

> VOLUME OF PRODUCT IN COMMERCE

> 6408 cases.

> DISTRIBUTION

> Nationwide.

>  

> I have added it to the list I keep of formula recalls since 1982. These
are  

> recalls, the only ones reported to the FDA and made public. Market
withdrawals 

> of faulty formula are done without public knowledge.

>  

> Marsha Walker, RN, IBCLC

> Weston, MA

> 

>              ***********************************************

 


--- Phyllis Adamson, IBCLC, RLC
--- Glendale, AZ, USA
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