I just got this from my son who's an environmental safety specialist at UTexas Medical Center:

ENTEROBACTER SAKAZAKII, INFANT FORMULA - IRELAND: RECALL
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A ProMED-mail post <http://www.promedmail.org>
ProMED-mail is a program of the 
International Society for Infectious Diseases <http://www.isid.org>

Date: Fri 21 Jan 2005
From: ProMED-mail <[log in to unmask]>
Source: Food Safety Authority of Ireland [edited]
<http://www.fsai.ie/news/press/pr_05/pr20050120.asp>


Infant formula product recalled

The Food Safety Authority of Ireland (FSAI) today [Fri 21 Jan 2005] advised hospitals and pharmacies that may still have stocks of the infant formula Pregestimil to immediately remove it from use. Pregestimil is a specialist milk formula for premature infants. At the end of 1Dec 2004, a number of batches were associated with serious illness, which triggered a global voluntary product recall of all batches of Pregestimil by manufacturers Mead Johnson Nutritionals.

Although the implicated batches were not distributed in Ireland, it has come to the attention of the FSAI that limited quantities of the formula could be still available in some hospitals and/or pharmacies. The company has confirmed to the FSAI that the implicated batches of the formula were only distributed to Algeria and France. However, as a precautionary measure, the FSAI is asking all hospitals and pharmacies not to use the product and to remove it from use. 

The global recall was initiated by the manufacturers after batches of the product were associated with 2 infant deaths in France. The deaths were due to _Enterobacter sakazakii_, a pathogen that can cause serious infection in vulnerable infants, but poses little risk to healthy, full-term infants.

To ensure that all product has been fully recalled, the FSAI is enlisting assistance from environmental health officers, the
National Disease Surveillance Centre and the Irish Medicines Board to alert chemist shops, pharmaceutical wholesalers and the medical profession.

Dr. John O'Brien, Chief Executive, FSAI stated that this recall is a precautionary measure and that parents of premature babies should not be unduly alarmed. Those who have concerns should contact their medical practitioner for advice.

"This product is very specialized and is adapted for premature babies with intolerance to cow's milk protein. As such, it was
only available in hospitals and a limited number of pharmacies; it was not available in shops or supermarkets. The company has assured us that the implicated batches were never distributed on the Irish market. However, for maximum safety, all batches of the Pregestimil are being recalled worldwide. I would advise any parent who may have a can of Pregestimil in their home not use it and to return it to its point of supply, be it the hospital or their pharmacy."

ProMED-mail
<[log in to unmask]>

[_Enterobacter sakazakii_, until 1980, had been referred to as a "yellow pigmented" _E. cloacae_. The bacterium has been
associated with a number of outbreaks of infection, usually meningitis, in premature neonates (1), with high rates of morbidity and mortality, although infection can occur in infants, children and adults (2).

The association of neonatal infection with the use of powdered infant formula is not new (i.e., reference 3 from 1983). The organism has been associated with a number of different kinds of powdered formulas from many different countries, including the USA (4).
Microbiological typing has shown that patient and formula isolates shared the same typing pattern (5). The organism appears to be more resistant to osmotic and dry stress than other _Enterbacteriaceae_ (6) and may be more thermotolerant as well. It 
was reported in 2004 to be isolated in powdered formula production environments, other food factories (pasta, potato flour, cereal) as well as in households (7). Since these products are not truly sterile, guidelines (8) have been set forth to minimize the risk.

1. Farber JM: _Enterobacter sakazakii_ - new foods for thought? Lancet 2004;363:5-6.

2. Lai KK: _Enterobacter sakazakii_ infections among neonates, infants, children, and adults. Medicine 2001;80:113-22.

3. Muytjens HL, Zanen HC, Sonderkamp LA, et al: Analysis of eight cases of neonatal meningitis and sepsis due to _Enterobacter
sakazakii_. J Clin Microbiol 1983;18:115-20.

4. Centers for Disease Control and Prevention. _Enterobacter sakazakii_ infections associated with the use of powdered infant
formula - Tennessee, 2001. MMWR 2002;51:297-300.

5. Clark NC, Hill BC, O'Hara CM, et al: Epidemiologic typing of _Enterobacter sakazakii_ in two neonatal nosocomial outbreaks. Diagn Microbiol Infect Dis 1990;13:467-72.

6. Breeuwer P, Lardeau, Peterz M, Joosten HM: Desiccation and heat tolerance of _Enterobacter sakazakii_. J Appl Microbiol 2003;95:967-73.

7. Kandhai MC, Reij MW, Gorris GM, et al. Occurrence of _Enterobacter sakazakii_ in food production environments and
households. Lancet 2004;363:39-40.

8. Agostoni AC, Axelsson I, Goulet O, et al: Preparation and handling of powdered infant formula: a commentary by the ESPGHAN
committee on nutrition. J Pediatr Gastroenterol Nutr 2004;39:320-22. - Mod.LL]

[see also: 1997 - ----Meningitis, E. sakazakii - Scotland (Kilmarnock) 19970314.0567] .......................as/ll/msp/dk

Marilyn Farland, IBCLC
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