FindLaw Class Action and Mass Tort Center: Recalls: Food, Drugs and Medical Devices: Portagen Powder Recall
NEWS: U.S. Department of Health and Human Services
FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Portagen Powder Recall
NEWS RELEASE
Contact: Mead Johnson Nutritionals
1-888-587-7275
For Immediate Release
Portagen Powder Recall
Evansville, IN - March 29, 2002 - Mead Johnson Nutritionals, in keeping with
our commitment to provide safe and healthy nutritional products, is recalling
one batch of Portagen powder, a nutritional product for adults, toddlers and
infants with rare digestive diseases that prevent them from digesting or absorbing
fats. Portagen is intended for use under a physician's supervision and is not
typically available at retail stores. The batch, coded BMC17, with an expiration
date of January 2003, is in national distribution and first shipped to distributors
and hospitals in February 2001. Any cans from t his shipment should not be used.
No other batches of Portagen product are involved.
The recall is being initiated after a report that a premature infant died in
April 2001 of a rare form of meningitis caused by the bacteria Enterobacter
sakazakii. The child reportedly became ill after being tube-fed Portagen
from this batch.
Mead Johnson wants to assure consumers that all of our products are manufactured
with strict adherence to the highest standards, using high quality ingredients.
The microbiological quality of each batch of Portagen is assessed using validated
methods, and our product specifications are consistent with those proposed by
the FDA and other U.S. regulatory organizations.
Consumers who may have Portagen from this batch code can return the product
to the place of purchase. Consumers with questions about Portagen or the recall
can contact 1-888-587-7275.
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