Due to complaints of foul odor and gastrointestinal problems, Gerber Products Co has voluntarily recalled some of its Good Start Gentle powdered infant formula, both the company and the federal regular announced on March 9.
Geber said it’s offering a replacement for the recalled formula — a 23.2 ounce plastic package from batch GXP1684.
In its website, the United States Food and Drug Administration clarified that the recall is limited to batch GPX1684, expiring on March 5, 2013.
The FDA recommends that consumers who have purchased the Good Start Gentle formula with that batch code and expiration date should call 1-800-487-7763 (Gerber Parents Resource Center), and a replacement will be offered.
The product poses no health or safety risk but might have an off-odor noticeable to some consumers, Gerber clarified. “In some cases spit-up and other gastrointestinal complaints have been reported,” it said. The agency appeared to back Gerber’s claims, saying only there have been reports of bad odors.
The Florham Park, New Jersey, company says it’s coordinating closely with retail outlets to get any remaining products off the shelves.
Consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at 1-800-332-1088 or online www.fda.gov/MedWatch/report.htm.
Gerber corners only a fraction of the infant formula market in the U.S., which is dominated by three big firms — Abbott Laboratories, Nestle and Mead Johnson. Altogether, the three companies manufacture more than 90 percent of all infant formula produced in the United States.
The popular baby food company wasn’t mixed up in the major infant formula scare that rocked American consumers a year after the 2008 Chinese milk scandal, which involved milk and infant formula adulterated with melamine.
2009 infant formula scare
Problems with melamine-spiked formula surfaced in the fall of 2008 in China, where unscrupulous makers purposely dumped the chemical into watered-down milk to inflate protein levels. In what turned out to be one of the worst food safety incidents in the recent years, about 300,000 people were affected, six infants died from kidney stones and other kidney damage, and another 860 babies were hospitalized.
Americans also got a scare when the FDA released confused information about a number of infant formulas that had been tainted with melamine. But concentrations in China were as much as 2,500 parts per million — about 10,000 times greater than what the FDA found in the U.S. formula.
Melamine, used as a solution to clean manufacturing equipment and in product packaging, can bind with other chemicals in urine. This can cause stones in the kidney or bladder, and in extreme cases, kidney failure.
In contrast to what had happened in China, U.S.-made formula had been accidentally contaminated with melamine during the manufacturing process, the FDA said.