Infant Formula Recalls

Perrigo Company is recalling 23,388 35-oz. (992-gram ) containers of Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron.

The product may be contaminated with pieces of metal

No adverse events have been reported to date.

The product was sold exclusively at Walmart stores nationwide

What to do

Customers who purchased the recalled product should look for Lot Code C26EVFV with a "use by" date of February 26, 2021, on the bottom of the package.

Use of the recalled product should be discontinued, with the product returned to any Walmart store for a refund.

Consumers with questions may contact Perrigo at (866) 629-6181.

The Food and Drug Administration (FDA) is putting the finishing touches on a rule that sets standards for manufacturers of infant formula.

In light of comments received after the interim rule published last February, the final rule provides some modifications and clarifications, and sets a date of September 8, 2014, for manufacturer compliance.

Formula standards

Under the final rule, standards include:

• Current good manufacturing practices specifically designed for infant formula -- including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter.
• A requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth.
• A requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.

“FDA sets high quality standards for the safety and nutritional quality of infant formulas during this critical time of development,” says Stephen Ostroff, M.D., FDA’s acting chief scientist.

The final rule applies only to infant formulas intended for use by healthy infants without unusual medical or dietary problems. The agency notes that many companies now manufacturing infant formula for the U.S. market have been producing safe products and have voluntarily applied many of the current good manufacturing practices and quality control procedures included in the final rule.

But this rule will set in place federally enforceable requirements for the safety and quality of infant formula.

FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the U.S. must meet federal nutrient requirements, which are not changed by the new rule. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula.

FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. FDA also inspects new facilities. If FDA determines that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

Products on the market

While breastfeeding is strongly recommended and many mothers hope to breastfeed their infants, most infants in the U.S. rely on infant formula for some portion of their nutrition. An estimated 1 million infants in the United States are fed formula from birth, and by the time they are 3 months old, about 2.7 million rely on formula for at least part of their nutrition.

Infant formula comes in three forms:

• Powder -- the least expensive of the infant formulas. It must be mixed with water before feeding.
• Liquid concentrate -- must be mixed with an equal amount of water.
• Ready-to-feed -- the most expensive form of formula that requires no mixing.

The protein source varies among different types of infant formula.

FDA’s nutrient specifications for infant formulas are set at levels to meet the nutritional needs of infants. In addition, formula manufacturers set nutrient levels that are generally above the FDA minimum requirements. Thus, babies fed infant formulas do not need additional nutrients unless they are fed a low-iron formula.

The infant formulas currently available in the United States are either “iron-fortified”—with approximately 12 milligrams of iron per liter—or “low iron”—with approximately 2 milligrams of iron per liter. The American Academy of Pediatrics (AAP) recommends that formula-fed infants receive an iron-fortified formula as a way of reducing the prevalence of iron-deficiency anemia.

Safety issues

Here are some simple steps caregivers can take to make sure their formula is safe:

• Formula preparation. In most cases, it’s safe to mix formula using ordinary cold tap water that’s boiled for one minute and cooled. Formula made with hot water needs to be cooled quickly to body temperature -- about 98 degrees Fahrenheit -- if it is to be fed to the baby immediately. If the formula is not being fed immediately, refrigerate it right away and keep refrigerated until feeding.
• Bottles and nipples. The Mayo Clinic says you may want to consider sterilizing bottles and nipples before first use. After that, you can clean them in the dishwasher or wash them by hand with soapy water.
• Water. Use the exact amount of water recommended on the label.
• Formula warming. This isn’t necessary for proper nutrition. The best way to warm a bottle of formula is by placing the bottle in a pot of water and heating it on the stove until warm (at body temperature). Never use microwave ovens for heating infant formulas. Microwaving may cause the bottle to remain cool while hot spots develop in the formula. Overheated formula can cause serious burns to the baby.
• “Use by” date. This is the date after which a package or container of infant formula should not be fed to infants. It indicates that the manufacturer guarantees the nutrient content and the general acceptability of the quality of the formula up to that date. FDA regulations require this date to be specified on each container of infant formula.
• Storage. Manufacturers must include instructions on infant formula packaging for its handling before and after the container is opened. They must also include information on the storage and disposal of prepared formula.
• Freezing formula. This is not recommended, as it may cause a separation of the product’s components.

Hospitals should stop including industry-provided samples of infant formula in new mothers’ discharge bags because the distribution is unethical and violates good public health policy, the consumer group Public Citizen argues.

It's launching a crusade against the practice, including sending letters co-signed by more than 100 other organizations to more than 2,600 hospitals across the country. 

Public Citizen also is launching an online petition calling on the three major formula makers – Abbott (maker of Similac), Mead Johnson (maker of Enfamil) and Nestle (maker of Gerber) – to stop marketing their products in healthcare facilities.

Nearly every medical authority agrees that breastfeeding for the first six months after a child is born is best for the health of both babies and mothers. But Public Citizen said research convincingly shows that mothers who received infant formula samples were less likely to breastfeed exclusively and are more likely to breastfeed for shorter durations.   

The consumer group said hospitals that distribute formula samples are in violation of a 1981 World Health Organization (WHO) code that prohibits healthcare facilities from marketing infant formula.

Two-thirds

Yet, at least two-thirds of hospitals in the U.S. distribute samples of infant formula, even if mothers have indicated that they plan to breastfeed. Succumbing to infant formula companies’ marketing techniques is costly, both in terms of money spent on formula and the health of mothers and children. Formula feeding costs between $800 and $2,800 per year.

Additionally, the formula samples usually are brand-name products, which cost up to 66 percent more than store brands. Families typically continue to use the same expensive brand they receive in samples.

“Hospitals and doctors’ offices shouldn’t be used as marketing vehicles for any product, period,” Public Citizen President Robert Weissman said. “They certainly shouldn’t be pushing products that harm the health and well-being of babies and new moms.”

Added Elizabeth Ben-Ishai, campaign coordinator for Public Citizen’s Commercial Alert project, “When hospitals distribute formula samples, they are engaging in marketing for major pharmaceutical and food companies. Many hospitals are actively trying to promote breastfeeding in their obstetrics units. But by continuing to allow marketing of infant formula in their facilities, they are undermining their own efforts.”

Federal and state health officials say they have not yet pinned down the cause of four recent Cronobacter infections but have found no evidence the cases are related.

Given the results so far, investigators say there is no need for a recall of Enfamil formula, which had been fed to some of the infected infants.  Several major retailers removed Enfamil from their shelves last month after an infant died of a Cronobacter infection in Missouri.

The four recent cases occurred in Missouri, Illinois, Oklahoma and Florida. The infants in Missouri and Florida died, while those in Illinois and Oklahoma are recovering. 

Cronobacter causes severe bacterial sepsis or meningitis in infants, which often starts with fever, and usually includes poor feeding,  crying or listlessness. It is found in the environment and in hospitals and homes. It can also multiply in powdered infant formula after the powder is mixed with water.

The Food and Drug Administrtion (FDA) said it has inspected the facilities that manufactured the infant formula and the nursery water that tested positive for Cronobacter bacteria and all were found negative.

Retailers reluctant

The findings may be encouraging to retailers, who have been reluctant to put Enfamil Premium Newborn infant formula back on their shelves, even though Mead Johnson Company says its tests have found no problems.

Walmart, Walgreens, Supervalu, Price Chopper and many smaller retailers removed the formula last month after a Missouri infant who had been fed Enfamil died. 

Mead Johnson, which manufactures Enfamil, said earlier that it had retested the batch of the formula involved in the infant's death and found no problems.

Cronobacter infections are normally very rare, with only four to six cases reported in a normal year.  There were 12 cases in 2011 and authorities say they are not certain if the higher number is the result of raised awareness or if some other factor is involved.

Cronobacter infections can be severe in young infants when they occur in the first days or weeks of life.

Breastfeeding recommended

Health officials recommend breastfeeding whenever possible.  When using powdered infant formula, CDC and FDA advise that caregivers make up fresh formula each time they feed the baby and discard any leftovers.  In addition, recommendations  for how to prepare and use powdered infant formula more safely include:

• wash your hands with soap and water before preparing the formula,
• clean all feeding equipment in hot, soapy water,
• prepare only enough formula for one feeding at a time and give it to the baby right away, and
• follow the manufacturer's directions on the printed label.

Lab results pending

In a joint release, the FDA and CDC said the following results have been confirmed from completed laboratory tests, although additional lab results are pending release:

• CDC's laboratory conducted DNA fingerprinting of the bacteria from two recent cases of Cronobacter infection in infants (Missouri and Illinois). The results show that the Cronobacter bacteria differ genetically, suggesting that they are not related. (Bacteria from cases in Oklahoma and Florida are not available for analysis.) 
• CDC laboratory tests of samples provided by the Missouri Department of Health and Senior Services foundCronobacter bacteria in an opened container of infant formula, an opened bottle of nursery water and prepared infant formula.  It is unclear how the contamination occurred.
• The FDA tested factory sealed containers of powdered infant formula and nursery water with the same lot numbers as the opened containers collected from Missouri and no Cronobacter bacteria were found.

The FDA, CDC and state agencies continue to investigate the cause of the infections using epidemiological and laboratory methods. 

Retailers are in no hurry to put Enfamil Premium Newborn infant formula back on their shelves, even though Mead Johnson Company says its tests have found no problems.

Walmart, Walgreens, Supervalu, Price Chopper and many smaller retailers removed the formula last week after a Missouri infant who had been fed Enfamil died from a rare bacterial infection attributed to Cronobacter, a microorganism that occurs in nature and is sometimes implicated in infant deaths. An Illinois baby also became ill but is recovering, officials said.

Retested

Mead Johnson says it has retested the batch of the formula involved in the infant's death and found no problems but the stores say they prefer to wait until they get the all-clear from the Food and Drug Administration (FDA).

There has been no official recall of the formula but retailers said they didn't want to take any chances.  Besides testing the formula, the FDA is examining other possible sources of the infection, including the water used to mix the formula in the infant's home.

The FDA has confirmed that it visited the plant in Zeeland, Mich., where the formula was manufactured and also examined some records at a Mead Johnson facility in Evansville, Ind.

About Cronobacter

Cronobacter is a naturally-occurring organism that, according to the Centers for Disease Control and Prevention, is implicated in a handful of infant illnesses each year.  It has a fatality rate of about 40 percent.

Although formula in sometimes implicated in infant illnesses, it is often not known whether the Cronobacter was in the formula when it was packaged or whether it was introduced later, after the package had been opened by parents and caregivers.

In 2001, a Mead Johnson product, Portagen, was recalled after an infant died in Tennessee.

CDC officials stressed the importance of parents and caregivers washing their hands thoroughly, sterilizing bottles and other equipment and preparing only small amounts of formula. 

Breast-feeding is safest

In 2008, two cases of Cronobacter infection, one in a male infant and the other in a female, were reported in New Mexico, in families living aobut 200 miles from each other. Although the infants had been fed the same brand of formula, the genetic types of Cronobacter were different.  The female suffered severe brain damage and the male infant later died of SIDS.

The exact path of transmission was not determined but traces of Cronobacter were found in vacuum cleaner samples taken from the male infant's home. No Cronobacter was found in unopened canisters of formula in either home.

The message, say health officials, is to practice extremely careful sanitation and sterilization practices when preparing and handling formula.

The safest procedure is to breast feed.  Breast-feeding not only eliminates the problem of contaminated formula but provides better nutritional and emotional support to infants.

Walmart and Supervalu have removed Enfamil from their shelves after a Missouri infant died from a rare bacterial infection attributed to Cronobacter, a microorganism that occurs in nature and is sometimes implicated in infant deaths.

The Missouri infant had been fed Mead Johnson Company's Enfamil, a popular and widely-used formula.  No recall has been issued by either the company or the Food and Drug Administration (FDA) pending further testing.

Mead Johnson said it was cooperating in the investigation but did not think its formula was to blame.

"All of our finished infant powdered products (including this batch) are tested for Cronobacter prior to shipment. If an ingredient or a batch of powdered infant formula product is found to contain Cronobacter, it is rejected and not distributed," the company said in a prepared statement.

"The batch of the product used by the child's family did not show the presence of the bacteria when it was produced and packaged, and that has recently been reconfirmed from our batch records," the company said. "This product is not being recalled - nor is any other Mead Johnson product - but some retailers are removing it from their shelves as a precautionary measure."

Premium Newborn

The product is Enfamil PREMIUM Newborn 12.5 ounce powder with number ZP1K7G on the bottom of the can. The FDA said a sample of the formula supplied by the infant's family was being tested.

The dead child was identified as Avery Cornett.  Walmart said the family had purchased the formula at its Lebanon, Mo., store. 

Mead Johnson has established a phone number for parents with questions: 1-800-BABY-123.

About Cronobacter

Cronobacter is a naturally-occurring organism that, according to the Centers for Disease Control and Prevention, is implicated in a handful of infant illnesses each year.  It has a fatality rate of about 40 percent.

Although formula in sometimes implicated in infant illnesses, it is often not known whether the Cronobacter was in the formula when it was packaged or whether it was introduced later, after the package had been opened by parents and caregivers.

In 2001, a Mead Johnson product, Portagen, was recalled after an infant died in Tennessee.

CDC officials stressed the importance of parents and caregivers washing their hands thoroughly, sterilizing bottles and other equipment and preparing only small amounts of formula. 

Breast-feeding is safest

In 2008, two cases of Cronobacter infection, one in a male infant and the other in a female, were reported in New Mexico, in families living aobut 200 miles from each other. Although the infants had been fed the same brand of formula, the genetic types of Cronobacter were different.  The female suffered severe brain damage and the male infant later died of SIDS.

The exact path of transmission was not determined but traces of Cronobacter were found in vacuum cleaner samples taken from the male infant's home. No Cronobacter was found in unopened canisters of formula in either home.

The message, say health officials, is to practice extremely careful sanitation and sterilization practices when preparing and handling formula.

The safest procedure is to breast feed.  Breast-feeding not only eliminates the problem of contaminated formula but provides better nutritional and emotional support to infants.

No illnesses have been reported to date. However, in the rare instance that an infant were to inhale the infant formula into the lungs, the presence of these particles could present a serious risk to the infant's respiratory system and throat.

Any injuries associated with this problem would be likely to show up within three to four hours. The symptoms could be varied depending on whether there is damage to the throat or lungs.

Damage to the throat or lungs may include coughing, difficulty swallowing or difficulty breathing.

If you may have fed this lot of GENTLEASE to your baby, and you have any concerns about your baby's health, you should contact your baby's physician immediately.

There were approximately 41,464 24-ounce cans of this lot of recalled product distributed, beginning on December 16, 2005, through many major retail stores across the country, so the consumer should concentrate on the code on the can rather than on the place of purchase.

The affected products can be identified by the lot number and expiration/use by date embossed on the bottom of the can of BMJ19, use by 1 Jul 07.

Mead Johnson and the Food and Drug Administration are currently investigating how the metal particles got into the infant formula.