Abbott Voluntarily Recalls Certain Similac® Brand Powder Infant Formulas That Did Not Meet Its Quality Standards

CP_Recalls — Wed, 22 Sep 2010 19:07:01 +0000

Abbott Voluntarily Recalls Certain Similac® Brand Powder Infant Formulas

Abbott is initiating a proactive, voluntary recall of certain Similac-brand, powder infant formulas in the U.S., Puerto Rico, Guam and some countries in the Caribbean.

Abbott is recalling these products following an internal quality review, which detected the remote possibility of the presence of a small common beetle in the product produced in one production area in a single manufacturing facility. The United States Food and Drug Administration (FDA) has determined that while the formula containing these beetles poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae, could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract. If these symptoms persist for more than a few days, a physician should be consulted.

The recall of these powder infant formulas includes:

Certain Similac powder product lines offered in plastic containers.
Certain Similac powder product lines offered in sizes such as 8-ounce, 12.4-ounce and 12.9-ounce cans.

To immediately find out if the product in your possession is included in this recall, parents and caregivers should visit www.similac.com/recall, and type in their lot number to determine if their product is affected, or call (800) 986-8850.

No Abbott liquid infant formulas are impacted. Products not involved in the recall include all Abbott Nutrition liquid ready-to-feed and concentrated infant formulas and all powder and liquid specialty formulas, such as Similac Expert Care™ Alimentum®, Elecare®, Similac Expert Care™ Neosure®, Similac® Human Milk Fortifier, and metabolic formulas for inherited disorders.

About the Recall

The company is implementing a plan to address this matter in the affected manufacturing facility, which is expected to be completed shortly. No other facilities or products are involved in this recall.
Abbott has consulted with the U.S. FDA regarding this recall.

Information for Parents and Caregivers

Products with affected lot numbers should be returned to Abbott at no cost to the consumer.
Parents and caregivers can go to www.similac.com/recall or call Abbott’s consumer hotline, (800) 986-8850, 24 hours a day, seven days a week.
Both the website and the consumer hotline have specific details on how to complete the return process.

Holger Liepmann, executive vice president, Abbott Nutrition said:

“Abbott understands that parents expect to feed their children only the highest quality product. We are taking this action so that parents know that the infant formula products they provide unquestionably meet the highest quality standards for which they are known. We regret any inconvenience this situation poses to parents and consumers.”

: Abbott Voluntarily Recalls Certain Similac® Brand Powder Infant Formulas That Did Not Meet Its Quality Standards

Nationwide Voluntary Product Recall of Neocate® Infant Specialized Formula Lot P91877

CP_Recalls — Mon, 28 Sep 2009 08:27:57 +0000

Neocate Infant Formula

Nutricia North America, Inc. (“Nutricia”) has contacted customers to undertake the voluntary recall and replacement of one (1) lot of the specialized infant formula product, Neocate®. This recall involves a limited quantity of individual cans (approximately 3700) from Lot # P91877, and does not affect any other Neocate® products or lot numbers.

Neocate® is a hypoallergenic dry powder formula packaged in 14 oz. cans distributed to pharmacies, health care professionals and consumers nationwide. Neocate® is not intended for general use and is usually given to infants in the care of health care professionals. The affected cans were distributed in commerce between September 1, 2009 and September 11, 2009.

Nutricia has been informed by the manufacturer of Neocate® that, due to a one-time blending error, a limited quantity of the individual cans of Neocate® Infant (original formula) contain protein levels lower than that declared on the label.

This limited formulation concern does not present any immediate risks of injury or other adverse health consequences. No adverse events have been reported as a result of this issue. The affected product from Lot # P91877 has a reduced protein level equivalent to 1.75g protein/100kcal – a shortfall of approximately 0.05g protein/100kcal based on the U.S. infant formula minimum requirement of 1.8g protein/100kcal. However, the affected product from Lot # P91877 continues to meet the minimum guidelines for protein established by the World Health Organization.

Although short-term consumption of product from the affected batch is very unlikely to cause immediate nutritional issues, longer term consumption might influence the healthy growth curve in certain infants.

Because the quality and safety of Nutricia’s products and the well-being of its customers are the company’s primary concerns, the voluntary recall has been initiated. The Food and Drug Administration has been apprised of this recall. The company apologizes for any inconvenience to our customers and consumers.

Recommended Action to be Taken by the User

The affected products have the Lot # P91877; this number can be found at the bottom of each can and on the right hand side of the case label.

Parents, caregivers, and health care professionals who have questions or concerns related to the consumption of the affected product are advised to contact the Nutricia North America Customer Helpline at 1-800-365-7354, option 8-6061. We can be reached during normal business hours Monday through Friday from 8:30am EDT to 5:00pm EDT.and for special extended hours 8:30 am EDT to 8:00 pm EDT on Monday and Tuesday, September 28 and 29th.

Working with Nutricia, the manufacturer of Neocate® has implemented appropriate corrective and preventative actions, to ensure that this blending error in the manufacture of the product is not repeated. Nutricia will continue to carefully monitor the situation and follow-up with its customers to ensure prompt replacement of the affected product.

For more information please visit www.nutricia-na.com or www.neocate.com.

For further information regarding this release, please contact Meredith Klein, Edelman PR at (312) 233-1236.

Children's Product Recalls » baby formula

Abbott Voluntarily Recalls Certain Similac® Brand Powder Infant Formulas That Did Not Meet Its Quality Standards

Nationwide Voluntary Product Recall of Neocate® Infant Specialized Formula Lot P91877

Recommended Action to be Taken by the User