March 11, 2015
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/recall9, 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/recall10 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.
SOURCE: U.S. Food and Drug Administration
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