FDA recall record

Mead Johnson Nutrition Pregestimil ready to use 20 calorie, 2 oz bottle recall — FDA F-2170-2015

Some Pregestimil 20 Calorie Nursette Bottles from batch EV5A6F were inadvertently packaged in Pregestimil 24 Calorie Nursette cartons. The individual…

Class IIclassification
F-2170-2015official record ID
May 13, 2015report date

Recall record at a glance

Official recordF-2170-2015
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmMead Johnson Nutrition
Report dateMay 13, 2015
Recall initiation dateMar 26, 2015
Quantity235 cases
LocationEvansville, IN, United States

Official product description

Pregestimil ready to use 20 calorie, 2 oz bottle; 6 bottles per carton; 8 cartons per case

Why the product was recalled

Some Pregestimil 20 Calorie Nursette Bottles from batch EV5A6F were inadvertently packaged in Pregestimil 24 Calorie Nursette cartons. The individual Nursette bottles are correctly labeled as 20 Calorie. The carton is the cardboard sleeve wrapped around 6 bottles, the bottle labels and the outer corrugated case all correctly state 20 calorie.

Distribution information

Domestic: AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MA, MD, MI, MS, NC, NE, NH, OH, OK, PA, SD, TX, UT, VA, WI, WV, Foreign: None

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Visit.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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