MODERATE RISK Terminated F-2170-2015

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

Recalled by Mead Johnson Nutrition

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Reason for Recall

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.

Product Details

Product Quantity

235 cases

Product Type

Food

Code Info

Batch # EV5A6F

Voluntary/Mandated

Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern

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

Company Location

Evansville, IN, 47721

Timeline

Report Date

05/13/2015

Recall Initiated

03/26/2015

Classification Date

05/05/2015

Termination Date

10/27/2015

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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