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Recall Observatory FDA recall evidence

Food product

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

F-2170-2015

March 26, 2015

Class II

Product summary

Firm
Mead Johnson Nutrition
Event
Event 70850
Status
Terminated
Classification
Class II
Quantity
235 cases
Official record key
food-enforcement:F-2170-2015

Official wording

Reason: 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.

Code information: Batch # EV5A6F

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.