FDA recall F-2170-2015

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2015-03-26

Report date

2015-05-13

Termination date

2015-10-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Evansville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-2170-2015