FDA recall F-1041-2016

Product

The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz. , Container description : Metal Can, Total package size : 24 cans per case .

Reason for recall

Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, smell, taste or texture  inconsistent with other lots of PediaSure Grow & Gain Vanilla. Abbott Nutrition also recognized a complaint trend for physical stability and sensory on this batch on 1/25/16 and an investigation revealed a possibility that a small portion of cans may

Distribution

Lot 57642RA00, Beginning Date of distribution in US  10/12/15 End Date of distribution in US- 12/4/15 . AN distributed this lot to151 Distributors, 32 Medical Facilities and 25 Other types of consignees (2 of these were internal sales reps). No foreign accounts. There are 12 US government consignees.

Key facts

Status

Terminated

Initiation date

2016-03-10

Report date

2016-04-13

Termination date

2016-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Altavista, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1041-2016