Recalls / Class II

Class IIF-1540-2014

Product

Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES"

Type

Food

Affected lot / code info

Lot # L31056Z200, List # 54598-934(13) & USE BY 2015FE1; Lot L27385Z200 List # 54598-934(13) USE BY 2014OC1 & Lot L30698Z200 List # 54598 -934(13) USE BY 2015JA1

Quantity

Lot # L31056Z200-249cs/3 ctns/50/0.9 oz packets; Lot L27385Z200-328 cs/3 ctns/50/0.9 oz packets & Lot L30698Z200-349 cs/3 ctns/50/0.9 oz packets.

Why it was recalled

Abbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to enter the packet causing food oxidation and/or the powder to leak

Recalling firm

Firm

Abbott Nutrition

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

3300 Stelzer Rd, Columbus, Ohio 43219-3034

Distribution

Distribution pattern

All product in these lots were shipped to Canada.

Timeline

Recall initiated

2013-10-11

FDA classified

2014-02-20

Posted by FDA

2014-02-26

Terminated

2014-04-11

Status

Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-1540-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.