Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDI...

FDA Recall #F-1540-2014 — Class II — October 11, 2013

Recall Summary

Recall NumberF-1540-2014
Date InitiatedOctober 11, 2013
ClassificationClass II
StatusTerminated
TypeVoluntary: Firm initiated
Product TypeFood

Recalling Firm

FirmAbbott Nutrition
LocationColumbus, OH

Product Description

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"

Reason for Recall

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

Classification

Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Distribution Pattern

All product in these lots were shipped to Canada.

Product 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.

Product Codes / Lot Numbers

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

What Should You Do?

Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.

Frequently Asked Questions

Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.

In most cases, yes. Retailers are typically notified to accept returns of recalled products and issue refunds, regardless of whether you have a receipt. Check with the store where you purchased the item. Some manufacturers also offer direct refunds — contact the recalling firm using the information in the official recall notice. If you purchased the product online, contact the retailer's customer service with your order number. In either case, you generally do not need original packaging, though retaining the product label with the lot code or UPC can speed up the process.

Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.

The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.