RecallHawk
Class I Recall

Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 can

Abbott Laboratories

Summary

The FDA issued a Class I for Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palst by Abbott Laboratories. Reason: Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil.

Details

Source

Food Recall

External ID

F-0943-2022

Action Date

2022-03-16

Status

Ongoing

Category

food

Product Description

Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 cans per case. Item numbers: 68063 68065 68109 Retail UPCs: 070074680644 070074680668 070074681108

Lot/Code Info: Batches: 33737SH00 33738SH00 33739SH00 35974SH00 35975SH00 36097SH00 36229SH01 32372SH00 32435SH00 32436SH00 36085SH00 36230SH00 37314SH00 32592K800 32595K800 35011K800 36138K800 36139K800 36231K800 36232K800 37291K800 37313K800

Quantity Affected: 342054 cases

Reason for Recall

Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced

Distribution

US Nationwide. Worldwide.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-02-17

Company

Abbott Laboratories

Abbott Park, IL

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 92 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Abbott Laboratories have FDA actions?

Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0943-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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