Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans
Summary
The FDA issued a Class I for Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, 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-0929-2022
Action Date
2022-03-16
Status
Ongoing
Category
food
Product Description
Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans per case Item numbers: 6676006 6676012 6676021 6676025 6676030 6676045 6676053 6676057 Retail UPCs: 8699548995217 0070074124155 0070074123851 0070074120195 070074120850 070074122502 0070074120157
Lot/Code Info: Batches: 25557Z200 27930Z200 28130Z201 29266Z200 30374Z200 30384Z201 32422Z201 33693Z200 36144Z202 25557Z201 30384Z202 33693Z202 34767Z201 35031Z202 36144Z205 27930Z202 36144Z203 25557Z203 30374Z202 36144Z204 34767Z202 25557Z205 28130Z200 29266Z201 30384Z200 32422Z202 33693Z201 35031Z201 36144Z200 25557Z204 28130Z202 30374Z201 32422Z210 34767Z200 35031Z200 36144Z201 25557Z202 27930Z201 28130Z203
Quantity Affected: 95077 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 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-0929-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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