Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail…
Abbott Laboratories recalled this product and the FDA reported the enforcement action on 16 March 2022 as Class I. The recall was initiated by the firm. 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
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 070074545998 055325545996 070074109404 070074103297 070074671833
- 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
- Recalling firm
- Abbott Laboratories
- Firm location
- Abbott Park, Illinois, United States
- Classification
- Class I
- Status
- Ongoing
- Recall number
- F-0919-2022
- Quantity
- 104146 cases
- Distribution
- US Nationwide. Worldwide.
- Initiated
- 17 February 2022
- Reported by FDA
- 16 March 2022
- Firm notified by
- Press Release
- Product codes
- Batches: 22349Z200 25609Z200 26914Z200 26915Z200 26916Z200 26917Z200 26918Z200 26919Z200 26920Z200 26921Z200 27073Z200 28077Z200 28158Z200 28162Z200 28166Z200 29385Z200 30512Z200 30513Z200 30521Z200 31525Z200 31533Z200 31534Z200 31543Z200 32649Z200 32655Z200 32656Z200 32660Z200 32660Z210 32671Z200 33751Z200 33752Z200 34045Z200 34046Z210 34892Z200 34901Z200 35112Z200 35113Z200 35163Z200 36170Z200 30522Z200 32657Z200 22353Z200 22354Z200 26782Z200 26785Z200 27982Z200 27983Z200 31541Z200 33753Z200 34890Z200 34891Z200 35164Z200 36171Z200 24472Z200 25610Z200 27984Z200 32672Z200 32673Z200 32674Z200 22296Z200 22297Z200 25712Z200 26781Z200 26786Z200 26787Z200 30514Z200 30523Z200 31524Z200 31532Z200 31542Z200 32658Z200 33659Z200 33756Z200 33757Z200 34889Z200 36169Z200 22350Z200 22351Z200 22352Z200 22355Z200 22356Z200 22357Z200 23358Z200 23359Z200 24465Z200 24466Z200 24467Z200 24468Z200 24469Z200 24470Z200 24471Z200 25605Z200 25606Z200 25607Z200 25608Z200 25611Z200 25612Z200 25613Z200 25614Z200 25705Z200 25706Z200 25707Z200 25708Z200 25709Z200 25710Z200 25711Z200 25713Z200 25714Z200 26772Z200 26777Z200 26778Z200 26779Z200 26783Z200 26784Z200 26852Z200 26853Z200 27074Z200 27854Z200 27855Z200 27856Z200 27857Z200 27985Z200 27986Z200 28075Z200 28078Z200 28079Z200 28080Z200 28159Z200 28160Z200 28161Z200 28163Z200 28164Z200 28165Z200 30515Z200 30516Z200 30519Z200 30520Z200 31526Z200 31527Z200 31528Z200 31529Z200 31530Z200 31531Z200 31535Z200 31536Z200 31537Z200 31538Z200 31539Z200 31540Z200 32650Z200 32651Z200 32652Z200 32653Z200 32654Z200 32675Z200 33661Z200 33743Z200 33744Z200 33745Z200 33746Z200 33747Z200 33748Z200 33749Z200 33750Z200 33754Z200 33755Z200 33885Z200 33886Z200 34043Z200 34044Z200 34887Z200 34888Z200 34893Z200 34894Z200 34895Z200 34896Z200 34897Z200 34898Z200 34899Z200 34900Z200 34902Z200 34903Z200 34904Z200 34905Z200 35110Z200 35111Z200 28076Z200
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 41 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 41 separate recalls, which almost every published figure does, overstates it by a factor of 41. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 41 of them.
- This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
- The FDA published the enforcement report 4 weeks after the firm began the recall.
- Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
What this recall was for
Salmonella
Salmonella is a bacterium that survives in low-moisture foods for months, which is why it appears in recalls of products that carry no water for it to grow in: nut butters, spices, flour and dry pet food.
A preventive controls plan covers Salmonella contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.135(c)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 117.165(a)(2)
- Product testing: testing as a verification activity, appropriate to the facility, the food and the nature of the preventive control.
Filed under milk and dairy. A product can sit in more than one.
Other milk and dairy recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Abbott Laboratories
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 60 other records name this firm.
All 61 records for Abbott Laboratories
All 2022 recalls · All FDA food recall data
21 CFR 117.135(c)(1) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.