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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88617

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 27, 2021
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
DuPont Nutrition USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

D-0830-2021
Recall number
D-0830-2021
Initiated
August 27, 2021
Classification
Class I
Status
Terminated
Recalling firm
DuPont Nutrition USA, Inc
Quantity
80 kg

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination
Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).

Code information

Lot # 2173766940

Distribution pattern

Product was distributed to one account that may have used it as a component in finished drug formulations, and further distributed Nationwide in the USA.