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.
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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
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
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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.