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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92380

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

Open FDA event record

Event summary

Timeline bucket
May 22, 2023
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
Aurobindo Pharma 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

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.

D-0765-2023
Recall number
D-0765-2023
Initiated
May 22, 2023
Classification
Class II
Status
Completed
Recalling firm
Aurobindo Pharma USA Inc.
Quantity
87,360 bottles

App-derived interpretation

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

Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

Code information

Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023

Distribution pattern

The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.