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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83436

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

Open FDA event record

Event summary

Timeline bucket
July 29, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
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

Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99

D-1842-2019
Recall number
D-1842-2019
Initiated
July 29, 2019
Classification
Class III
Status
Terminated
Recalling firm
Aurobindo Pharma USA Inc.
Quantity
2,352/1000 count bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling; Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

Code information

05318054B, exp 3/2021

Distribution pattern

Product was distributed nationwide by three major distributors who may have further distributed the product.