Exact FDA event identifier

Event 67928

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 04, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Boehringer Ingelheim Roxane 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

2 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 2

Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25

D-1313-2014

Recall number: D-1313-2014
Initiated: April 04, 2014
Classification: Class III
Status: Terminated
Recalling firm: Boehringer Ingelheim Roxane Inc
Quantity: 8,304 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: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.

Code information

Lot 261983A Exp.11/15

Distribution pattern

Nationwide

drug · product 2 of 2

Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11

D-1314-2014

Recall number: D-1314-2014
Initiated: April 04, 2014
Classification: Class III
Status: Terminated
Recalling firm: Boehringer Ingelheim Roxane Inc
Quantity: 98,560 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: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.

Code information

Lot 261997A Exp 02/16; 262214V, 359283V Exp. 05/16

Distribution pattern

Nationwide