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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77881

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

Open FDA event record

Event summary

Timeline bucket
August 02, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Teva Pharmaceuticals USA

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

Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15

D-1058-2017
Recall number
D-1058-2017
Initiated
August 02, 2017
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
2,880 cartons (30 unit dose blister pack per carton)

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 Moisture Limits: out of specification test results for water content obtained during stability testing.

Code information

Lot # 3138405A, Exp 8/2017

Distribution pattern

Product distributed to OH, IL, PA, MI, VA and CT