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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77109

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

Open FDA event record

Event summary

Timeline bucket
April 24, 2017
Product types
Drug
Classifications
Class II
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

Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel

D-0705-2017
Recall number
D-0705-2017
Initiated
April 24, 2017
Classification
Class II
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
N/A

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products

Code information

100 (NDC 0093-4359-01) and 500 count bottles (NDC 0093-4359-05)- Lot # 07C160; Exp. 03/18 100 Unit Dose Blisters/Carton (NDC 0093-4359-93) and Individual Blister Pack (NDC 0093-4359-19) - Lot # 07C160A; Exp. 03/18

Distribution pattern

Nationwide

Field note

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