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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64105

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

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Event summary

Timeline bucket
November 30, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
West-ward Pharmaceutical Corp.

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

VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA 30062-2260, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

D-189-2013
Recall number
D-189-2013
Initiated
November 30, 2012
Classification
Class II
Status
Terminated
Quantity
18,825 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.

Code information

68977A; 68977B; 68978B; 68978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013

Distribution pattern

GA