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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64996

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

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Event summary

Timeline bucket
March 18, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Physicians Total Care, 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

Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA

D-499-2013
Recall number
D-499-2013
Initiated
March 18, 2013
Classification
Class III
Status
Terminated
Quantity
6 cards of 28 tablets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurity/Degradation Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Code information

Physicians Total Care Lots: 6Z4C Exp. 10/31/2013

Distribution pattern

MO

Field note

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