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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64846

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

Open FDA event record

Event summary

Timeline bucket
March 22, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Actavis South Atlantic LLC

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

buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.

D-248-2013
Recall number
D-248-2013
Initiated
March 22, 2013
Classification
Class III
Status
Terminated
Quantity
555,672 bottles

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 USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.

Code information

Lot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13; CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13; CF1D01A, CE1D24A, CF1D02A, Exp 05/13; CH1D08A, CH1D09A, Exp 07/13; CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13; CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13; CL1D08A, CM1D01A, CM1D02A, Exp 11/13

Distribution pattern

Nationwide