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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75030

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

Open FDA event record

Event summary

Timeline bucket
August 04, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Amerisource Health Services

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, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03

D-1501-2016
Recall number
D-1501-2016
Initiated
August 04, 2016
Classification
Class III
Status
Terminated
Quantity
2626 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 dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

Code information

Lot #: MS1509, Exp 12/17

Distribution pattern

Nationwide and Puerto Rico