Exact FDA event identifier

Event 77411

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

Event summary

Timeline bucket: May 30, 2017
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Mckesson Packaging 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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 HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10

D-0928-2017

Recall number: D-0928-2017
Initiated: May 30, 2017
Classification: Class III
Status: Terminated
Recalling firm: Mckesson Packaging Services
Quantity: 942 cartons

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 Moisture Limits: Product tested out-of-specification for moisture content.

Code information

Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18

Distribution pattern

Nationwide in the US