Recall events
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Event 63127
Event summary
Timeline bucket March 29, 2012
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
2 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 2
buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910.
D-001-2013
Recall number D-001-2013
Initiated March 29, 2012
Classification Class III
Status Terminated
Quantity 187 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 USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Code information Lot #: 0074583, Exp. Date 03/12
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5538]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 2
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010.
D-002-2013
Recall number D-002-2013
Initiated March 29, 2012
Classification Class III
Status Terminated
Quantity 674 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 USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Code information Lot #: 0075375, 0074584, Exp 08/12
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5507]
FDA event record
· Exact recall-number query on openFDA
