Exact FDA event identifier

Event 77110

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

Open FDA event record

Event summary

Timeline bucket: January 04, 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

Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10

D-0680-2017

Recall number: D-0680-2017
Initiated: January 04, 2017
Classification: Class III
Status: Terminated
Recalling firm: Mckesson Packaging Services
Quantity: 476 cartons (10x10 blister packs per carton)

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

Supotent: Out of Specification result for assay test during routine stability testing.

Code information

Lot #0111593, Exp. 05/2017

Distribution pattern

CO, LA and OH.