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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77601

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 19, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Apace KY 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

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

Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15

D-1035-2017
Recall number
D-1035-2017
Initiated
June 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Apace KY LLC
Quantity
1,483 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling; Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg

Code information

Lot: 16710, exp 07/2018

Distribution pattern

KY

drug · product 2 of 2

Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15

D-1036-2017
Recall number
D-1036-2017
Initiated
June 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Apace KY LLC
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling; Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg

Code information

Lot: 16710, exp 07/2018

Distribution pattern

KY