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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77822

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

Open FDA event record

Event summary

Timeline bucket
July 12, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Akorn Inc

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

3 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 3

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.

D-1088-2017
Recall number
D-1088-2017
Initiated
July 12, 2017
Classification
Class III
Status
Terminated
Recalling firm
Akorn Inc
Quantity
541,900 unit dose cups (5,419 trays)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization with subpotent out of specification assay results for chlorhexidine.

Code information

Lot: 353394, Exp 10-2018

Distribution pattern

Nationwide in the USA

drug · product 2 of 3

Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012

D-1089-2017
Recall number
D-1089-2017
Initiated
July 12, 2017
Classification
Class III
Status
Terminated
Recalling firm
Akorn Inc
Quantity
40,978 unit dose cups

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization with subpotent out of specification assay results for chlorhexidine.

Code information

Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018.

Distribution pattern

Nationwide in the USA

drug · product 3 of 3

Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014

D-1090-2017
Recall number
D-1090-2017
Initiated
July 12, 2017
Classification
Class III
Status
Terminated
Recalling firm
Akorn Inc
Quantity
101,952 15 mL unit dose cups

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization with subpotent out of specification assay results for chlorhexidine.

Code information

Lots: 0202635072, 0202635073, EXP 06-2018; 0202630205, 0202630206, EXP 07-2018; 0202630203, 0202630204, 0202642217, 0202642218, 0202642219, 0202647410, 0202647411, EXP 08-2018; 0202647409, 0202647412, 0202653431, 0202653432, EXP 09-2018.

Distribution pattern

Nationwide in the USA