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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73491

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

Open FDA event record

Event summary

Timeline bucket
March 23, 2016
Product types
Drug
Classifications
Class II
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

ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O

D-0874-2016
Recall number
D-0874-2016
Initiated
March 23, 2016
Classification
Class II
Status
Terminated
Recalling firm
Akorn, Inc.
Quantity
33,862 mL

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 impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.

Code information

Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 3

Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16

D-0875-2016
Recall number
D-0875-2016
Initiated
March 23, 2016
Classification
Class II
Status
Terminated
Recalling firm
Akorn, Inc.
Quantity
3,112,657 mL

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 impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.

Code information

Lot # 627528, 627763, 627766, 627921, 627924, 627927, 627930, 627933, 627953, 627956, 627959, 628040, Exp 5/16; 628148, 628151, 628230, 628232, 628365, Exp 6/16; 628589 , 628592, 628598, 628802, 628805, 628808, 628811, 628814, Exp 7/16 ; 629059, 629204, 629207, 629232, 629235, 629307, 629310, 629313, 629316, Exp 8/16; 629687, 629693, 629696, 629882, 629888, 630058, Exp 9/16; 630061, 630064, 630221, 630224, 630362, 630365, 630613, Exp 10/16; 630615, 630732, 630735, 630853, 630856, 630859, 631008, Exp 11/16; 631026, 631027, 631169, 631172, 631175, 631655, 631658, Exp 12/16; 631704, 631707, 631861, 631864, 631867, 632059, 632062, 632065, 632068, 632071, 632074, 632211, 632214 Exp 1/17; 632328, 632331, 632334, 632337, 632472, 632475, 632504, 632507, 632697, Exp 2/17; 633090, 633093, 632776, 632781, 632784, 632790, 632793, 632796, 632805, 632808, 632811, 632814, 633072, 633078, 633081, 633084, 633087, Exp 3/17; 633681, 633682, 633099, 633684, 633111, Exp 4/17; 345607, 345618, 345620, Exp 5/17; 346575, 346863, 346571, 346720,3 46573, Exp 7/17

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 3

PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701

D-0876-2016
Recall number
D-0876-2016
Initiated
March 23, 2016
Classification
Class II
Status
Terminated
Recalling firm
Akorn, Inc.
Quantity
294,090 mL

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 impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.

Code information

Lot # 627525, Exp 5/16; 628362, Exp 6/16; 628595, Exp 7/16; 629319, Exp 8/16; 629885, Exp 9/16; 630467,Exp10/16; 32218, 632500, Exp 2/17; 633075, 632799, Exp 3/17; 345624, 345679, Exp 5/17; 347420, 347662, Exp 9/17

Distribution pattern

Nationwide and Puerto Rico