Multi-event March 2016 FDA Recall Drug by Akorn, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Akorn, Inc. on March 23, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0875-2016
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
03-23-2016
06-01-2016
3,112,657 mL
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akorn, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
11-30-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration 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
Recall Number: D-0876-2016
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
03-23-2016
06-01-2016
294,090 mL
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akorn, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
11-30-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration 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
Recall Number: D-0874-2016
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
03-23-2016
06-01-2016
33,862 mL
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Akorn, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
11-30-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17
