The Recall Desk

FDA (Drugs) recall action 73491

Akorn, Inc. recalled 3 products on 2016-06-01

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-06-01
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • ModerateFDA (Drugs)··2016-06-01

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.

    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
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-06-01

    Akorn Recalls PerioRx Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.

    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
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2016-06-01

    Akorn Recalls ORIS Chlorhexidine Oral Rinse Due to Impurity

    Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse because multiple batches failed impurity specifications.

    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
    Category
    Distribution
    1 state