The Recall Desk

FDA (Drugs) recall action 79635

Akorn, Inc. recalled 3 products on 2018-04-04

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
2018-04-04
Critical
0
Units
630,563

Why these products were recalled

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • LowFDA (Drugs)··2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Oral Rinse Kits

    Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.

    Product
    24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-04-04

    Akorn Recalls 24-Hour Oral Care Kits Due to Low Chlorhexidine Levels

    Akorn, Inc. is recalling 24-Hour Oral Care q2 Kits because the chlorhexidine gluconate oral rinse contained in some units had low potency levels.

    Product
    24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Gluconate Oral Rinse Unit Dose Cups

    Akorn, Inc. is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups due to product crystallization and low assay results.

    Product
    Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
    Category
    Distribution
    0 states