FDAFDA · Food and drugs·Recall number D-1088-2017
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.
Published August 23, 2017 · Recall initiated: July 12, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization with subpotent out of specification assay results for chlorhexidine.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot: 353394, Exp 10-2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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