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.
Reported: August 23, 2017 Initiated: July 12, 2017 #D-1088-2017
Product Description
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.
Reason for Recall
Crystallization with subpotent out of specification assay results for chlorhexidine.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- 541,900 unit dose cups (5,419 trays)
- Distribution
- Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn Inc. Units affected: 541,900 unit dose cups (5,419 trays).
Why was this product recalled? ▼
Crystallization with subpotent out of specification assay results for chlorhexidine.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 23, 2017. Severity: Low. Recall number: D-1088-2017.
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