Recalls / Class III
Class IIID-1088-2017
Product
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.
- Affected lot / code info
- Lot: 353394, Exp 10-2018
Why it was recalled
Crystallization with subpotent out of specification assay results for chlorhexidine.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 541,900 unit dose cups (5,419 trays)
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-07-12
- FDA classified
- 2017-08-14
- Posted by FDA
- 2017-08-23
- Terminated
- 2018-06-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1088-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.