Recalls / Class III
Class IIID-0611-2018
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.
- Affected lot / code info
- Lot #: 350836, Exp 05/18
Why it was recalled
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 56,1800 unit dose cups
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-03-29
- FDA classified
- 2018-03-29
- Posted by FDA
- 2018-04-04
- Terminated
- 2020-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0611-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.