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.
Reason for recall: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Recall initiated: 20180329
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated