FDA-Drug2018-04-04Class III
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.
Akorn, Inc.
Hazard
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Sold states
Nationwide in the USA
Affected count
56,1800 unit dose cups
Manufactured in
1925 W Field Ct Ste 300, Lake Forest, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0611-2018Don't want to check this manually?
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