Akorn, Inc. recalls Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups
Recalled April 4, 2018 · FDA recall D-0611-2018 · Akorn
Hazard
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. · FDA Class III
Units
56,1800 unit dose cups
Sold at
Nationwide in the USA
Description
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
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.
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →