Akorn, Inc. recalls Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville
Recalled April 10, 2019 · FDA recall D-1080-2019 · Akorn
Hazard
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. · FDA Class III
Units
2,796 bottles
Sold at
AR and MS
Description
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Product
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →