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
Recall Number: D-1080-2019
Firm: Akorn, Inc.
Classification: Class III
Status: Terminated
Report Date: 20190410
Initiation Date: 20190328
Termination Date: 20200422
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Product Description
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