Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Recall Number: D-1060-2020
Firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Classification: Class II
Status: Terminated
Report Date: 20200401
Initiation Date: 20200319
Termination Date: 20210922
Reason for Recall
SubPotent Drug: Low out-of-specification results for assay testing.
Product Description
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.