Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40

Recall Number: D-0015-2021

Firm: PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Classification: Class III

Status: Terminated

Report Date: 20201014

Initiation Date: 20200909

Termination Date: 20220222

Reason for Recall

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

Product Description

Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40