PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: October 14, 2020 Initiated: September 9, 2020 #D-0015-2021

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

Reason for Recall

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

Details

Units Affected
13480 cups
Distribution
Nationwide.
Location
Greenville, SC

Frequently Asked Questions

What product was recalled?
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. Recalled by PAI Holdings, LLC. dba Pharmaceutical Associates Inc. Units affected: 13480 cups.
Why was this product recalled?
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Which agency issued this recall?
This recall was issued by the FDA Drug on October 14, 2020. Severity: Low. Recall number: D-0015-2021.