FDA recall D-0015-2021

Product

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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2020-09-09

Report date

2020-10-14

Termination date

2022-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0015-2021