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

FDA recall notice · announced October 14, 2020 · Pai Holdings, Llc. Dba Pharmaceutical Associates

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide.
Lot/code information: Lots: C1EE Exp. 04/2021, BD82 Exp. 11/2020, BD83 Exp. 11/2020, C16D Exp. 02/2021, C563 Exp. 11/2021, C574 Exp. 11/2021
Quantity: 13480 cups
Status: Terminated
Products in this recall event:
- 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 (D-0015-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.