FDA Drug recall D-0015-2021
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc
- FDA Drug
- Class III
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class III recall of Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc by Pai Holdings, citing failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0015-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-09-09 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pai Holdings |
| Distribution | US |
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
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0015-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.