Drug 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
D-0015-2021
Product summary
- Event
- Event 86409
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13480 cups
- Official record key
drug-enforcement:D-0015-2021
Official wording
Reason: Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
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
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
out of specification