D-0015-2021 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 14, 2020
- Initiation Date
- September 9, 2020
- Termination Date
- February 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13480 cups
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
Distribution Pattern
Nationwide.
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