RecallDepth
Class III Terminated

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

Company
Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
Recall Initiated
September 9, 2020
Posted
October 14, 2020
Recall Number
D-0015-2021
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
13480 cups
Firm Location
Greenville, SC, United States

Reason for Recall

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

Distribution

Nationwide.

Lot / 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

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