September 2020 FDA Recall Drug by Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
D-0015-2021 - Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

This Class III drug recall was voluntarily initiated by Pai Holdings, Llc. Dba Pharmaceutical Associates Inc on September 9, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; high out of specification results obtained at the 9 month stability timepoint. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0015-2021

Reason for Recall
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Initiated
09-09-2020
Reported
10-14-2020
Quantity
13480 cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86409
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2022
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# 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