March 2019 FDA Recall Losartan Potassium by Pd-rx Pharmaceuticals, Inc.
D-0341-2021 - CGMP deviation

This Class II drug recall was voluntarily initiated by Pd-rx Pharmaceuticals, Inc. on March 8, 2019 for the product Losartan Potassium. The FDA reported the reason for recall as cgmp deviation. The product was distributed in AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY and the recall is currently terminated.

Recall Number: D-0341-2021

Reason for Recall
CGMP deviation: Product found to contain trace amounts of NMBA
Initiated
03-08-2019
Reported
05-05-2021
Quantity
576 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87774
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PD-Rx Pharmaceuticals, 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.
AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2021
Product Description About Product Description
Full technical description of the product.
Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90

Batch or Lot Expiration Information

Lot# Lots: A19B99 Exp. 11/30/2019; B19A26 Exp. 11/30/2019; B19A69 Exp. 11/30/2019; E18F12 Exp.: 09/30/19; F18A12 Exp.: 09/30/19; F18F06 Exp.: 09/30/19; G18B43 Exp.: 09/30/19; G18C43 Exp.: 09/30/19; G18F75 Exp.: 09/30/19; H18D55 Exp.: 09/30/19; I18A11 Exp.: 09/30/19; I18E32 Exp.: 09/30/19; J18A90 Exp.: 09/30/19; J18D50 Exp. 11/30/2019; L18D01 Exp. 11/30/2019

Affected Packages Involved in this Recall

43063-854-60 Losartan Potassium
43063-854-90 Losartan Potassium