D-0341-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 5, 2021
- Initiation Date
- March 8, 2019
- Termination Date
- June 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 576 bottles
Product Description
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
Reason for Recall
CGMP deviation: Product found to contain trace amounts of NMBA
Distribution Pattern
AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
Code Information
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