Recalls / Class II
Class IID-0341-2021
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
- Brand name
- Losartan Potassium
- Generic name
- Losartan Potassium
- Active ingredient
- Losartan Potassium
- Route
- Oral
- NDC
- 43063-854
- FDA application
- ANDA203835
- Affected lot / code info
- 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
Why it was recalled
CGMP deviation: Product found to contain trace amounts of NMBA
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, N/A, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 576 bottles
- Distribution pattern
- AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
Timeline
- Recall initiated
- 2019-03-08
- FDA classified
- 2021-04-26
- Posted by FDA
- 2021-05-05
- Terminated
- 2021-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0341-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.