Why it was recalled
CGMP deviation: Product found to contain trace amounts of NMBA
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0341-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 8, 2019
- FDA report date
- May 5, 2021
- Quantity
- 576 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0341-2021, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 87774
- Address
- 727 N Ann Arbor Ave
- 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
- Postal code
- 73127-5822
- Report date
- May 5, 2021
- Product type
- Drugs
- Recall number
- D-0341-2021
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 576 bottles
- Termination date
- Jun 16, 2021
- Reason for recall
- CGMP deviation: Product found to contain trace amounts of NMBA
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
- Recall initiation date
- Mar 8, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 26, 2021