Losartan Potassium tablets recalled for elevated AZIDO impurity
PD-Rx Pharmaceuticals recalled Losartan Potassium 50 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. The recall affects 687 bottles across multiple lots.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for manufacturing deviations with AZIDO impurity exceeding acceptable limits. No illnesses or injuries have been reported; the recall is preventive based on manufacturing control testing.
Plain-English summary
PD-Rx Pharmaceuticals, Inc. is recalling Losartan Potassium tablets, USP 50 mg, in bottles of 90 tablets (NDC 72789-164-90). The recall affects 687 bottles distributed nationwide. The product is manufactured by Vivimed Life Sciences Private Limited in India and marketed by PD-Rx Pharmaceuticals in Oklahoma City, Oklahoma.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing controls. Testing detected AZIDO impurity levels in affected lots that exceeded acceptable limits. Multiple lot numbers are affected, with expiration dates ranging from August 2022 to January 2023.
Patients taking Losartan Potassium should contact their healthcare provider or pharmacist to determine if their medication is from an affected lot. Consumers can check the specific lot numbers and expiration dates published by the FDA to identify affected product. Those with affected medication should consult their healthcare provider regarding appropriate action.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Category
- Drug
- Hazard
- azido-impurity
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lots: D21D63 Exp. 11/30/22
- E21A73 Exp. 11/30/22
- E21D35 Exp. 11/30/22
- F21A28 Exp. 11/30/22
- F21D04 Exp. 09/30/22
- G21B03 Exp. 11/30/22
- G21E23 Exp. 11/30/22
- H21B46 Exp. 11/30/22
- H21D46 Exp. 08/31/23
- I21B67 Exp. 01/31/23
- J21A26 Exp. 01/31/23
- J21C44 Exp. 01/31/23
UPCs (4)
- 0372789163901
- 0372789164908
- 0372789165905
- 372789164908
Distribution
Distributed nationwide across the United States.
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