Losartan Potassium Tablets Recalled for Manufacturing Impurity Issues
PD-Rx Pharmaceuticals recalls Losartan Potassium Tablets (25 mg, 90-tablet bottles) due to Current Good Manufacturing Practice deviations. Specific lot numbers contain AZIDO impurity levels above acceptable limits.
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: FDA Class II recall involving drug quality deviations with potential health impact. No illnesses or hospitalizations have been reported in the source material, keeping the classification below Severe; however, manufacturing deviations affecting prescription medication constitute a significant risk-of-harm product.
Plain-English summary
PD-Rx Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets, USP 25 mg in 90-tablet bottles due to deviations from Current Good Manufacturing Practice standards. Manufacturing testing identified AZIDO impurity levels in certain lots that exceed acceptable limits.
Affected lot numbers are: D21C18, E21A28, E21C04, E21D59, G21B65, H21A12, H21D42, K21D19, and A22A73, with expiration dates ranging from 09/30/22 to 10/31/22. The product was manufactured by Vivimed Life Sciences Private Limited in India and distributed nationwide with National Drug Code 72789-163-90.
Patients who have these specific lot numbers should contact their healthcare provider or pharmacist regarding their medication supply. A total of 1,441 bottles have been recalled.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Category
- Drug
- Hazard
- azido-impurity
- manufacturing-deviation
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 (9)
- Lots: D21C18 Exp. 09/30/22
- E21A28 Exp. 09/30/22
- E21C04 Exp. 09/30/22
- E21D59 Exp. 09/30/22
- G21B65 Exp. 09/30/22
- H21A12 Exp. 09/30/22
- H21D42 Exp. 09/30/22
- K21D19 Exp. 10/31/22
- A22A73 Exp. 10/31/22
UPCs (4)
- 0372789163901
- 0372789164908
- 0372789165905
- 372789163901
Distribution
Distributed nationwide across the United States.
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