Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu,
Check against the official notice below — it lists the full affected range.
PD-Rx Pharmaceuticals, Inc. is recalling 687 bottles of Losartan Potassium Tablets, USP 50 mg (90-tablet bottles) distributed nationwide. The recall was initiated because testing found that AZIDO impurity levels in the medication exceeded acceptable limits, which constitutes a deviation from current good manufacturing practices (CGMP). The affected bottles span multiple lot numbers with expiration dates ranging from August 2022 through January 2023.
The recall involves 13 specific lot numbers: D21D63, E21A73, E21D35, F21A28, F21D04, G21B03, G21E23, H21B46, H21D46, I21B67, J21A26, and J21C44. The source document does not specify what remedy consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Distribution: Nationwide Quantity: 687 bottles Lot/code info: 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; H21D46 Exp. 08/31/23; I21B67 Exp. 01/31/23; J21A26 Exp. 01/31/23; J21C44 Exp. 01/31/23
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.