Losartan Potassium Tablets, USP 100 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, Tamilnad
Check against the official notice below — it lists the full affected range.
PD-Rx Pharmaceuticals, Inc. is recalling 1,320 bottles of Losartan Potassium Tablets, USP 100 mg nationwide due to CGMP deviations involving azido impurity levels that were found to be above acceptable limits. The recalled bottles were manufactured by Vivimed and marketed by PD-Rx Pharmaceuticals in Oklahoma City, Oklahoma. The affected lots are G21C26, H21B96, I21B39, I21C44, D21F35, E21A66, E21C72, E21F01, F21C15, F21E19, G21B14, K21A61, and L21A45, with expiration dates ranging from July 31, 2022 through November 30, 2022.
The source document does not specify what consumers should do regarding this recall or whether a remedy is available.
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: 1320 bottles Lot/code info: Lots: G21C26 Exp. 07/31/22; H21B96 Exp. 07/31/22; I21B39 Exp. 07/31/22; I21C44 Exp. 07/31/22; D21F35 Exp. 10/31/22; E21A66 Exp. 10/31/22; E21C72 Exp. 10/31/22; E21F01 Exp. 10/31/22; F21C15 Exp. 10/31/22; F21E19 Exp. 10/31/22; G21B14 Exp. 10/31/22; K21A61 Exp. 11/30/22; L21A45 Exp. 11/30/22
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.