FDA-Drug2022-07-06Class II
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, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5
PD-Rx Pharmaceuticals, Inc.
Hazard
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Sold states
Nationwide
Affected count
1320 bottles
Manufactured in
727 N Ann Arbor Ave, Oklahoma City, OK, United States
Products
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, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1163-2022Don't want to check this manually?
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