Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc.
Summary
The FDA issued a Class II for Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and by PD-Rx Pharmaceuticals, Inc.. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Details
Source
Drug Recall
External ID
D-1162-2022
Action Date
2022-07-06
Status
Terminated
Category
drug
Product Description
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, India NDC 72789-164-90 UPC 3 72789 16490 8
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
Quantity Affected: 687 bottles
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-06
Company
Oklahoma City, OK
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
PD-Rx Pharmaceuticals, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PD-Rx Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PD-Rx Pharmaceuticals, Inc. have FDA actions?
PD-Rx Pharmaceuticals, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1162-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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