Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, In
Summary
The FDA issued a Class II for Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed an by PD-Rx Pharmaceuticals, Inc.. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Details
Source
Drug Recall
External ID
D-1163-2022
Action Date
2022-07-06
Status
Terminated
Category
drug
Product Description
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
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
Quantity Affected: 1320 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-1163-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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