Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. F
Summary
The FDA issued a Class II for Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By by Direct Rx. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits ..
Details
Source
Drug Recall
External ID
D-0895-2022
Action Date
2022-06-01
Status
Terminated
Category
drug
Product Description
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Lot/Code Info: Lots: 08NO2102 Exp. 1/31/25; 17NO2118 Exp. 1/31/25; 18NO2123 Exp. 1/31/25; 25OC2114 Exp. 1/31/25; 22NO2105 Exp. 1/31/25
Quantity Affected: 11 bottles
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Distribution
FL
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-11
Company
Dawsonville, GA
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 101 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Direct Rx has 30 FDA actions in our database, including 30 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 (Direct Rx) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Direct Rx have FDA actions?
Direct Rx has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0895-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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