Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Summary
The FDA issued a Class II for Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackag by RemedyRepack Inc.. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Details
Source
Drug Recall
External ID
D-0885-2022
Action Date
2022-06-01
Status
Terminated
Category
drug
Product Description
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Lot/Code Info: Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022
Quantity Affected: 22 bottles/90 count each
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution
Recalled product was distributed to Florida.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-04
Company
Indiana, PA
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 267 drug-related FDA actions this month.
RemedyRepack Inc. has 34 FDA actions in our database, including 34 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 (RemedyRepack Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RemedyRepack Inc. have FDA actions?
RemedyRepack Inc. has 34 FDA actions in our database, including 34 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0885-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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