Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Summary
The FDA issued a Class II for Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, by Preferred Pharmaceuticals, Inc.. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Details
Source
Drug Recall
External ID
D-0892-2022
Action Date
2022-06-01
Status
Terminated
Category
drug
Product Description
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Lot/Code Info: Lot: K1721E, EXP: 4/30/2023, NDC: 68788-7758-03; Lot: H3021Q, EXP: 2/28/2023, NDC: 68788-7758-03.
Quantity Affected: 47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution
Within the U.S in FL and CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-03
Company
Anaheim, CA
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.
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 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 (Preferred 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 Preferred Pharmaceuticals, Inc. have FDA actions?
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0892-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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