Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-cou
Summary
The FDA issued a Class II for Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-coun by Macleods Pharma Usa Inc. Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Details
Source
Drug Recall
External ID
D-0835-2022
Action Date
2022-05-11
Status
Terminated
Category
drug
Product Description
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Lot/Code Info: Lot # BLK2107B, exp. date 05/2023 BLK2101A, exp. date 01/2025 BLK2102A, exp. date 02/2025 BLK2103B, exp. date 02/2023 BLK2103C, exp. date 02/2023 BLK2104A, exp. date 05/2023
Quantity Affected: N/A
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution
Product was distributed nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-15
Company
Plainsboro, NJ
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 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Macleods Pharma Usa Inc has 18 FDA actions in our database, including 18 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 (Macleods Pharma Usa Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Macleods Pharma Usa Inc have FDA actions?
Macleods Pharma Usa Inc has 18 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0835-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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