Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Mac
Summary
The FDA issued a Class II for Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-coun by MACLEODS PHARMA USA, INC. Reason: Presence of foreign substance: plastic-like substance..
Details
Source
Drug Recall
External ID
D-0498-2024
Action Date
2024-05-22
Status
Ongoing
Category
drug
Product Description
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
Lot/Code Info: Lot #: BLK2304A, Exp. 07/31/2025
Quantity Affected: 1,048 bottles
Reason for Recall
Presence of foreign substance: plastic-like substance.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-07
Company
Princeton, 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 37 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-0498-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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