Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0
Summary
The FDA issued a Class III for Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: M by MACLEODS PHARMA USA, INC. Reason: Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles..
Details
Source
Drug Recall
External ID
D-0162-2023
Action Date
2023-01-25
Status
Terminated
Category
drug
Product Description
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
Lot/Code Info: Lot #: BLF2214A; Exp. 06/2025
Quantity Affected: 10052 bottles
Reason for Recall
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Distribution
Nationwide within United States and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-05
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 83 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0162-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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