Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775
Summary
The FDA issued a Class III for Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: by Lupin Pharmaceuticals Inc.. Reason: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concent.
Details
Source
Drug Recall
External ID
D-0326-2022
Action Date
2022-01-12
Status
Terminated
Category
drug
Product Description
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Lot/Code Info: Lot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022
Quantity Affected: 50,832 bottles
Reason for Recall
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Distribution
Nationwide in the USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-22
Company
Baltimore, MD
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 77 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 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 (Lupin 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 Lupin Pharmaceuticals Inc. have FDA actions?
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0326-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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