Recall Enforment Report D-0091-2022

Drug Recall Enforcement Report Class III voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 10-20-2021 for the product 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. The product was recalled due to failed stability specifications: out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88885 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0091-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide in the USA and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
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. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 16,272 bottles Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 11-03-2021
Recall Initiation Date 10-20-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Lupin Pharmaceuticals Inc.
Code Info Lot # H002512, exp. date March 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 68180-435-01
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68180-435Gatifloxacin GatifloxacinSolution/ DropsOphthalmicLupin Pharmaceuticals, Inc.Human Prescription Drug