Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containe
Summary
The FDA issued a Class III for Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Contai by Novartis Pharmaceuticals Corporation. Reason: Failed Impurities/Degradation Specifications..
Details
Source
Drug Recall
External ID
D-0983-2022
Action Date
2022-06-15
Status
Terminated
Category
drug
Product Description
Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
Lot/Code Info: Lot #: a) and b)19E31, 19E32, 19E85, 19E86, 19EC0, 19EG8 & 19EG9, Exp. Date 05/2022; 19F13, 19FB0 & 19FC5, Exp. Date 6/2022;19G33, 19G34,19GJ8, Exp. Date 07/2022;19M25, 19M26 & 19M68, Exp. Date 08/2022;19NC0, 19NC1, 19NF2,19NF3, Exp. Date 09/2022;19P26, 19P59, 19P60,19P85,19P86 19P87, Exp. Date 10/2022;19S55, 19S03, 19S04, 19S05,19S07, Exp. Date 11/2022; 19T06, 19T60, 19T61, Exp. Date 12/2022; 20A38, 20A39, 20A64, 20A65, 20AA1, 20AA2, 20AC8, 20AC9, 20AE7, Exp. Date 01/2023; 20B24, 20B25, 20B55, 20B56, 20B57 & 20B58, Exp. Date 02/2023
Quantity Affected: 1,253,862 vials
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-10
Company
East Hanover, 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 180 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Novartis Pharmaceuticals Corporation has 6 FDA actions in our database, including 6 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 (Novartis Pharmaceuticals Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novartis Pharmaceuticals Corporation have FDA actions?
Novartis Pharmaceuticals Corporation has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0983-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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