D-0983-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2022
- Initiation Date
- May 10, 2022
- Termination Date
- February 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,253,862 vials
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.
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution Pattern
Nationwide within the United States
Code Information
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