Eye Drops Recalled

Novartis Pharmaceuticals Corporation is recalling dozens of lots of Xiidra (lifitegrast ophthalmic solution) 5% for failing to meet impurities/degradation specifications. The recalls were included in the June 15, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following Xiidra products, which were distributed throughout the United States:

• cartons of 60 single-use containers (NDC 0078-0911-12) and 5 single-use containers (NDC 0078-0911-05), manufactured by the Ritedose Corporation, Columbia, SC, and distributed by Novartis, from lots 20E21, 20E22, 20E53, 20E54, 20E95, 20E96, 20ED1, 20ED2, 20ED3, and 20EK1 (Exp. 4/23); 20F27, 20F28, 20F66, 20F67, and 20FH6 (Exp. 5/23); 20G47, 20G48, 20G49, 20G57, 20GB8, 20GE5, and 20GE6 (Exp. 6/23); 20M41, 20M42, 20M56, 20M66, 20M67, and 20MA4 (Exp. 7/23); 20S20, 20S22, 20S44, and 20S94 (Exp. 10/23); 20SA6, 20SA7, and 20SE0 (Exp. 10/23); and 20TE2 and 20TG5 (Exp. 11/23);
• professional samples packaged in 5 single-use containers (NDC 0078-0911-95) and in 4 pouches of 5 single-use containers (NDC 0078-0911-94), manufactured by the Ritedose Corporation, and distributed by Novartis, from lot 20DJ3 (Exp. 3/23);
• cartons of 60 single-use containers (NDC 54092-606-01) and 5 single-use containers (NDC 54092-606-06) manufactured for Shire US Inc., from lots 19E31, 19E32, 19E85, 19E86, 19EC0, 19EG8, and 19EG9 (Exp. 5/22); 19F13, 19FB0, and 19FC5 (Exp. 6/22); 19G33, 19G34, and 19GJ8 (Exp. 7/22); 19M25, 19M26, and 19M68 (Exp. 8/22); 19NC0, 19NC1, 19NF2, and 19NF3 (Exp. 9/22); 19P26, 19P59, 19P60, 19P85, 19P86, and 19P87 (Exp. 10/22); 19S55, 19S03, 19S04, 19S05, and 19S07 (Exp. 11/22); 19T06, 19T60, and 19T61 (Exp. 12/22); 20A38, 20A39, 20A64, 20A65, 20AA1, 20AA2, 20AC8, 20AC9, and 20AE7 (Exp. 1/23); and 20B24, 20B25, 20B55, 20B56, 20B57, and 20B58 (Exp. 2/23); and
• professional samples packaged in 5 single-use containers (NDC 54092-606-07) and in 4 pouches of 5 single-use containers (NDC 54092-606-04) manufactured for Shire US Inc, from lots 19F39 (Exp. 6/22); 19P27 (Exp. 10/22); and 20CD1 (Exp. 3/23).

Novartis voluntarily initiated the recall May 10, 2022. On June 6, 2022, the FDA designated the recall Class III, signaling that use of the recalled eye drops is not likely to cause harm.

Xiidra is a prescription medication used to treat signs and symptoms of dry eye disease.