The Recall Desk

FDA (Drugs) recall action 90176

Novartis Pharmaceuticals Corporation recalled 4 products on 2022-06-15

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2022-06-15
Critical
0
Units
2,999,312

Why these products were recalled

Failed Impurities/Degradation Specifications.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Drugs)··2022-06-15

    Xiidra Ophthalmic Solution Recalled for Failed Impurity and Degradation Specifications

    Novartis is recalling Xiidra (lifitegrast ophthalmic solution) 5% professional samples nationwide due to failed impurities and degradation quality specifications. The recall affects 279,179 vials across three lot numbers.

    Product
    Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 0242
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-06-15

    Xiidra ophthalmic solution recalled for failed impurity and degradation specifications

    Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.

    Product
    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,
    Category
    Distribution
    0 states