Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
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 02421.
Lot numbers, UPCs & expiration codes
Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, Exp. Date 03/2023
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0985-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 10, 2022
- FDA report date
- Jun 15, 2022
- Quantity
- 279,179 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corporation
Original FDA data
Every field from FDA enforcement report D-0985-2022, exactly as published.
Show all FDA fields
- City
- East Hanover
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90176
- Address
- 1 Health Plz
- Code information
- Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, Exp. Date 03/2023
- Postal code
- 07936-1016
- Report date
- Jun 15, 2022
- Product type
- Drugs
- Recall number
- D-0985-2022
- Classification
- Class III
- Recalling firm
- Novartis Pharmaceuticals Corporation
- Product quantity
- 279,179 vials
- Termination date
- Feb 28, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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 02421.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2022