Drug Enforcement D-1174-2023

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Status

Ongoing

Classification

Class I

Report Date

September 27, 2023

Termination Date

—

Product Information

Product description
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
Product quantity
1272 bottles
Reason for recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Novartis Pharmaceuticals Corp.
Address
1 Health Plz

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1174-2023
Event ID
92975
Recall initiation date
September 8, 2023
Center classification date
September 21, 2023
Code info
FX001691, Exp. 12/31/2025
More code info
—