SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM
Summary
The FDA issued a Class I for SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bott by Novartis Pharmaceuticals Corp.. Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals..
Details
Source
Drug Recall
External ID
D-1174-2023
Action Date
2023-09-27
Status
Ongoing
Category
drug
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.
Lot/Code Info: FX001691, Exp. 12/31/2025
Quantity Affected: 1272 bottles
Reason for Recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-08
Company
East Hanover, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novartis Pharmaceuticals Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novartis Pharmaceuticals Corp. have FDA actions?
This is the only FDA action we have on record for Novartis Pharmaceuticals Corp. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1174-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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