Drug Enforcement D-1543-2022

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

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Status

Terminated

Classification

Class II

Report Date

October 5, 2022

Termination Date

March 11, 2024

Product Information

Product description
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Product quantity
132,999 cartons
Reason for recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Novartis Pharmaceuticals Corporation
Address
1 Health Plz, N/A

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

Codes & Dates

Recall number
D-1543-2022
Event ID
90862
Recall initiation date
September 16, 2022
Center classification date
September 26, 2022
Code info
Lot # APCD162, Exp. 01/2023
More code info
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