← FDA ENFORCEMENT
D-0196-2024Class II

CARDINAL HEALTHCARE

Recalling firm
CARDINAL HEALTHCARE
Product type
Drug
Status
Terminated
Report date
2024-01-03
Distribution
Nationwide USA
Firm state
OH
Product quantity
1 unit
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Product description

RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03

Code / lot info

Batch P0248AL0AT

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.