Product Safety Recalls

Product Recall Tracker

Recall D-0181-2024

Description: FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10

Recall D-0181-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0181-2024
Event ID89450
DistributionNationwide USA
Quantity1 unit
Recall ReasonCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Drug ClassificationClass II
Drug Code Info20240103
Recall Initiation Date20220126
Report Date20240103
Classification Date20231226
Address7200 Cardinal Pl W
Dublin, OH 43017-1094
United States
Initial Notification Letter
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