D-0181-2024 Class II Terminated
FDA drug recall D-0181-2024 was initiated by CARDINAL HEALTHCARE on January 26, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. The recall status is terminated (terminated September 29, 2024). Affected quantity: 1 unit.
Recall Details
- Product Type
- Drugs
- Report Date
- January 3, 2024
- Initiation Date
- January 26, 2022
- Termination Date
- September 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Distribution Pattern
Nationwide USA
Code Information
Batch 21025A