D-0187-2024 Class II Terminated
FDA drug recall D-0187-2024 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
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Distribution Pattern
Nationwide USA
Code Information
Batch A5921