D-0189-2024 Class II Terminated
FDA drug recall D-0189-2024 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
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Distribution Pattern
Nationwide USA
Code Information
Batch 3138326