FDA Drug recall D-0189-2024
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Mor…
- FDA Drug
- Class II
- terminated
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Mor… by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0189-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Healthcare |
| Distribution | US |
Product
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
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Identifiers
| code_info | Batch 3138326 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0189-2024%22
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