Lithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion
Cardinal Healthcare recalled Lithium Carbonate Extended-Release Tablets (300 mg, Batch 3138326) distributed nationwide because the products were exposed to temperatures outside their labeled storage conditions during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The products are risk-of-harm items (a prescription drug exposed to improper storage conditions), but actual harm has not been reported, meeting the criterion for High severity.
Plain-English summary
Cardinal Healthcare is recalling Lithium Carbonate Extended-Release Tablets, USP, 300 mg (100 tablets per bottle, NDC 0378-1300-01, Batch 3138326), manufactured for Mylan Pharmaceuticals Inc. This recall applies to all units distributed nationwide.
The recall was issued due to a Current Good Manufacturing Practice (CGMP) deviation. During manufacturing, the products were exposed to temperatures outside the labeled storage conditions.
Patients currently taking this product should contact their healthcare provider or pharmacist to determine whether they have received an affected batch and to discuss appropriate next steps. Patients should not discontinue use without medical guidance.
The recalled product
- 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
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Hazard
- temperature-excursion
- improper-storage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch 3138326
Distribution
Distributed nationwide across the United States.
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