Liothyronine Sodium Tablets Recalled for Failed Impurity and Degradation Specifications
Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.
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: FDA Class II recall with no reported illnesses or injuries. Impurities or degradation in a prescription thyroid medication represents a risk-of-harm scenario, meeting the criterion for High severity despite the absence of documented harm.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling 7,392 bottles of Liothyronine Sodium Tablets, USP, 5 mcg (NDC 62756-589-88, Lot DND0058A, expiration 12/2023) due to failed impurity and degradation specifications. The tablets were manufactured by Sun Pharmaceutical Industries Ltd in India and distributed nationwide in the United States.
The recall affects patients who have been prescribed tablets from the affected lot. Liothyronine Sodium is a prescription thyroid hormone medication.
Patients currently taking tablets from the recalled lot should contact their healthcare provider for guidance. Consumers with unused tablets from this lot should not use them and should consult their healthcare provider or pharmacist about proper disposal.
The recalled product
- Product
- LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
- Brand
- LIOTHYRONINE SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Thyroid Hormone
- Hazard
- impurity
- degradation
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 (2)
- Lot #: DND0058A
- Exp. Date 12/2023
Distribution
Distributed nationwide across the United States.
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- ModerateLiothyronine Sodium tablets recalled due to failed impurity and degradation specifications
FDA (Drugs) · 2023-12-20
- HighLiothyronine Sodium Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2023-11-08
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