Recalls / Class II
Class IID-0150-2024
Product
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88
- Brand name
- Liothyronine Sodium
- Generic name
- Liothyronine Sodium
- Active ingredient
- Liothyronine Sodium
- Route
- Oral
- NDCs
- 62756-589, 62756-590, 62756-591
- FDA application
- ANDA091382
- Affected lot / code info
- Lot DND0059A Expires 12/2023 Lot DND0060A Expires 12/2023 Lot DND0061A Expires 12/2023 Lot DND0062A Expires 01/2024 Lot DND0063A Expires 01/2024 Lot DND0064A Expires 01/2024 Lot DND0065A Expires 01/2024 Lot DND0180A Expires 01/2024 Lot DND0181A Expires 01/2024 Lot DND0182A Expires 01/2024 Lot DND0183A Expires 01/2024 Lot DND0184A Expires 01/2024 Lot DND0597A Expires 02/2024
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 96,192 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-12-04
- FDA classified
- 2023-12-14
- Posted by FDA
- 2023-12-20
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0150-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.