Recalls / Class II
Class IID-0083-2024
Product
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, 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 #: DND0058A, Exp. Date 12/2023
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
- 7392 Bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-10-20
- FDA classified
- 2023-11-01
- Posted by FDA
- 2023-11-08
- Terminated
- 2024-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0083-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.