Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: DND0058A, Exp. Date 12/2023
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0083-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 20, 2023
- FDA report date
- Nov 8, 2023
- Quantity
- 7392 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0083-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93256
- Address
- 2 Independence Way
- Code information
- Lot #: DND0058A, Exp. Date 12/2023
- Postal code
- 08540-6620
- Report date
- Nov 8, 2023
- Product type
- Drugs
- Recall number
- D-0083-2024
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 7392 Bottles
- Termination date
- Jul 25, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2023