Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
Reported: July 23, 2025 Initiated: June 20, 2025 #D-0521-2025
Product Description
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
Reason for Recall
Subpotent Drug: Assay below the approved specification
Details
- Recalling Firm
- ACCORD HEALTHCARE, INC.
- Units Affected
- 9,739 bottles
- Distribution
- Nationwide in the USA
- Location
- Raleigh, NC
Frequently Asked Questions
What product was recalled? ▼
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17. Recalled by ACCORD HEALTHCARE, INC.. Units affected: 9,739 bottles.
Why was this product recalled? ▼
Subpotent Drug: Assay below the approved specification
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2025. Severity: Moderate. Recall number: D-0521-2025.
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