Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27…
ACCORD HEALTHCARE, INC. · Subpotent Drug
- Status
- Ongoing
- City
- Raleigh
- State
- NC
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99584
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address 1
- 8041 Arco Corporate Dr Ste 200
- Address 2
- N/A
- Postal code
- 27617-2010
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
- Recall number
- D-0776-2026
- Product quantity
- N/A
- Reason for recall
- Subpotent Drug
- Recall initiation date
- 20260806
- Center classification date
- 20260821
- Report date
- 20260902
- Code info
- Lot #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, Exp Date. 11/30/2026.
- Product description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
- Harmonized identifiers (openFDA)
- Application number
- ANDA212399
- Brand name
- LEVOTHYROXINE SODIUM
- Generic name
- LEVOTHYROXINE SODIUM
- Manufacturer name
- Accord Healthcare Inc.
- Product NDC
- 16729-447, 16729-458, 16729-448, 16729-449, 16729-451, 16729-450, 16729-452, 16729-453, 16729-454, 16729-455, 16729-456, 16729-457
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LEVOTHYROXINE SODIUM
- RxCUI
- 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270
- SPL ID
- 415fc774-31a5-124f-e063-6294a90a0e46
- SPL set ID
- a6233381-3043-4e9a-aaa6-a6b105e5142b
- Package NDC
- 16729-458-15, 16729-458-17, 16729-447-15, 16729-447-17, 16729-448-15, 16729-448-17, 16729-449-15, 16729-449-17, 16729-451-15, 16729-451-17, 16729-450-15, 16729-450-17, 16729-452-15, 16729-452-17, 16729-453-15, 16729-453-17, 16729-454-15, 16729-454-17, 16729-455-15, 16729-455-17, 16729-456-15, 16729-456-17, 16729-457-15, 16729-457-17
- Is original packager
- true
- Upc
- 0316729447157, 0316729449151, 0316729452151, 0316729454155, 0316729453158, 0316729448154, 0316729451154, 0316729457156, 0316729450157, 0316729456159, 0316729458153, 0316729455152
- UNII
- 9J765S329G