Home / Recalls / ACCORD HEALTHCARE, INC. / D-0030-2025

D-0030-2025 Class II Ongoing

Recalled by ACCORD HEALTHCARE, INC. — Raleigh, NC

Recall Details

Product Type
Drugs
Report Date
November 6, 2024
Initiation Date
October 10, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

Reason for Recall

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Distribution Pattern

Nationwide in the USA and PR

Code Information

a) Lot #: Expiry Date: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b) Lot #: Expiry Date: M2210808 06/2025 M2212212 08/2025 M2214435 09/2025 M2217097 11/2025 M2301921 01/2026

Other recalls by ACCORD HEALTHCARE, INC.

  • D-0006-2026 Class II — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx (September 16, 2025)
  • D-0523-2025 Class II — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only (June 20, 2025)
  • D-0518-2025 Class II — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, (June 20, 2025)
  • D-0524-2025 Class II — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Onl (June 20, 2025)
  • D-0522-2025 Class II — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Onl (June 20, 2025)
  • D-0519-2025 Class II — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only (June 20, 2025)
  • D-0520-2025 Class II — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, M (June 20, 2025)
  • D-0521-2025 Class II — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, (June 20, 2025)
  • D-0394-2025 Class II — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Man (April 10, 2025)
  • D-0395-2025 Class II — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manu (April 10, 2025)