Home / Recalls / Accord Healthcare, Inc. / D-0580-2024

D-0580-2024 Class III Terminated

Recalled by Accord Healthcare, Inc. — Durham, NC

Recall Details

Product Type
Drugs
Report Date
July 10, 2024
Initiation Date
June 18, 2024
Termination Date
February 12, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
52,998

Product Description

Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308

Reason for Recall

Subpotent drug: out of specification results

Distribution Pattern

USA Nationwide

Code Information

Lot# R2200834, R2200835, R2200841, R2200958, Exp 06/30/2024; R2201044 R2201045 R2201046, R2201047, R2201095, R2201142, R2201143, R2201144, Exp 07/31/2024; M2215870, M2215918, Exp 10/2024

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-0522-2025 Class II — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Onl (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-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-0519-2025 Class II — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-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-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)