Accord Healthcare, Inc.: Drug Recall

Recall #D-0580-2024 · 06/18/2024

Class III: Low Risk

Recall Details

Recall Number: D-0580-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Accord Healthcare, Inc.
Status: Terminated
Date Initiated: 06/18/2024
Location: Durham, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 52,998

Reason for Recall

Subpotent drug: out of specification results

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

Distribution Pattern

USA Nationwide

Other Recalls by Accord Healthcare, Inc.

Class II: Risk 09/16/2025

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification

View all recalls by Accord Healthcare, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.