D-0580-2024 Class III Terminated
FDA drug recall D-0580-2024 was initiated by Accord Healthcare, Inc. on Jun 18, 2024 and is designated Class III. Reason for recall: Subpotent drug: out of specification results The recall status is terminated (terminated Feb 12, 2026). Affected quantity: 52,998.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 10, 2024
- Initiation Date
- Jun 18, 2024
- Termination Date
- Feb 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0580-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026