D-0528-2023 Class III Terminated
FDA drug recall D-0528-2023 was initiated by Accord Healthcare, Inc. on March 29, 2023 and is designated Class III. Reason for recall: Sub-potent drug: assay test result below specifications at 9-month timepoint. The recall status is terminated (terminated March 19, 2025). Affected quantity: 4574 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- March 29, 2023
- Termination Date
- March 19, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4574 cartons
Product Description
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.
Reason for Recall
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: R2200394 Exp. 03/2024