Accord Healthcare, Inc. recalls Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutan
Recalled April 12, 2023 · FDA recall D-0528-2023 · Accord Healthcare
Hazard
Sub-potent drug: assay test result below specifications at 9-month timepoint. · FDA Class III
Units
4574 cartons
Sold at
Nationwide in the USA.
Description
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Product
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.
Manufacturer(s)
Accord Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →