Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For In...
FDA Recall #D-0528-2023 — Class III — March 29, 2023
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.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4574 cartons
Distribution
Nationwide in the USA.
Code Information
Lot #: R2200394 Exp. 03/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated