Accord Healthcare, Inc.: Drug Recall

Recall #D-0528-2023 · 03/29/2023

Class III: Low Risk

Recall Details

Recall Number
D-0528-2023
Classification
Class III
Product Type
Drug
Recalling Firm
Accord Healthcare, Inc.
Status
Terminated
Date Initiated
03/29/2023
Location
Durham, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4574 cartons

Reason for Recall

Sub-potent drug: assay test result below specifications at 9-month timepoint.

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.

Distribution Pattern

Nationwide in the USA.

Other Recalls by Accord Healthcare, Inc.

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.