Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutan
Summary
The FDA issued a Class III for Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple d by Accord Healthcare, Inc.. Reason: Sub-potent drug: assay test result below specifications at 9-month timepoint..
Details
Source
Drug Recall
External ID
D-0528-2023
Action Date
2023-04-12
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot #: R2200394 Exp. 03/2024
Quantity Affected: 4574 cartons
Reason for Recall
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-29
Company
Durham, NC
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 70 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Accord Healthcare, Inc. has 90 FDA actions in our database, including 90 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accord Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accord Healthcare, Inc. have FDA actions?
Accord Healthcare, Inc. has 90 FDA actions in our database, including 90 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0528-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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