Reported Apr 12, 2023 · Terminated

Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or…

Accord Healthcare, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446

Is this the product you have?

  • 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 byIntas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA
  • Manufactured forAccord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08
Lot codes and dates
  • Lot #: R2200394 Exp. 03/2024
Amount recalled
4574 cartons

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 19, 2025 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.