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Class III: unlikely to cause harmTerminated

Accord Healthcare Dodex Injectable Cyanocobalamin Injection Recall

Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose via…

Accord Healthcare, Inc. · Durham, NC

Risk level
Class III
Reported by FDA
Apr 12, 2023
Recall ID
D-0528-2023
Check your lot numberHow we source this data

Summary

Accord Healthcare recalled Dodex Injectable Cyanocobalamin Injection starting Mar 29, 2023. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0528-2023 on Apr 12, 2023. Reason: Sub-potent drug: assay test result below specifications at 9-month timepoint. Status: Terminated.

Why it was recalled

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.

Lot numbers, UPCs & expiration codes

Lot #: R2200394 Exp. 03/2024

Where it was sold

Nationwide in the USA.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0528-2023
Classification
Class III
Status
Terminated
Recall initiated
Mar 29, 2023
FDA report date
Apr 12, 2023
Quantity
4574 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Accord Healthcare, Inc.

Original FDA data

Every field from FDA enforcement report D-0528-2023, exactly as published.

Show all FDA fields
City
Durham
State
NC
Status
Terminated
Country
United States
Event ID
91977
Address
1009 Slater Rd Ste 210B
Code information
Lot #: R2200394 Exp. 03/2024
Postal code
27703-8446
Report date
Apr 12, 2023
Product type
Drugs
Recall number
D-0528-2023
Classification
Class III
Recalling firm
Accord Healthcare, Inc.
Product quantity
4574 cartons
Termination date
Mar 19, 2025
Reason for recall
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Voluntary / mandated
Voluntary: Firm initiated
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.
Recall initiation date
Mar 29, 2023
Initial firm notification
E-Mail
Center classification date
Apr 6, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0528-2023, published Apr 12, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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