Accord Healthcare recalls Dodex Injectable Cyanocobalamin Injection due to sub-potent drug levels at 9-month testing. This may affect treatment effectiveness. Consumers should check product details and contact manufacturer for guidance.
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Accord Healthcare is recalling Dodex Injectable Cyanocobal: the product may have lower-than-stated drug levels after 9 months, which could reduce treatment effectiveness. This recall affects patients using the injection for vitamin B12 therapy.
The product may have lower-than-stated drug levels after 9 months of storage, which could reduce treatment effectiveness. This is a sub-potent issue, meaning the active ingredient concentration is below the required standard for proper medical use.
Patients using Dodex Injectable Cyanocobalamin Injection for vitamin B12 therapy. Those who have the product from the specified lot number and expiration date are most at risk.
Check for the product name 'Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials' with lot number R2200394 and expiration date 03/2024.
Look for the lot number R2200394 and expiration date 03/2024 on the vial packaging.
The recall indicates the product may have lower-than-stated drug levels after 9 months, which could reduce treatment effectiveness. It is not recommended for use until the manufacturer provides guidance.
Check the product details for the lot number R2200394 and expiration date 03/2024. Contact Accord Healthcare for specific instructions.
The recall is for sub-potent drug levels, which may affect treatment effectiveness but does not indicate a risk of serious injury.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0528-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0528-2023 from Accord Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
