Cyanocobalamin injection vials recalled for failing potency tests
Accord Healthcare recalled 4,574 cartons of Cyanocobalamin injection (Lot R2200394) nationwide after testing showed the drug was sub-potent and failed to meet strength specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses. The product's sub-potency is a quality defect more significant than cosmetic issues (score 1) but less severe than reported injuries (scores 3+). Class III recalls typically score 1 or 2; this defect warrants a score of 2 (Moderate).
Plain-English summary
Accord Healthcare is recalling Cyanocobalamin injection (Lot R2200394, expiration 03/2024) manufactured by Intas Pharmaceuticals Limited. Testing revealed the drug was sub-potent, with assay test results falling below the specified potency level at the 9-month timepoint. The product is a vitamin B12 injection supplied in multiple-dose vials for intramuscular or subcutaneous use.
A total of 4,574 cartons of the affected product were distributed nationwide in the United States. Patients and healthcare providers who have received or dispensed the recalled lot should verify whether their product is affected.
Sub-potency means the drug does not meet the strength specifications on its label. Patients using this medication from the affected lot should contact their healthcare provider about next steps. For more information, visit the FDA's drug recalls page.
The recalled product
- Product
- 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.…
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Injectable / Vitamin B12
- Hazard
- Affected units
- 4,574
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: R2200394 Exp. 03/2024
Distribution
Distributed nationwide across the United States.
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