Dodex Injectable Cyanocobalamin Recalled Due to Subpotent Drug Defect
Accord Healthcare is recalling Dodex Injectable (Cyanocobalamin) due to subpotency; affected batches contain less active ingredient than labeled. Patients using affected lots should contact their healthcare provider.
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: This is an FDA Class III recall for a drug potency defect where the product contains less active ingredient than labeled. No illnesses or injuries have been reported. While subpotency represents an actual product-quality issue warranting regulatory action, cyanocobalamin is a relatively safe agent; the defect affects therapeutic efficacy rather than creating direct toxicity risk, supporting Moderate severity.
Plain-English summary
Accord Healthcare, Inc. is recalling Dodex Injectable (Cyanocobalamin Injection) USP, 1,000 mcg/mL in 1 mL multiple-dose vials. Testing identified that certain batches contain less active pharmaceutical ingredient than specified on the label, resulting in out-of-specification test results.
The affected product was distributed nationwide. Approximately 52,998 units are involved. The recalled lot numbers include R2200834, R2200835, R2200841, R2200958 (expiring 06/30/2024); R2201044, R2201045, R2201046, R2201047, R2201095, R2201142, R2201143, R2201144 (expiring 07/31/2024); and M2215870, M2215918 (expiring 10/2024).
Patients currently taking medication from the affected lots should contact their healthcare provider. Because the recalled batches are subpotent and may not provide the intended therapeutic benefit, healthcare providers can advise patients on appropriate next steps.
The recalled product
- Product
- Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Injectable
- Affected units
- 52,998
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 (15)
- Lot# R2200834
- R2200835
- R2200841
- R2200958
- Exp 06/30/2024
- R2201044 R2201045 R2201046
- R2201047
- R2201095
- R2201142
- R2201143
- R2201144
- Exp 07/31/2024
- M2215870
- M2215918
- Exp 10/2024
Distribution
Distributed nationwide across the United States.
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