Dodex Injectable (Accord Healthcare) – Subpotent Drug (2024)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Accord Healthcare, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Accord Healthcare, Inc. is recalling Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manuf due to Subpotent drug: out of specification results. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent drug: out of specification results
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026