FDA-Drug2024-07-10Class III

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

Accord Healthcare, Inc.
Hazard

Subpotent drug: out of specification results

Sold states
USA Nationwide
Affected count
52,998
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0580-2024

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