FDA recall D-0580-2024

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

Reason for recall

Subpotent drug: out of specification results

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2024-06-18

Report date

2024-07-10

Termination date

2026-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

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