FDA recall D-0528-2023

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., Durham, NC 27703, NDC 16729-533-08.

Reason for recall

Sub-potent drug: assay test result below specifications at 9-month timepoint.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-03-29

Report date

2023-04-12

Termination date

2025-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0528-2023