FDA-Drug2023-04-12Class III
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.
Accord Healthcare, Inc.
Hazard
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Sold states
Nationwide in the USA.
Affected count
4574 cartons
Manufactured in
1009 Slater Rd Ste 210B, Durham, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0528-2023Don't want to check this manually?
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