PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 10, 2024 Initiated: June 18, 2024 #D-0580-2024

Product Description

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

Details

Recalling Firm
Accord Healthcare, Inc.
Units Affected
52,998
Distribution
USA Nationwide
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by Accord Healthcare, Inc.. Units affected: 52,998.
Why was this product recalled?
Subpotent drug: out of specification results
Which agency issued this recall?
This recall was issued by the FDA Drug on July 10, 2024. Severity: Low. Recall number: D-0580-2024.