Recall D-0580-2024
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
Recall D-0580-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0580-2024 |
Event ID | 94842 |
Distribution | USA Nationwide |
Quantity | 52,998 |
Recall Reason | Subpotent drug: out of specification results |
Drug Classification | Class III |
Drug Code Info | 20240710 |
Recall Initiation Date | 20240618 |
Report Date | 20240710 |
Classification Date | 20240702 |
Address | 1009 Slater Rd Ste 210BN/A Durham, NC 27703-8446 United States |
Recalling Firm | Accord Healthcare, Inc. |
Initial Notification | Letter |
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