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Recall D-0528-2023

Description: 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.

Recall D-0528-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0528-2023
Event ID91977
DistributionNationwide in the USA.
Quantity4574 cartons
Recall ReasonSub-potent drug: assay test result below specifications at 9-month timepoint.
Drug ClassificationClass III
Drug Code Info20230412
Recall Initiation Date20230329
Report Date20230412
Classification Date20230406
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification E-Mail
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