Class III
Terminated
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.
- Company
- Accord Healthcare, Inc.
- Recall Initiated
- March 29, 2023
- Posted
- April 12, 2023
- Recall Number
- D-0528-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4574 cartons
- Firm Location
- Durham, NC, United States
Reason for Recall
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot #: R2200394 Exp. 03/2024
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