FDAFDA · Food and drugs·Recall number D-0528-2023
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.
Published April 12, 2023 · Recall initiated: March 29, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sub-potent drug: assay test result below specifications at 9-month timepoint.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- Nationwide in the USA.
- Lot
- Lot #: R2200394 Exp. 03/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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