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.
Reported: April 12, 2023 Initiated: March 29, 2023 #D-0528-2023
Product 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.
Reason for Recall
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Details
- Recalling Firm
- Accord Healthcare, Inc.
- Units Affected
- 4574 cartons
- Distribution
- Nationwide in the USA.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accord Healthcare, Inc.. Units affected: 4574 cartons.
Why was this product recalled? ▼
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 12, 2023. Severity: Low. Recall number: D-0528-2023.
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