Reported Apr 12, 2023 · Terminated
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or…
Accord Healthcare, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
- 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 byIntas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08
- Lot codes and dates
- Lot #: R2200394 Exp. 03/2024
- Amount recalled
- 4574 cartons
Where it was sold
- Nationwide
Why it was recalled
Sub-potent drug: assay test result below specifications at 9-month timepoint.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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