Drug product
Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59
D-0790-2022
Product summary
- Event
- Event 90003
- Status
- Terminated
- Classification
- Class III
- Quantity
- 97,975 vials
- Official record key
drug-enforcement:D-0790-2022
Official wording
Reason: Subpotent Drug: Out of specification for assay.
Code information: Lots: CCC210008, CCC210009, Exp. 01/23
Distribution pattern: Alabama
Derived failure modes
-
Potency or specification failure
Subpotent