Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x ...
FDA Recall #D-0790-2022 — Class III — April 12, 2022
Product Description
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
Reason for Recall
Subpotent Drug: Out of specification for assay.
Recalling Firm
American Health Packaging — Columbus, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
97,975 vials
Distribution
Alabama
Code Information
Lots: CCC210008, CCC210009, Exp. 01/23
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated