FDA recall D-0790-2022

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

Reason for recall

Subpotent Drug: Out of specification for assay.

Distribution

Alabama

Key facts

Status

Terminated

Initiation date

2022-04-12

Report date

2022-05-04

Termination date

2022-12-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0790-2022