Vitalab Pharmacy, Inc recalls Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Recalled May 16, 2018 · FDA recall D-0728-2018 · Vitalab Pharmacy
Hazard
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products. · FDA Class II
Units
178 vials
Sold at
The recalled product was distributed to patients throughout the United States.
Description
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Product
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Manufacturer(s)
Vitalab Pharmacy, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →