C-CROMOLYN SOD 20 MG/ INHALATION SOLUTION recalled over sterility concerns

Recall date

July 24, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Colonia Care Pharmacy recalls C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman…

Recall number

D-0008-2020

FDA classification

Class II

Brand / firm

Colonia Care Pharmacy

Sold / distributed

Patient Specific Prescriptions in NJ

Why it was recalled

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067