FDA Drug Moderate Class II Terminated

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

Reported: October 9, 2019 Initiated: July 24, 2019 #D-0008-2020

Product Description

Reason for Recall

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

Details

Recalling Firm: Colonia Care Pharmacy
Units Affected: 60 nebulizer vials
Distribution: Patient Specific Prescriptions in NJ
Location: Colonia, NJ

Frequently Asked Questions

What product 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. Recalled by Colonia Care Pharmacy. Units affected: 60 nebulizer vials.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on October 9, 2019. Severity: Moderate. Recall number: D-0008-2020.