FDAClass IIOctober 9, 2019

C-cromolyn SOD 20 Mg/2 ML Inhalation Solution recall: Sterility Concern

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.…

Why was C-cromolyn SOD 20 Mg/2 ML Inhalation Solution recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 070219B, BUD 08/06/19

Product
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.…
Recalling firm
Colonia Care Pharmacy
Quantity
60 nebulizer vials
Distribution
Patient Specific Prescriptions in NJ
Recall date
October 9, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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