FDAClass IIJanuary 3, 2024

ALBUTEROL SULFATE HFA Inhalation Aerosol recall: CGMP Deviations

ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories…

Why was ALBUTEROL SULFATE HFA Inhalation Aerosol recalled?

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

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?

Batch MY7E

Product
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories…
Recalling firm
CARDINAL HEALTHCARE
Quantity
2 cartons
Distribution
Nationwide USA
Recall date
January 3, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls