ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 1...
FDA Recall #D-0162-2024 — Class II — January 26, 2022
Product Description
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling Firm
CARDINAL HEALTHCARE — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2 cartons
Distribution
Nationwide USA
Code Information
Batch MY7E
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated