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Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations...

FDA Recall #D-1666-2012 — Class II — July 26, 2012

Recall #D-1666-2012 Date: July 26, 2012 Classification: Class II Status: Terminated

Product Description

Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20

Reason for Recall

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

Recalling Firm

GlaxoSmithKline Inc — Zebulon, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1,412,566 inhalers

Distribution

Nationwide

Code Information

Lot 1ZP7355 Exp. 01/13, 1ZP7749 Exp. 01/13, 1ZP8141 Exp. 01/13, 1ZP8147 Exp. 01/13, 1ZP7729 Exp. 01/13, 1ZP0414 Exp. 03/13, 1ZP0464 Exp. 03/13, 1ZP0570 Exp. 03/13, 1ZP0576 Exp. 03/13, 1ZP0919 Exp. 03/13, 2ZP4959 Exp. 04/13, 2ZP4966 Exp. 04/13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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