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FDA (Drug enforcement)Recalled 2012-07-26closedclass ii

GlaxoSmithKline Inc: 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

Is my product affected?

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

  • Brand VENTOLIN

Check against the official notice below — it lists the full affected range.

What happened

GlaxoSmithKline Inc. is recalling 1,412,566 Ventolin HFA (albuterol sulfate) inhalation aerosols distributed nationwide. The affected inhalers contain a potential albuterol dose below the specified amount and therefore may not deliver the proper metered dose. The recall affects specific lot numbers with expiration dates ranging from January 2013 to April 2013, including lots 1ZP7355, 1ZP7749, 1ZP8141, 1ZP8147, 1ZP7729, 1ZP0414, 1ZP0464, 1ZP0570, 1ZP0576, 1ZP0919, 2ZP4959, and 2ZP4966.

The recall record does not specify what action affected consumers should take regarding this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. Distribution: Nationwide Quantity: 1,412,566 inhalers Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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