FDAClass IIAugust 15, 2012

Albuterol Sulfate Inhalation Solution recall: Sterility Concern

Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only…

Why was Albuterol Sulfate Inhalation Solution recalled?

Lack of Assurance of Sterility

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 #: A0654A, Exp 07/12; A0A62A, Exp 10/12

Product
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only…
Recalling firm
Nephron Pharmaceuticals Corp.
Quantity
56,028 cartons
Distribution
Nationwide and Puerto Rico
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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