FDAClass IIIMarch 20, 2013

Pulmicort Respules 0.5 Mg/2 Ml recall

PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04

Why was Pulmicort Respules 0.5 Mg/2 Ml recalled?

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

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/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14

Product
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
Recalling firm
AstraZeneca LP
Quantity
64675 cartons
Distribution
Nationwide
Recall date
March 20, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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