The Recall Desk
LowFDA (Drugs)·D-199-2013·Announced 2013-03-20

AstraZeneca Recalls PULMICORT RESPULES Due to Budesonide Specification Deviation

AstraZeneca is recalling PULMICORT RESPULES because the budesonide content may be slightly above or below the specification range.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

AstraZeneca LP is recalling PULMICORT RESPULES (budesonide) 0.5 mg/2 ml, 30 ampules/carton. The recall involves 64,675 cartons distributed nationwide. The specific lots affected are YP0035 (Exp 11/13), YP0140 (Exp 12/13), YP0136 (Exp 12/13), AB0077 (Exp 2/14), and AH0133 (Exp 5/14).

The reason for the recall is that the product does not meet the monograph, as the budesonide content may be slightly above or below the specification range. This is an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences.

Consumers and healthcare providers should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be returned to the distributor or the manufacturer for credit. Patients should consult their healthcare provider regarding alternative treatments if they have questions about their medication.

The recalled product

Product
PULMICORT RESPULES (BUDESONIDE)
Brand
PULMICORT RESPULES
Manufacturer
AstraZeneca LP
Category
Drug — Inhalation Suspension
Hazard
Affected units
64,675

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AstraZeneca LP under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · PULMICORT RESPULES

Same hazard · specification deviation

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