AstraZeneca Recalls Pulmicort Respules Due to Budesonide Concentration Variance
AstraZeneca is recalling Pulmicort Respules because the budesonide concentration 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 FDA classified this as a Class III recall, 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 Inhalation Suspension) because the product does not meet the monograph. Specifically, the budesonide concentration may be slightly above or below the established specification range.
The recall involves 28,476 cartons of Pulmicort Respules 0.25 mg/2 ml (30 ampules/carton) with NDC 0186-1988-04. The affected lots are AH0054 (Exp 5/14) and AK0125 (Exp 7/14). The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- PULMICORT RESPULES (BUDESONIDE)
- Brand
- PULMICORT RESPULES
- Manufacturer
- AstraZeneca LP
- Category
- Drug — Inhalation Suspension
- Hazard
- Affected units
- 28,476
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 (2)
- Lot/Exp date: AH0054 Exp 5/14
- AK0125 Exp 7/14
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
- LowAstraZeneca Recalls PULMICORT RESPULES Due to Budesonide Specification Deviation
FDA (Drugs) · 2013-03-20
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