Pulmicort Respules Suspension
FDA Recall NDC 0186-1990
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Pulmicort Respules (NDC 0186-1990). A significant event, classified as Class III, was initiated on Jan 11, 2013 by Astrazeneca Pharmaceuticals Lp. The reported reason for this action was: "Does Not Meet Monograph: Budesonide may be slightly above or below the specification range."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Jan 11, 2013
Mar 20, 2013
28,476 cartons
Recall Profile & Regulatory Data
Event ID
64041
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AstraZeneca LP
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 26, 2013
Product Description
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
Batch or Lot Expiration Information
Lot# Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14
Affected Packages Involved in this Recall
0186-1988-04Product
0186-1989-04Product
0186-1990-04Product
Class III Terminated
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Jan 11, 2013
Mar 20, 2013
64675 cartons
Recall Profile & Regulatory Data
Event ID
64041
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AstraZeneca LP
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 26, 2013
Product Description
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
Batch or Lot Expiration Information
Lot# Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14
Affected Packages Involved in this Recall
0186-1988-04Product
0186-1989-04Product
0186-1990-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
