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Class III: unlikely to cause harmTerminated

AstraZeneca Pulmicort Respules 0 Recall

PULMICORT RESPULES 0

AstraZeneca LP · Westborough, MA

Risk level
Class III
Reported by FDA
Mar 20, 2013
Recall ID
D-199-2013
Check your lot numberHow we source this data

Summary

AstraZeneca recalled Pulmicort Respules 0 starting Jan 11, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-199-2013 on Mar 20, 2013. Reason: Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-199-2013
Classification
Class III
Status
Terminated
Recall initiated
Jan 11, 2013
FDA report date
Mar 20, 2013
Quantity
64675 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
AstraZeneca LP

Original FDA data

Every field from FDA enforcement report D-199-2013, exactly as published.

Show all FDA fields
City
Westborough
State
MA
Status
Terminated
Country
United States
Event ID
64041
Address
50 Otis Street
Code information
Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14
Postal code
01581-4500
Report date
Mar 20, 2013
Product type
Drugs
Recall number
D-199-2013
Classification
Class III
Recalling firm
AstraZeneca LP
Product quantity
64675 cartons
Termination date
Jul 26, 2013
Reason for recall
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Voluntary / mandated
Voluntary: Firm initiated
Product description
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
Distribution pattern
Nationwide
Recall initiation date
Jan 11, 2013
Initial firm notification
Letter
Center classification date
Mar 12, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-199-2013, published Mar 20, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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