Why it was recalled
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Product description
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
Lot numbers, UPCs & expiration codes
Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14
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-198-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 11, 2013
- FDA report date
- Mar 20, 2013
- Quantity
- 28,476 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AstraZeneca LP
Original FDA data
Every field from FDA enforcement report D-198-2013, 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: AH0054 Exp 5/14; AK0125 Exp 7/14
- Postal code
- 01581-4500
- Report date
- Mar 20, 2013
- Product type
- Drugs
- Recall number
- D-198-2013
- Classification
- Class III
- Recalling firm
- AstraZeneca LP
- Product quantity
- 28,476 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 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 11, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2013