D-198-2013 Class III Terminated
FDA drug recall D-198-2013 was initiated by AstraZeneca LP on January 11, 2013 and is designated Class III. Reason for recall: Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. The recall status is terminated (terminated July 26, 2013). Affected quantity: 28,476 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2013
- Initiation Date
- January 11, 2013
- Termination Date
- July 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,476 cartons
Product Description
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
Reason for Recall
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Distribution Pattern
Nationwide
Code Information
Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14