D-199-2013 Class III Terminated
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
- 64675 cartons
Product Description
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
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: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14