Drug recall D-199-2013
Product
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.
Lots and codes
Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14
Recall details
- Recalling firm
- AstraZeneca LP, Westborough, MA
- Quantity
- 64675 cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 11, 2013
- Terminated
- July 26, 2013
Related products
- Pulmicort Respules – drug information
- NDC 0186-1988 Pulmicort Respules · Budesonide .25 mg/2mL · AstraZeneca Pharmaceuticals LP
- NDC 0186-1989 Pulmicort Respules · Budesonide .5 mg/2mL · AstraZeneca Pharmaceuticals LP
- NDC 0186-1990 Pulmicort Respules · Budesonide 1 mg/2mL · AstraZeneca Pharmaceuticals LP