Drug product
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
D-199-2013
Product summary
- Firm
- AstraZeneca LP
- Event
- Event 64041
- Status
- Terminated
- Classification
- Class III
- Quantity
- 64675 cartons
- Official record key
drug-enforcement:D-199-2013
Official wording
Reason: Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Code information: Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.