D-199-2013 Class III Terminated

Recalled by AstraZeneca LP — Westborough, MA

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