Multi-event January 2013 FDA Recall Pulmicort Respules by Astrazeneca Lp
This Multi-event Class III drug recall was voluntarily initiated by Astrazeneca Lp on January 11, 2013 for the product Pulmicort Respules. The FDA reported the reason for recall as does not meet monograph. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-198-2013
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
01-11-2013
03-20-2013
28,476 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AstraZeneca LP
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-26-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
Batch or Lot Expiration Information
Lot# Lot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14
Affected Packages Involved in this Recall
Recall Number: D-199-2013
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
01-11-2013
03-20-2013
64675 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AstraZeneca LP
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-26-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
Batch or Lot Expiration Information
Lot# Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14
