June 2015 FDA Recall Drug by Astrazeneca Pharmaceuticals Lp
D-1141-2015 - Presence of Foreign Tablets/Capsules

This Class II drug recall was voluntarily initiated by Astrazeneca Pharmaceuticals Lp on June 10, 2015 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1141-2015

Reason for Recall
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Initiated
06-10-2015
Reported
06-24-2015
Quantity
34,524 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71483
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AstraZeneca Pharmaceuticals LP
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide to wholesalers for further distribution at the retail level.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-27-2016
Product Description About Product Description
Full technical description of the product.
NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.

Batch or Lot Expiration Information

Lot# FC0064; Exp. 05/17