Multi-event May 2016 FDA Recall Drug by Sandoz, Inc

This Multi-event Class III drug recall was voluntarily initiated by Sandoz, Inc on May 2, 2016 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1045-2016 TERMINATED D-1046-2016 TERMINATED

Recall Number: D-1045-2016

Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Initiated
05-02-2016
Reported
06-29-2016
Quantity
78,606 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74068
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz, Inc
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-17-2017
Product Description About Product Description
Full technical description of the product.
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01

Batch or Lot Expiration Information

Lot# s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017

Recall Number: D-1046-2016

Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Initiated
05-02-2016
Reported
06-29-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74068
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz, Inc
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-17-2017
Product Description About Product Description
Full technical description of the product.
Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01

Batch or Lot Expiration Information

Lot# : EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017