Multi-event February 2017 FDA Recall Drug by L. Perrigo Company

This Multi-event Class III drug recall was voluntarily initiated by L. Perrigo Company on February 13, 2017 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-0504-2017 TERMINATED D-0503-2017 TERMINATED

Recall Number: D-0504-2017

Reason for Recall
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Initiated
02-13-2017
Reported
03-08-2017
Quantity
10,656 units total for both products

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76443
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.
L. Perrigo Company
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 within United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-26-2017
Product Description About Product Description
Full technical description of the product.
Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.

Batch or Lot Expiration Information

Lot# : 098840, 098779, Exp.06/18.

Recall Number: D-0503-2017

Reason for Recall
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Initiated
02-13-2017
Reported
03-08-2017
Quantity
10,656 units total for both products

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76443
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.
L. Perrigo Company
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 within United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-26-2017
Product Description About Product Description
Full technical description of the product.
Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.

Batch or Lot Expiration Information

Lot# : 099534, Exp. 07/18; 099512 Exp. 06/18.