May 2018 FDA Recall Hydrocortisone by Perrigo New York
D-0817-2018 - Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Perrigo New York on May 7, 2018 for the product Hydrocortisone. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0817-2018

Reason for Recall
Failed Stability Specifications
Initiated
05-07-2018
Reported
05-23-2018
Quantity
571,632 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80049
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.
Perrigo New York
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.
US Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-10-2018
Product Description About Product Description
Full technical description of the product.
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02

Batch or Lot Expiration Information

Lot# Lot Numbers: 7AT0283V, exp. 11/18 7AT0284V, exp. 11/18 7AT0285V, exp. 11/18 7FT0460, exp. 05/19 7FT0461, exp. 05/19 7GT0465, exp. 06/19 7GT0466, exp. 06/19 7JT0390, exp. 08/19 7JT0392, exp. 08/19 7KT0588, exp. 09/19 7KT0589, exp. 09/19

Affected Packages Involved in this Recall

45802-004-02 Hydrocortisone
45802-004-03 Hydrocortisone
45802-014-02 Hydrocortisone
45802-014-05 Hydrocortisone