July 2020 FDA Recall Drug by Bausch Health Companies, Inc.
D-0054-2021 - SUBPOTENT DRUG

This Class II drug recall was voluntarily initiated by Bausch Health Companies, Inc. on July 13, 2020 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0054-2021

Reason for Recall
SUBPOTENT DRUG
Initiated
07-13-2020
Reported
11-04-2020
Quantity
35424 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86557
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.
Bausch Health Companies, 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 within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-03-2022
Product Description About Product Description
Full technical description of the product.
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15

Batch or Lot Expiration Information

Lot# : 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021